The American Glaucoma Society (AGS) Second Aqueous Shunt... | NCT02691455

Label	Type	Description	Intervention Names
Second Aqueous Shunt	Active Comparator	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used.	Device: Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Device: Ahmed Model FP7 Flexible Plate Device: Baerveldt Glaucoma Implant 250-mm2 / BG103-250
Transscleral Cyclophotocoagulation	Active Comparator	Transscleral Diode Laser Cyclophotocoagulation	Procedure: Transscleral Diode Laser Cyclophotocoagulation

Name	Type	Description	Arm Group Labels	Other Names
Baerveldt Glaucoma Implant 350-mm2 / BG101-350	Device		Second Aqueous Shunt
Transscleral Diode Laser Cyclophotocoagulation

Measure	Description	Time Frame
Number of Eyes That Failed Treatment	Treatment failure is defined as meeting one or more of the following 4 criteria: Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or Reoperation for glaucoma; or Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or Loss of light perception vision (NLP).	from time of intervention to month 6
Number of Eyes That Failed Treatment	Treatment failure is defined as meeting one or more of the following 4 criteria: Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or Reoperation for glaucoma; or Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or Loss of light perception vision (NLP).	from month 6 to month 12
Number of Eyes That Failed Treatment	Treatment failure is defined as meeting one or more of the following 4 criteria: Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or Reoperation for glaucoma; or Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or Loss of light perception vision (NLP).	from month 12 to year 3

Measure	Description	Time Frame
Number of Eyes With Vision-threatening Complications		from the time of intervention to year 3
Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test	The Snellen visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). Loss of lines of vision indicates worsening visual acuity.

Name	Affiliation	Role
Robert Feldman, MD	Robert Cizik Eye Clinic	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego - Shiley Eye Institute		La Jolla	California	92093	United States

PubMed Identifier	Type	Citation	Retractions
26092196	Background	Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015 Aug;122(8):1615-24. doi: 10.1016/j.ophtha.2015.04.015. Epub 2015 Jun 16.
22245458	Background	Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube versus Trabeculectomy Study Group. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012 May;153(5):789-803.e2. doi: 10.1016/j.ajo.2011.10.026. Epub 2012 Jan 15.

ID	Title	Description
FG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 20, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Eyes That Failed Treatment

Treatment failure is defined as meeting one or more of the following 4 criteria:

Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or
Reoperation for glaucoma; or
Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or
Loss of light perception vision (NLP).

Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Number

eyes

from time of intervention to month 6

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Units	Counts
Participants	OG00022 OG00119

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Primary

Number of Eyes That Failed Treatment

Treatment failure is defined as meeting one or more of the following 4 criteria:

Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or
Reoperation for glaucoma; or
Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or
Loss of light perception vision (NLP).

Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 4 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Number

eyes

from month 6 to month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Primary

Number of Eyes That Failed Treatment

Treatment failure is defined as meeting one or more of the following 4 criteria:

Intraocular pressure (IOP) a) >18 mm Hg on maximum tolerated topical IOP-lowering medications, or b) Reduction of < 20% IOP on maximum tolerated topical IOP-lowering medications from medicated preoperative IOP, or c) ≤ 5 mm Hg without IOP-lowering medications on IOP confirmation visit, 6 months after initial study intervention; or
Reoperation for glaucoma; or
Addition of an oral CAI for the study eye on or after the 6-Month Study Visit; or
Loss of light perception vision (NLP).

Only one eye of each participant was eligible for enrollment. Only those who did not fail treatment in the previous time period (previous time period is reported in Outcome measure 2) were analyzed in this time period. Data for this outcome measure were not collected for 15 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Number

eyes

from month 12 to year 3

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation

Secondary

Number of Eyes With Vision-threatening Complications

Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Number

eyes

from the time of intervention to year 3

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Units	Counts
Participants

Secondary

Number of Eyes That Lost Two or More Lines of Vision as Assessed by the Snellen Chart Visual Acuity Test

The Snellen visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). Loss of lines of vision indicates worsening visual acuity.

Only one eye of each participant was eligible for enrollment. Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Number

eyes

from time of intervention to year 3

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The week 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Data for this outcome measure was not collected 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

log MAgnification Requirement (logMAR)

baseline, week 1

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 1 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Data for this outcome measure was not collected for 5 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

log MAgnification Requirement (logMAR)

baseline, month 1

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Data for this outcome measure were not collected for 1 in the Second Aqueous Shunt arm and 3 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

log MAgnification Requirement (logMAR)

baseline, month 3

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 6 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Data for this outcome measure were not collected for 3 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

log MAgnification Requirement (logMAR)

baseline, month 6

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The month 12 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Data for this outcome measure were not collected for 6 in the Second Aqueous Shunt arm and 4 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

log MAgnification Requirement (logMAR)

baseline, month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 2 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Data for this outcome measure were not collected for 16 in the Second Aqueous Shunt arm and 11 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

log MAgnification Requirement (logMAR)

baseline, year 2

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Change in Visual Acuity as Assessed by the Snellen Chart Visual Acuity Test

The visual acuity test is used to determine the smallest letters the participant can read on a standardized chart (Snellen chart). The year 3 reading minus the baseline reading is reported, with a positive number indicating a decrease in visual acuity (that is, an increase in logMAR value indicates a decrease in visual acuity).

Data for this outcome measure were not collected for 16 in the Second Aqueous Shunt arm and 15 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

log MAgnification Requirement (logMAR)

baseline, year 3

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Incidence of Pain

Number of participants who reported pain.

Data for this outcome measure were not collected for 1 in the Second Aqueous Shunt arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Count of Participants

Participants

1 week

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Units	Counts
Participants

Secondary

Incidence of Pain

Number of participants who reported pain.

Data for this outcome measure were not collected for 2 in the Second Aqueous Shunt arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Count of Participants

Participants

1 month

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Units	Counts
Participants

Secondary

Severity of Pain

Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

1 week

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Units	Counts

Secondary

Severity of Pain

Severity of pain was assessed by the Universal Pain Assessment Tool, and the score ranges from 0 to 10, with a higher score indicating greater pain.

Data for this outcome measure were not collected for 2 in the Second Aqueous Shunt arm and 2 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

1 month

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Units	Counts

Secondary

Number of Office Visits Per Participant From Baseline to 3 Months

Data for this outcome measure were not collected 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

office visits per participant

from baseline to 3 months

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Units	Counts
Participants

Secondary

Number of Office Visits Per Participant Per Month After Month 3

Data for this outcome measure were not collected for 2 in the Second Aqueous Shunt arm and 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

office visits per participant per month

from month 4 to year 3

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Units	Counts
Participants

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25 (NEI-VFQ-25) - General Health Subscale

The score on the National Eye Institute (NEI) Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Health Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - General Vision Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Mental Health Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Distance Activity Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Near Activity Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Peripheral Vision Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Color Vision Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Ocular Pain Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Driving Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Dependency Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Social Functioning Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 1 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

baseline

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Secondary

Vision-related Quality of Life as Assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) - Role Difficulty Subscale

The score on the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) subscale ranges from 0 to 100, with a higher score indicating greater functioning.

Data for this outcome measure were not collected for 8 in the Second Aqueous Shunt arm and 7 in the Transscleral Cyclophotocoagulation arm who received the intervention.

Posted

Mean

Standard Deviation

score on a scale

month 12

ID	Title	Description
OG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
OG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.

Term	Organ System	Assessment Type	Statistical Information
Death	General disorders	Systematic Assessment	EG0003 events3 affected22 at risk EG0010 events0 affected20 at risk
Central Nervous System (CNS) Syphilis causing Pan Uveitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Left Lung Malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Hyphema	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Chest pain secondary to abdominal artery pseudoaneurysm	Vascular disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0002 events2 affected22 at risk EG0010 events0 affected20 at risk
Acute on Chronic Combined Diastolic and Systolic Congestive Heart Failure exacerbation	Vascular disorders	Systematic Assessment	EG0002 events1 affected22 at risk EG0010 events0 affected20 at risk
Left atrial myxoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Pericardial effusion	Vascular disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Purulent Constrictive Pericarditis, unspecified infectious etiology	Infections and infestations	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Heart Attack	Vascular disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected20 at risk
Non-ST-Elevation Myocardial Infarction	Vascular disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected20 at risk
Open Globe due to trauma	Eye disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected20 at risk

Term	Organ System	Assessment Type	Statistical Information
Acute on Chronic Respiratory Failure with Hypoxemia and Hypercapnia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Castochondritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Choroidals	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Corneal Epithelial Defect	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Decreased Visual Acuity	Eye disorders	Systematic Assessment	EG0002 events2 affected22 at risk EG0014 events4 affected20 at risk
Development of Cystoid Macular Edema	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0011 events1 affected20 at risk
Worsening of Cystoid Macular Edema	Eye disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected20 at risk
Dislipidemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Diabetic Macular Edema	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0012 events1 affected20 at risk
Ectropion	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Worsening Diabetic Retinopathy	Eye disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected20 at risk
Filamentary Keratitis	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Herpes Simplex Virus Dendritic Keratitis	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Hyphema	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Hypotony of eye	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Leak/Inflammation or infection of eye	Infections and infestations	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Mild intraocular lens dislocation (inferior nasal)	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Overfiltration of Eye	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Pulmonary Hypertension (secondary)	Vascular disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Re-exposed tube	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Ssuperior nasal tube with <1 mm exposure at limbus (original tube)	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Spot on gums	General disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Throat Malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Trabectome/Goniotomy of eye	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Tube Migration Anteriorly	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Vision loss from count fingers to light perception	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Vitreous clogging of second tube shunt	Eye disorders	Systematic Assessment	EG0001 events1 affected22 at risk EG0010 events0 affected20 at risk
Cataract formation	Eye disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0013 events3 affected20 at risk
Worsening of cataract	Eye disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected20 at risk
Macular hole	Eye disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected20 at risk
No light perception	Eye disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected20 at risk
Phacodonesis	Eye disorders	Systematic Assessment	EG0000 events0 affected22 at risk EG0011 events1 affected20 at risk

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

ID	Title	Description
BG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250
BG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Second Aqueous Shunt	Second Aqueous Shunt Either a Baerveldt Glaucoma Implant 350-mm2 BG101-350 or an Ahmed Model FP7 Flexible Plate must be used for all participants unless there is insufficient space, in which case a Baerveldt Glaucoma Implant 250-mm2 BG103-250 may be used. Baerveldt Glaucoma Implant 350-mm2 / BG101-350 Ahmed Model FP7 Flexible Plate Baerveldt Glaucoma Implant 250-mm2 / BG103-250	3	22	6	22	10	22
EG001	Transscleral Cyclophotocoagulation	Transscleral Diode Laser Cyclophotocoagulation Transscleral Diode Laser Cyclophotocoagulation: Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.	0	20	3	20	10	20