Intraocular Pressure (IOP) Patterns in Fast Versus Slow V... | NCT01828255

NCT01828255

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SENSIMED Triggerfish®	Experimental	Device: portable device that monitors the 24-hour IOP pattern by a wireless contact lens sensor placed on the eye that sends its signals via an antenna around the orbital cavity to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization.	Device: SENSIMED Triggerfish®

Name	Type	Description	Arm Group Labels	Other Names
SENSIMED Triggerfish®	Device		SENSIMED Triggerfish®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.	24-hour measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.	24-hour

Secondary Outcomes

Measure	Description	Time Frame
Relationship Between TF Pattern and VF Progression According to TF Slope	Measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression during wake vs sleep periods. The wake slope corresponds to the change in the TF signal from 1 hour before to 1 hour after the time the subject went to sleep. The sleep slope corresponds to the change from 1 hour before to 1 hour after the time the subject awoke.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 40 and 89 years old
Diagnosis of treated POAG (including normal tension glaucoma (NTG))
All IOP measurements during the VF period (to be described further) equal or lower than 18 mmHg and/or on average equal or lower than 16 mmHg in the same period
Documented glaucomatous VF damage at baseline, characterized by glaucoma hemifield test result outside normal limits on at least 2 consecutive VF tests or the presence of at least 3 contiguous test points within the same hemifield on the pattern deviation plot at p<0.01, with at least 1 point at p < 0.005
At least 8 visual field tests carried out within at least 2 years, all with fixation losses and false positive/negative results equal or less than 33%
For fast progressing eyes, 1) pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or 2) a global rate of VF change based on mean deviation (MD) more negative than -1.0 dB/year
For slowly or minimally progressing eyes a VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression as described above
Not more than 6 diopters spherical equivalent on the study eye
Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

Baseline VF MD more negative than -15 dB. The rationale here is that in severely damaged visual fields, one may not be able to detect and measure rates of progression due to a 'floor effect'
Corneal or conjunctival abnormality precluding contact lens adaptation
Severe dry eye syndrome or other ocular disease
Patients with angle closure glaucoma, traumatic glaucoma or uveitic glaucoma
Patients with previous intraocular surgery in the enrolled eye, including cataract surgery
Patients with allergy to corneal anesthetic
Patients with contraindications for silicone contact lens wear
Patients not able to understand the character and individual consequences of the investigation
Participation in unrelated clinical research within the last 4 weeks

Name	Affiliation	Role
Gustavo De Moraes, MD	The New York Eye and Ear Infirmary	Principal Investigator
Jeffrey M Liebmann, MD	The New York Eye and Ear Infirmary	Principal Investigator
Robert Ritch, MD	The New York Eye and Ear Infirmary	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The New York Eye and Ear Infirmary		New York	New York	10003	United States

Arm/Group Information

ID	Title	Description
FG000	Fast Progressors	pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year
FG001	Slow Progressors	VF MD rate of change more positive than -0.5 dB/year with no significant point defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01wise progression

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Slow Progressors	VF MD rate of change more positive than -0.5 dB/year with no significant pointwise progression defined as two or more adjacent VF test locations in the same hemifield
BG001	Fast Progressors

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Relationship Between 24-hour IOP Pattern as Recorded by TF and VF Progression in Patients With POAG.

24-hour measurement of TF, corresponding to IOP-related fluctuations expressed in arbitrary units of mini volts equivalent (mVeq) and comparison of this measurement between POAG patients showing fast and slow rates of glaucoma visual field progression.

POAG patients with slow or fast rate of VF glaucoma progression

Posted

Mean

Standard Deviation

mVeq

24-hour

ID	Title	Description
OG000	Fast Progressors	Patients with a fast rate of progression (<-1dB/y)
OG001	Slow Progressors	Patients with a slow rate of progression (>-1dB/y)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fast Progressors	Pointwise progression defined as two or more adjacent VF test locations in the same hemifield that show a threshold sensitivity rate of change more negative than -1.0 dB/year with p<0.01 or a global rate of VF change based on MD more negative than -1.0 dB/year

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases