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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.
Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1(Triesence) | Experimental | glaucoma surgery with 0.2cc Triesence adjunct. |
|
| Treatment 2 (balanced salt solution BSS) | Active Comparator | glaucoma surgery with balanced salt solution, the standard technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triesence | Drug | At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was <21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg. | 1 day, 1week, 1 month, 3 month and 6 month post-op visits |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Chamber Inflammation (Flare) | Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec). | 1 month, 3 month and 6 month post-op visits |
| Bleb Appearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene R Moster, MD | Wills Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24794283 | Result | Koval MS, Moster MR, Freidl KB, Waisbourd M, Jain SG, Ichhpujani P, Myers JS, Pro MJ. Intracameral triamcinolone acetonide in glaucoma surgery: a prospective randomized controlled trial. Am J Ophthalmol. 2014 Aug;158(2):395-401.e2. doi: 10.1016/j.ajo.2014.04.027. Epub 2014 May 2. |
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February 2009 to July 2011 at the Wills Eye Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment 1(Triesence) | 0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound. |
| FG001 | Treatment 2 (Balanced Salt Solution BSS) | glaucoma surgery with balanced salt solution, the standard technique. At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment 1(Triesence) | 0.2cc Triesence Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Intraocular Pressure (IOP) | Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was <21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg. | Posted | Mean | 95% Confidence Interval | mm Hg | 1 day, 1week, 1 month, 3 month and 6 month post-op visits |
|
surgery, day 1, 1 week, 1 month, 3 month, 6 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment 1(Triesence) | 0.2cc Triesence Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IOP failure | Eye disorders | Non-systematic Assessment | IOP failed to drop 20% or less than a 5mmhg drop from original IOP; eye drops added |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marlene Moster MD | Wills Eye Hospital Glaucoma Research Center | 215-825-4713 | jmolineaux@willseye.org |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D015812 | Glaucoma, Angle-Closure |
| D017889 | Exfoliation Syndrome |
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| C072670 | Hanks Balanced Salt Solution |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
|
| balanced salt solution BSS | Drug | At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure. |
|
|
A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery. |
| 1 day, 1 week, 1 month, 3 month and 6 month post-op visits |
| Patient Comfort | Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale. | 1 day, 1 week, 1 month, 3 month and 6 month post-op visits |
| Ocular Hypotensive Medications | Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure. | 1 week, 1 month, 3 month, and or 6 month post-op visits |
| never had surgery |
|
| Treatment 2 (Balanced Salt Solution BSS) |
glaucoma surgery with balanced salt solution, the standard technique used. balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Interocular Pressure (mmHg) | Median | Full Range | mmHg |
|
balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure. |
|
|
| Secondary | Anterior Chamber Inflammation (Flare) | Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec). | Posted | Mean | 95% Confidence Interval | photon counts per millisecond (p/msec) | 1 month, 3 month and 6 month post-op visits |
|
|
|
| Secondary | Bleb Appearance | A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery. | Bleb assessment by IBAGS was not obtained at all visits. Overall, 20 of 37 (Triesence) and 20 of 40 (BSS) blebs were measured. | Posted | Mean | 95% Confidence Interval | units on a scale | 1 day, 1 week, 1 month, 3 month and 6 month post-op visits |
|
|
|
| Secondary | Patient Comfort | Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale. | Posted | Mean | 95% Confidence Interval | Patient comfort questionnaire score | 1 day, 1 week, 1 month, 3 month and 6 month post-op visits |
|
|
|
| Secondary | Ocular Hypotensive Medications | Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure. | Posted | Mean | 95% Confidence Interval | eye drops | 1 week, 1 month, 3 month, and or 6 month post-op visits |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 8 |
| 37 |
| EG001 | Treatment 2 (Balanced Salt Solution BSS) | glaucoma surgery with balanced salt solution, the standard technique used. balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure. | 0 | 40 | 0 | 40 | 10 | 40 |
|
| choroidals drained; A/C reformed | Eye disorders | Non-systematic Assessment | patient needed another glaucoma procedure |
|
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| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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