Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?
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|ClinicalTrials.gov Identifier: NCT00853905|
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : March 21, 2016
Last Update Posted : July 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: Triesence Drug: balanced salt solution BSS||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
Experimental: Treatment 1(Triesence)
glaucoma surgery with 0.2cc Triesence adjunct.
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.
Other Name: triamcinolone acetonide injectable
Active Comparator: Treatment 2 (balanced salt solution BSS)
glaucoma surgery with balanced salt solution, the standard technique.
Drug: balanced salt solution BSS
At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
Other Name: balanced salt solution
- Intraocular Pressure (IOP) [ Time Frame: 1 day, 1week, 1 month, 3 month and 6 month post-op visits ]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.
- Anterior Chamber Inflammation (Flare) [ Time Frame: 1 month, 3 month and 6 month post-op visits ]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).
- Bleb Appearance [ Time Frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits ]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.
- Patient Comfort [ Time Frame: 1 day, 1 week, 1 month, 3 month and 6 month post-op visits ]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.
- Ocular Hypotensive Medications [ Time Frame: 1 week, 1 month, 3 month, and or 6 month post-op visits ]Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853905
|United States, Pennsylvania|
|Wills Eye Institute|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Marlene R Moster, MD||Wills Eye Institute|