Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Triesence
* Drug: balanced salt solution BSS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube) primary open angle glaucoma primary angle-closure glaucoma pseudoexfoliation glaucoma pigmentary glaucoma traumatic glaucoma neovascular glaucoma Exclusion Criteria: patients that are pregnant, nursing, or not using adequate contraception any other eye surgery except cataract surgery an infection, inflammation, or any abnormality preventing measurement of eye pressure enrolled in another investigational study

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1(Triesence)<br>glaucoma surgery with 0.2cc Triesence adjunct. | Drug: Triesence<br>* 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.<br>* Other names: triamcinolone acetonide injectable;|
| Active Comparator: Treatment 2 (balanced salt solution BSS)<br>glaucoma surgery with balanced salt solution, the standard technique. | Drug: balanced salt solution BSS<br>* At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.<br>* Other names: balanced salt solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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open angle glaucoma (POAG), angle closure glaucoma (PACG), pigmentary glaucoma, pseudoexfoliation glaucoma, neovascular glaucoma, traumatic glaucoma