Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?
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.
Drug: balanced salt solution BSS
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Intraocular pressure (IOP) [ Time Frame: Data collected prior to surgery (Baseline visit), 1 day, 1week, 1 month, 3 month and 6 month post-op visits ] [ Designated as safety issue: No ]
- anterior chamber inflammation measurement is taken 10 times using the Kowa FM-500 flare meter per eye [ Time Frame: Data collected 1 month, 3 month and 6 month post-op visits ] [ Designated as safety issue: Yes ]
- Observation of Triesence Crystals by slit lamp exam combined with gonioscopy [ Time Frame: Data collected 1 day, 1 week, 1 month, 3 month, and 6 month post-op visits ] [ Designated as safety issue: Yes ]
- bleb morphology graded by Indiana Bleb Appearance Grading Scale (IBAGS) and the Moorfields Bleb Grading System (MBGS) [ Time Frame: IBAGS assessed at 1 day, 1 week, 1 month, 3 month and 6 month post-op visits; Moorfields Bleb Grading will be done at 1 month, 3 month, and 6 month post-op visits ] [ Designated as safety issue: No ]
- Lens opacities classification using Lens Opacities Classifications System III (LOCS III) [ Time Frame: Assessesd at baseline, month 3 and month 6 post-operative visit ] [ Designated as safety issue: Yes ]
- A patient comfort questionnaire [ Time Frame: Patients will be quiered at 1 day, 1 week, 1 month, 3 month and 6 month post-op visit ] [ Designated as safety issue: No ]
- ocular hypotensive medications [ Time Frame: Ocular medications will be documented during the 1 day, 1 week, 1 month, 3 month, and or 6 month post-operative period ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment 1(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
Other Name: triamcinolone acetonide injectable
Active Comparator: Treatment 2 (balanced salt solution BSS)
glaucoma surgery with balanced salt solution, the standard technique used.
Drug: 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.
Other Name: balanced salt solution
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853905
|United States, Pennsylvania|
|Wills Eye Institute|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Marlene R Moster, MD||Wills Eye Institute|