Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?
Information source: Wills Eye
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: Triesence (Drug); balanced salt solution BSS (Drug)
Phase: Phase 2/Phase 3
Sponsored by: Wills Eye
Official(s) and/or principal investigator(s):
Marlene R Moster, MD, Principal Investigator, Affiliation: Wills Eye Institute
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.
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Intraocular pressure (IOP)
anterior chamber inflammation measurement is taken 10 times using the Kowa FM-500 flare meter per eye
Observation of Triesence Crystals by slit lamp exam combined with gonioscopy
bleb morphology graded by Indiana Bleb Appearance Grading Scale (IBAGS) and the Moorfields Bleb Grading System (MBGS)
Lens opacities classification using Lens Opacities Classifications System III (LOCS III)
A patient comfort questionnaire
ocular hypotensive medications
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.
Minimum age: 21 Years.
Maximum age: N/A.
- glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy
plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube;
- primary open angle glaucoma
- primary angle-closure glaucoma
- pseudoexfoliation glaucoma
- pigmentary glaucoma
- traumatic glaucoma
- neovascular glaucoma
- 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
Locations and Contacts
Wills Eye Institute, Philadelphia, Pennsylvania 19107, United States
Starting date: February 2009
Last updated: January 29, 2015