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

Condition(s) targeted: Glaucoma

Intervention: Triesence (Drug); balanced salt solution BSS or viscoelastic (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Wills Eye

Official(s) and/or principal investigator(s):
Marlene R Moster, MD, Principal Investigator, Affiliation: Wills Eye Institute

Overall contact:
Jeanne L Molineaux, COA, Phone: 215-825-4713, Email: jmolineaux@willseye.org

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, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Intraocular pressure (IOP)

Secondary outcome:

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

Detailed description: 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. Gender(s): Both.

Criteria:

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

Jeanne L Molineaux, COA, Phone: 215-825-4713, Email: jmolineaux@willseye.org

Wills Eye Institute, Philadelphia, Pennsylvania 19107, United States; Recruiting
Jeanne L Molineaux, COA, Phone: 215-825-4713, Email: jmolineaux@willseye.org
Sheryl Wizov, COA, Phone: 215-928-3221, Email: swizov@willseye.org
George L Spaeth, MD, Sub-Investigator
Michael Pro, MD, Sub-Investigator
L. Jay Katz, MD, Sub-Investigator
Jonathan Myers, MD, Sub-Investigator
Courtland Schmidt, MD, Sub-Investigator
Scott Fudemberg, MD, Sub-Investigator
Parul Khator, MD, Sub-Investigator

Starting date: February 2009
Last updated: June 24, 2010