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

Phase 2

Completed

• Conditions: Glaucoma
• Interventions: Drug: balanced salt solution BSS; Drug: Triesence

• Registration Number: NCT00853905
• Lead Sponsor: Wills Eye

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-27
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Results First Submitted: 2015-02-12
• Results First Submitted QC: 2016-03-02
• Results First Posted: 2016-03-21
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 2 (balanced salt solution BSS)	balanced salt solution BSS	glaucoma surgery with balanced salt solution, the standard technique.
Treatment 1(Triesence)	Triesence	glaucoma surgery with 0.2cc Triesence adjunct.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	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.

Secondary Outcome Measures

Name	Time	Method
Patient Comfort	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	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.
Anterior Chamber Inflammation (Flare)	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	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.

Trial Locations

Locations (1)

Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States