Comparison Of Trabeculectomy Versus The Ex-PRESS Miniature Glaucoma Device In The Same Patient: A Prospective Randomized Study

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Device: Ex-PRESS implantation; Procedure: Trabeculectomy

• Registration Number: NCT00698438
• Lead Sponsor: University of Witwatersrand, South Africa

Brief Summary

the purpose of this study was to compare standard trabeculectomy to the Ex-PRESS mini glaucoma shunt implantation under a scleral flap in eyes with open-angle glaucoma.In this report, we describe the results of a prospective, randomized trial in which subjects with bilateral primary open-angle glaucoma underwent the two procedures in fellow eyes.Design: Prospective, randomized clinical trial.

Participants: 15 subjects with bilateral primary open-angle glaucoma Methods: Subjects underwent the two procedures in fellow eyes. Safety and efficacy were evaluated for up to two years.

Main Outcome Measures: Mean IOP and surgical success rates. Results: Mean IOP was similar in Ex-PRESS and trabeculectomy eyes at all time points except month 9, when Ex-PRESS eyes had lower mean IOP (13.2 mmHg vs 16.5 mmHg, respectively; p=0.025). Percent IOP reduction was also similar at all time points except postoperative day 1, when trabeculectomy eyes were lower (75.5% vs 65.8%, respectively; p=0.003), likely due to a higher rate of early hypotony in trabeculectomy eyes versus Ex-PRESS eyes (47% vs 7%, respectively). Complete (without medications) and qualified (with or without medications) successes were more common at all IOP cut-off values in Ex-PRESS eyes than trabeculectomy eyes at last visit (p=0.015, p=0.015 respectively). Postoperative complications were uncommon in both groups, but trabeculectomy eyes required more postoperative interventions than Ex-PRESS eyes.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Primary Completion: 2007-08
• Study First Submitted: 2008-03-04
• Status Verified: 2008-06
• Study First Submitted QC: 2008-06-12
• Last Update Submitted: 2008-06-12
• Study First Posted: 2008-06-17
• Last Update Posted: 2008-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects were at least 18 years of age and
• Had medically uncontrolled primary open-angle glaucoma requiring incisional surgery for reduction of intraocular pressure in both eyes.
• Subjects with prior cataract or failed filtration surgery in either eye were eligible to participate if surgery occurred at least 3 months prior to enrollment.

Exclusion Criteria

• Any form of glaucoma other than primary open-angle glaucoma;
• History of or active uveitis; or
• Any ocular abnormality that would prevent accurate assessment of intraocular pressure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
a	Ex-PRESS implantation	Implantation of Ex-PRESS mini glaucoma shunt under a scleral flap
a	Trabeculectomy	Implantation of Ex-PRESS mini glaucoma shunt under a scleral flap
b	Trabeculectomy	Trabecolectomy

Primary Outcome Measures

Name	Time	Method
Mean IOP and surgical success rates. na

Trial Locations

Locations (1)

Department of Ophthalmology, University of the Witwatersrand,; 🇿🇦 Johannesburg,, South Africa