Comparison Of Trabeculectomy Versus The Ex-PRESS Miniature Glaucoma Device In The Same Patient: A Prospective Randomized Study (XVT-USF)
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.
Device: Ex-PRESS implantation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Prospective, Randomized Clinical Trial,to Compare Standard Trabeculectomy to the Ex-PRESS Mini Glaucoma Shunt Implantation Under a Scleral Flap in Eyes With Open-Angle Glaucoma|
- Mean IOP and surgical success rates. na [ Designated as safety issue: Yes ]
|Study Start Date:||March 2005|
|Estimated Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Active Comparator: a
Implantation of Ex-PRESS mini glaucoma shunt under a scleral flap
Device: Ex-PRESS implantation
I. Mobility check of the device. II. Administration of a local or topical anesthetic. III. Preparation and coverage of the eye by conventional sterile procedures. IV. Injection of viscoelastic material into the AC through a paracenthesis. V. Creation of a scleral tunnel up to clear cornea. VI. Creation of a (5 mm) conjunctival tunnel fornix based. VII. Lifting of the conjunctiva and tenon. VIII. Formation of a 2mm scleral incision at 0.3mm depth, 1.5mm from the limbus. IX. Application of 0.5µg/ml MMC under the tunnel for one minute.
X. Penetration into the AC using a 0.65mm stiletto, inside the tunnel of the sclera-corneal junction.
XI. Implantation of the Ex-PRESSTM through that pre-incision at the sclerocorneal junction.
XII. Introducer withdrawal. XIII. Tucking the plate under the scleral tunnel, and verification of the position inside the tunnel.
XIV. Reposition the conjunctiva with 1 - 2 sutures at the limbus. XV. Closing the conjunctiva with a suture.
Other Name: a:Ex-PRESS implantationProcedure: Trabeculectomy
Active Comparator: b
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698438
|Department of Ophthalmology, University of the Witwatersrand,|
|Johannesburg,, South Africa|