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

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

August 31, 2007

Conditions
Glaucoma
Interventions
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."

PROCEDURE

Trabeculectomy

standard trabeculectomy

Trial Locations (1)

Unknown

Department of Ophthalmology, University of the Witwatersrand,, Johannesburg

All Listed Sponsors
lead

University of Witwatersrand, South Africa

OTHER

NCT00698438 - Comparison Of Trabeculectomy Versus The Ex-PRESS Miniature Glaucoma Device In The Same Patient: A Prospective Randomized Study | Biotech Hunter | Biotech Hunter