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

Sponsored by:	University of Witwatersrand, South Africa
Information provided by:	University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier:	NCT00698438

Purpose

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.

Condition	Intervention	Phase
Glaucoma	Device: Ex-PRESS implantation Procedure: Trabeculectomy	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Witwatersrand, South Africa:

Primary Outcome Measures:

Mean IOP and surgical success rates. na [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	March 2005
Estimated Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
a: Active Comparator 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. Procedure: Trabeculectomy standard trabeculectomy
b: Active Comparator Trabecolectomy	Procedure: Trabeculectomy standard trabeculectomy

Arms

Assigned Interventions

a: Active Comparator

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.

Procedure: Trabeculectomy

standard trabeculectomy

b: Active Comparator

Trabecolectomy

Procedure: Trabeculectomy

standard trabeculectomy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698438

Locations

South Africa
Department of Ophthalmology, University of the Witwatersrand,
Johannesburg,, South Africa

Sponsors and Collaborators

University of Witwatersrand, South Africa

More Information

Responsible Party:	( Elie Dahan )
Study ID Numbers:	XVT-USF
Study First Received:	March 4, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00698438
Health Authority:	South Africa: Department of Health

Keywords provided by University of Witwatersrand, South Africa:

At least 18 years of age
Open-angle glaucoma

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009