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

June 12, 2008 updated by: University of Witwatersrand, South Africa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • a:Ex-PRESS implantation
Procedure: Trabeculectomy
standard trabeculectomy
ACTIVE_COMPARATOR: b
Trabecolectomy
Procedure: Trabeculectomy
standard trabeculectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean IOP and surgical success rates. na

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Witwatersrand, South Africa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion

August 1, 2007

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (ESTIMATE)

June 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 12, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XVT-USF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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