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

This study has been completed.
Sponsor:
Information provided by:
University of Witwatersrand, South Africa
ClinicalTrials.gov Identifier:
NCT00698438
First received: March 4, 2008
Last updated: June 12, 2008
Last verified: June 2008
History of Changes
  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 4

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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
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 implantation
Procedure: Trabeculectomy
standard trabeculectomy
Active Comparator: b
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

No publications provided

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

Keywords provided by University of Witwatersrand, South Africa:
At least 18 years of age
Open-angle glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013