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

Sponsor
University of Witwatersrand, South Africa (Other)
Overall Status
Completed
CT.gov ID
NCT00698438
Collaborator
(none)
30
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Ex-PRESS implantation
  • Procedure: Trabeculectomy
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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
Study Start Date :
Mar 1, 2005
Primary Completion Date :
Aug 1, 2007

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Mean IOP and surgical success rates. na []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, University of the Witwatersrand, Johannesburg, South Africa

    Sponsors and Collaborators

    • University of Witwatersrand, South Africa

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00698438
    Other Study ID Numbers:
    • XVT-USF
    First Posted:
    Jun 17, 2008
    Last Update Posted:
    Jun 17, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    At least 18 years of age
    Open-angle glaucoma
    Additional relevant MeSH terms:
    Glaucoma

    Study Results

    No Results Posted as of Jun 17, 2008