Comparison Of Trabeculectomy Versus The Ex-PRESS Miniature Glaucoma Device In The Same Patient: A Prospective Randomized Study
NCT ID: NCT00698438
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2005-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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a
Implantation of Ex-PRESS mini glaucoma shunt under a scleral flap
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.
Trabeculectomy
standard trabeculectomy
b
Trabecolectomy
Trabeculectomy
standard trabeculectomy
Interventions
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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.
Trabeculectomy
standard trabeculectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of or active uveitis; or
* Any ocular abnormality that would prevent accurate assessment of intraocular pressure
18 Years
ALL
No
Sponsors
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University of Witwatersrand, South Africa
OTHER
Locations
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Department of Ophthalmology, University of the Witwatersrand,
Johannesburg, , South Africa
Countries
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References
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Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.
Other Identifiers
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XVT-USF
Identifier Type: -
Identifier Source: org_study_id