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

NCT00698438 | Completed Phase 4 DMC

• 1 other identifier: XVT-USF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

At least 18 years of age; Open-angle glaucoma

Outcome Measures

Primary Outcomes (1)

• Mean IOP and surgical success rates. na

Study Arms (2)

a

ACTIVE COMPARATOR

Implantation of Ex-PRESS mini glaucoma shunt under a scleral flap

Device: Ex-PRESS implantation; Procedure: Trabeculectomy

b

ACTIVE COMPARATOR

Trabecolectomy

Procedure: Trabeculectomy

Interventions

Ex-PRESS implantation DEVICE

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.

Also known as: a:Ex-PRESS implantation

a

Trabeculectomy PROCEDURE

standard trabeculectomy

a; b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead

Study Sites (1)

Department of Ophthalmology, University of the Witwatersrand,

Johannesburg, South Africa

Location

Related Publications (1)

• 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.

  PMID: 36912740 DERIVED

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: June 17, 2008
• Study Start: March 1, 2005
• Primary Completion: August 1, 2007
• Last Updated: June 17, 2008

Record last verified: 2008-06

Locations

ZA (1)