MedTrace Logo

Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

NCT00444080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-10-14

Study results available
· View outcomes & findings →

Summary

A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for which filtering surgery is indicated. Surgical success was defined as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further glaucoma surgery. Postoperative intraocular pressure, number of medications, complications and success rates were followed for 2 years.

Conditions

Interventions

PROCEDURE

Trabeculectomy

Standard trabeculectomy procedure 1. Creation of a fornix or limbal based conjunctival flap in upper quadrants 2. Creation of a limbal-based scleral flap extending into clear cornea 3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) 4. Creation of fistula 1mm x 2mm in size 5. Iridectomy 6. Suturing the scleral flap 7. Repositioning of conjunctiva with sutures After procedure, antibiotics \& steroids are administered topically; eye is covered with a pad - patient is discharged.

DEVICE

Ex-PRESS mini shunt

Ex-PRESS implantation procedure: 1. Creation of a fornix or limbal based conjunctival flap in upper quadrants 2. Creation of limbal-based scleral flap extending into clear cornea 3. Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes) 4. Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus 5. Prior to implantation, a thorough mobility check should be performed 6. Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision 7. Withdrawal of introducer 8. Tucking plate under the scleral flap, and verification of its position 9. Suturing scleral flap After implantation procedure, antibiotics \& steroids administered topically; eye is covered with a pad - patient is discharged.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Peter A. Netland, MD, PhD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00444080 on ClinicalTrials.gov