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

September 21, 2020 updated by: Peter Netland, MD, University of Virginia

A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5B 1N5
        • Osler Eyecare
  • United States
    • California
      • San Francisco, California, United States, 94143-0730
        • University of California
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean A. McGee Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19066
        • Wills Eye Institute
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Ophthalmic & Orbital Associates, P.C.
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subject over the age of 18
  • Subject diagnosed with open angle glaucoma (POAG, PXFG or PDSG) or ocular hypertension
  • Subject is a candidate for filtering surgery with intraoperative anti-metabolites
  • IOP > 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit.
  • Subject willing to attend all follow-up evaluations
  • Subject willing to sign informed consent.

Exclusion Criteria:

  • Subject diagnosed with: PACG, NTG, secondary glaucoma, neovascular glaucoma
  • Subject has history of glaucoma surgery (filtering, glaucoma drainage device, cyclo destructive procedures)
  • Subject has history of penetrating keratoplasty (PKP)
  • Subject underwent large incision extra capsular cataract extraction
  • Subject had cataract phacoemulsification within the last month
  • Subject has a visually significant cataract that is planned for extraction at the time of filtering surgery or within 12 months thereafter
  • Any ocular disease or history in the operated eye other than glaucoma and cataract, such as uveitis, ocular infection, severe dry eye, severe blepharitis , active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, aphakia, and ocular pathology that may interfere with accurate IOP measurements
  • Subject has vitreous present in the anterior chamber for which vitrectomy is anticipated
  • IOP of ≤18mmHg
  • Subject participates in any other concurrent ocular investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm
Subjects undergoing trabeculectomy with the use of Mitomycin C
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.
Experimental: Treatment Arm
Subjects undergoing Ex-PRESS Under Scleral Flap implantation procedure with the use of Mitomycin C
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Intraocular Pressure
Time Frame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
Mean postoperative intraocular pressure
assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
Medications
Time Frame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported
assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Incidence of Adverse Events
Time Frame: 24 months
Comparison of the incidence of all adverse events that occur during the intra-operative and postoperative periods between the two study arms. More than 1 complication may have occurred in the same subject.
24 months
Efficacy - The Number of Participants With Qualified and Complete Success
Time Frame: 24 months
The secondary effectiveness measure will be qualified and complete success rate defined as IOP≤18mmHg with or without medications in the test group as compared to qualified and complete success rate in the concurrent control group at 24 month
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Peter A. Netland, MD, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

March 5, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (Estimate)

March 7, 2007

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14967

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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