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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT00444080
First received: March 5, 2007
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Glaucoma
 Procedure: Trabeculectomy
Device: Ex-PRESS mini shunt
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Safety - Post operative safety profile defined as vitreous loss and hypotony (IOP≤5mmHg) and related complications (choroidal effusion, hyphema, shallow/flat AC, leaking bleb). [ Time Frame: 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m ] [ Designated as safety issue: No ]
  • Efficacy - The primary effectiveness measure will be qualified and complete success rate defined as IOP≤18mmHg with or without medications in the test group as compared to complete and qualified success rate in the concurrent control group at 12 months. [ Time Frame: 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety - Comparison of the incidence of all adverse events that occur during the intra-operative and postoperative periods between the two study arms. [ Time Frame: 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m ] [ Designated as safety issue: No ]
  • Efficacy - 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 [ Time Frame: 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444080

Locations
United States, California
University of California
San Francisco, California, United States, 94143-0730
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, Oklahoma
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Wills EYE Institute
Philadelphia, Pennsylvania, United States, 19066
Allegheny Ophthalmic & Orbital Associates, P.C.
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
Canada
Osler Eyecare
Brompton, Canada
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Peter A. Netland, MD, PhD University of Virginia
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00444080     History of Changes
Other Study ID Numbers: 14967
Study First Received: March 5, 2007
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Ex-PRESS
TRABECULECTOMY

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013