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

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ClinicalTrials.gov Identifier: NCT00444080
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
University of Virginia

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: Trabeculectomy Device: Ex-PRESS mini shunt Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2006
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT00444080     History of Changes
Other Study ID Numbers: 14967
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

Keywords provided by University of Virginia:
Ex-PRESS
TRABECULECTOMY

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