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

Arm | Intervention/treatment |
---|---|
Active Comparator: Control Arm
Subjects undergoing trabeculectomy with the use of Mitomycin C
|
Procedure: Trabeculectomy
Standard trabeculectomy procedure
|
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:
|
- 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 ]
- 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 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
Principal Investigator: | Peter A. Netland, MD, PhD | University of Virginia |
Additional Information:
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 |