The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device

Completed · Phase 2

Conditions studied: Primary Open Angle Glaucoma

In brief

The primary focus of this study is to assess intraocular pressure and complication rates between patients who receive mitomycin-C using a sponge versus no-sponge.

Key facts

Study ID

NCT02016898

Run by

Duke University

People needed

100

Starts

2014-03-01

Expected to finish

2017-01-17

Last updated by the study team

2018-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women aged 18 years and older at screening.
• Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma.
• Suitable candidate for trabeculectomy with Ex-PRESS glaucoma filtration device with MMC in the superonasal quadrant in the study eye which the physician deems as medically necessary.
• Capable and willing to provide consent

You may not qualify if…

• Unable or unwilling to provide consent
• Any previous ocular surgeries in the study eye preventing placement of the trabeculectomy with Ex-PRESS glaucoma filtration device with mitomycin-C in the superonasal quadrant
• Any previous glaucoma drainage devices in the study eye
• Any abnormality other than glaucoma in the study eye that could affect applanation tonometry.
• Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
• Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1.
• Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Known Pregnancy or Breastfeeding
• Physical and Laboratory Findings
• Conjunctival scarring precluding a superonasal implantation location.
• Vitreous in the anterior chamber.
• Abnormality preventing reliable applanation tonometry in the study eye.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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