CompletedPhase 2

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

United States100 participantsStarted 2014-03

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Complication Rates

Timeframe: post-operative day 1 to month 6

Trial details

NCT IDNCT02016898

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-17

Results submitted2018-01-11

View on ClinicalTrials.gov More Primary Open Angle Glaucoma trials