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OpenTrials
Completed

NCT Number: NCT02016898

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

Placement of the sponge

Procedure

mitomycin-C

Drug

Primary outcomes

  1. Complication Rates

    Time frame: post-operative day 1 to month 6

    To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation

Secondary outcomes

  1. Change in Intraocular Pressure

    Time frame: post-operative day 1 to month 6

    To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2013
Registry last updated
Feb 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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