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Summary

for people ages 18–85 (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.

Details

Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such as Ahmed valve implantation, which are conventional surgeries performed to control intraocular pressure in eyes, are sometimes associated with complications due to fibrosis. Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.

Keywords

Glaucoma Primary Open Angle Glaucoma Secondary Glaucoma Neovascular Glaucoma Glaucoma, Open-Angle Glaucoma, Neovascular Pharmaceutical Solutions Mitomycins Mitomycin

Eligibility

You can join if…

Open to people ages 18–85

  • Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg. Ahmed Glaucoma Valve (AGV)implantation as the planned surgical procedure. For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.

You CAN'T join if...

  • Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
  • Pregnant or nursing women.
  • Previous cyclodestruction or glaucoma drainage device (GDD) surgery.
  • Patients with nanophthalmos.
  • Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
  • No light perception vision.
  • VA <20/200 in non-study eye.
  • Need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
  • Previous scleral buckling procedure or silicone oil present. Uveitic glaucoma.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco, California, 94121, United States
  • Asociación para Evitar la Ceguera en México (APEC) accepting new patients
    Mexico City, Mexico
  • Zhongshan Ophthalmic Center accepting new patients
    Guangzhou, Guangdong, China
  • Shri Ganesh Vinayak Eye Hospital accepting new patients
    Raipur, Chhattisgarh, India

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02805257
Phase
Phase 2
Lead Scientist
Ying Han
Study Type
Interventional
Last Updated
November 7, 2017
I’m interested in this study!