Clinical Trial: Ahmed Glaucoma Valve Surgery With Mitomycin-C

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Ahmed Glaucoma Valve Surgery With Mitomycin-C

Brief 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.

Detailed Summary: 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.
Sponsor: University of California, San Francisco

Current Primary Outcome: Intraocular pressure after surgery [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Intraocular pressure after surgery [ Time Frame: 1 year ]
  • Number of medications postoperatively [ Time Frame: 6 months ]
  • Complications [ Time Frame: 6 months ]
  • Endothelial cell count [ Time Frame: 6 months ]
  • Visual Acuity [ Time Frame: 6 months ]
  • Number of medications [ Time Frame: 1 year ]
  • Complications [ Time Frame: 1 year ]
  • Endothelial cell count [ Time Frame: 1 year ]
  • Visual acuity [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: June 15, 2016
Date Started: June 2016
Date Completion: October 2017
Last Updated: June 16, 2016
Last Verified: June 2016