Clinical Trial: Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Intraoperative Mitomycin C Application, Amniotic Membrane Transplantation and Conjunctival Autograft After Primary Pterygium Excision: A Multi-center Randomized Clinical T

Brief Summary: The purpose of this randomized multi-center clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence.

Detailed Summary: Patients with primary pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C application,amniotic membrane transplantation or conjunctival autograft in five clinical centers. Multi-center collaboration and quality monitoring will be based on a website designed for this study. The patients will be followed at least 12 months. Corneal Recurrence as the primary outcome measure, is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag.
Sponsor: Sun Yat-sen University

Current Primary Outcome: Recurrence of pterygium [ Time Frame: One year ]

Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag


Original Primary Outcome: Recurrence of pterygium [ Time Frame: One year ]

Current Secondary Outcome:

  • Visual acuity [ Time Frame: One year ]
  • Healing time of corneal epithelium [ Time Frame: Four weeks ]
  • Healing time of conjunctival epithelium [ Time Frame: Four weeks ]
  • Postoperative complications [ Time Frame: One year ]


Original Secondary Outcome: Intraoperative and Postoperative Complications [ Time Frame: One year ]

Information By: Sun Yat-sen University

Dates:
Date Received: March 31, 2014
Date Started: December 2015
Date Completion: December 2017
Last Updated: December 16, 2015
Last Verified: December 2015