Clinical Trial: To Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation

Brief Summary: The purpose of this study is to compared between conventional pterygium excision and AMT transplantation with suture and with fibrin glue.

Detailed Summary:

There are few studies about use of fibrin glue in pterygium surgery with conjunctival auto-graft with promising outcome. Less recurrent rate, less discomfort and halve surgical time were reported.

Up to our knowledge,there is no report of fibrin glue in pterygium excision with amniotic membrane transplantation(AMT). There is conventional technique to use AMT in King Chulalongkorn Memorial Hospital because some benefits over conjunctival auto-graft e.g.

  • Preserve healthy superior conjunctiva for future glaucoma filtering surgery
  • Can use in big or 2-headed pterygium
  • Not contract as conjunctival graft esp. in case of fibrin glue
  • Potential easier to use with fibrin glue
  • Available from Thai Red Cross Eye Bank Comparison(s): amniotic membrane transplantation using fibrin glue compare to suture after pterygium excision.

Sponsor: Chulalongkorn University

Current Primary Outcome: Pain and discomfort during and after surgery using visual analog scale [ Time Frame: during surgery and after surgery up to 30 days ]

Original Primary Outcome: Pain and discomfort during and after surgery using visual analog scale

Current Secondary Outcome:

  • Surgical time [ Time Frame: start and to the end of surgery ]
  • Healing of epithelial defect on cornea and AMT [ Time Frame: until 30 days ]
  • Postoperative inflammation [ Time Frame: up to 30 days ]
  • Complications e.g. Recurrent, graft loss/dehiscent, re-operation [ Time Frame: until last follow up ]


Original Secondary Outcome:

  • Surgical time
  • Healing of epithelial defect on cornea and AMT
  • Postoperative inflammation
  • Complications e.g. Recurrent, graft loss/dehiscent, re-operation


Information By: Chulalongkorn University

Dates:
Date Received: April 4, 2007
Date Started: April 2007
Date Completion:
Last Updated: February 12, 2008
Last Verified: February 2008