Clinical Trial: The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns

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

Official Title:

Brief Summary: This is a randomized clinical trial study to identify the role of AMT (amniotic membrane transplantation) in treating epithelial defect, symblepharon prevention preventing corneal vascularization and opacity decreasing pain and improving visual acuity, and patients with acute chemical burns.

Detailed Summary:

The study is on patients with grade II-IV acute ocular chemical burns (Roper - Hall classification) in the first 2 weeks of injury.

After topical anesthesia, all patients initially will receive first aid therapy; which included irrigation with normal saline to normalize ocular surface PH and removal of early particulate maeuil and debris. After complete examination and obtaining informed consent, the patients will be randomized using a treatment assignment list to either AMT with conventional medical therapy (group A) or medical treatment only (group B). In the patients with bilateral injuries the eyes will be randomized separately. AMT will be performed within 24h of presentation. amniotic membrane will remain in place for 7-14 days. The patients will be examined at days 1, 3, 7, 10, 14, 21, 28 and then biweekly until 3 months and monthly until (1 year in every visit, visual acuity (by sneillen charts), reduction of pain (subjectively) size of corneal epithelial defect (by fluorseein satiny extent of corneal vascularization and opacity, and symblepharon formation will be assessed. Digital photographs at each visit will be obtained.


Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome:

  • Visual acuity [ Time Frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year ]
  • Pain [ Time Frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year ]
  • Symblepharon formation [ Time Frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year ]
  • Epithelial defect healing [ Time Frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year ]
  • Corneal opacity and vascularization [ Time Frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year ]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: August 31, 2006
Date Started: July 2006
Date Completion: January 2009
Last Updated: September 23, 2008
Last Verified: September 2008