The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns

Phase 2

• Conditions: Eye Burns
• Interventions: Procedure: amniotic membrane transplantation

• Registration Number: NCT00370812
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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 Description

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-31
• Study First Submitted QC: 2006-08-31
• Study First Posted: 2006-09-01
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-23
• Last Update Posted: 2008-09-25
• Primary Completion: 2008-12
• Study Completion: 2009-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with chemical eye burn grade 2-4
• Burning has been occurred in 2 weeks

Exclusion Criteria

• Grade I burnings
• More than 2 weeks have passed of burning
• Follow up of the patients has been disconnected in 6 month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	amniotic membrane transplantation	AMT with conventional medical therapy
B	amniotic membrane transplantation	Medical treatment alone

Primary Outcome Measures

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

Trial Locations

Locations (1)

Labbafinejad Medical Center; 🇮🇷 Tehran, Iran, Islamic Republic of