The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns

Eye Burns Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00370812
• Other study ID #: 8528
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 31, 2006
• Last updated: September 23, 2008
• Start date: July 2006
• Est. completion date: January 2009

Study information

• Verified date: September 2008
• Source: hahid Beheshti University of Medical Sciences
• Contact: Alireza Baradaran Raffiee, MD
• Phone: +98 21 22587317
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Burns

Intervention

Procedure:
• amniotic membrane transplantation
AMT with conventional medical therapy (group A) or medical treatment only (group B). AMT will be performed within 24h of presentation. Amniotic membrane will remain in place for 7-14 days.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Labbafinejad Medical Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity		Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year	No
Primary	Pain		Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year	No
Primary	Symblepharon formation		Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year	No
Primary	Epithelial defect healing		Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year	No
Primary	Corneal opacity and vascularization		Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year	No