The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Eye Burns

Treatments: Procedure: amniotic membrane transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00370812

8528

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

A

Active Comparator group

Description:

AMT with conventional medical therapy

Treatment:

Procedure: amniotic membrane transplantation

B

Active Comparator group

Description:

Medical treatment alone

Treatment:

Procedure: amniotic membrane transplantation