The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A AMT with conventional medical therapy |
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.
|
| Active Comparator: B Medical treatment alone |
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.
|
Outcome Measures
Primary Outcome Measures
- Visual acuity [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]
- Epithelial defect healing [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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Labbafinejad Medical Center | Tehran | Iran, Islamic Republic of | 16666 |
Sponsors and Collaborators
- Shahid Beheshti University of Medical Sciences
Investigators
- Principal Investigator: Alireza Baradaran Raffiee, MD, Ophthalmic Research Center of Shaheed Beheshti Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8528