Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370812
Status:
UNKNOWN
Last Update Posted:
2008-09-25
First Post:
2006-08-31
Brief Title:
The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Shahid Beheshti University of Medical Sciences
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None