The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
Primary Purpose
Eye Burns
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
amniotic membrane transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Eye Burns focused on measuring amniotic membrane transplantation, ocular chemical burns
Eligibility 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
Sites / Locations
- Labbafinejad Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
AMT with conventional medical therapy
Medical treatment alone
Outcomes
Primary Outcome Measures
Visual acuity
Pain
Symblepharon formation
Epithelial defect healing
Corneal opacity and vascularization
Secondary Outcome Measures
Full Information
NCT ID
NCT00370812
First Posted
August 31, 2006
Last Updated
September 23, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00370812
Brief Title
The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
January 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Burns
Keywords
amniotic membrane transplantation, ocular chemical burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
AMT with conventional medical therapy
Arm Title
B
Arm Type
Active Comparator
Arm Description
Medical treatment alone
Intervention Type
Procedure
Intervention Name(s)
amniotic membrane transplantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Title
Pain
Time Frame
Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Title
Symblepharon formation
Time Frame
Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Title
Epithelial defect healing
Time Frame
Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
Title
Corneal opacity and vascularization
Time Frame
Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alireza Baradaran Raffiee, MD
Phone
+98 21 22587317
Email
labbafi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Baradaran Raffiee, MD
Organizational Affiliation
Ophthalmic Research Center of Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Labbafinejad Medical Center
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alireza Baradaran Rafiee, MD
Phone
+98 21 22587317
Email
labbafi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Alireza Baradaran Rafiee, MD
12. IPD Sharing Statement
Learn more about this trial
The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
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