The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 31, 2006
CompletedFirst Posted
Study publicly available on registry
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedSeptember 25, 2008
September 1, 2008
2.4 years
August 31, 2006
September 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
A
ACTIVE COMPARATORAMT with conventional medical therapy
B
ACTIVE COMPARATORMedical treatment alone
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with chemical eye burn grade 2-4
- Burning has been occurred in 2 weeks
You may not qualify if:
- Grade I burnings
- More than 2 weeks have passed of burning
- Follow up of the patients has been disconnected in 6 month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Labbafinejad Medical Center
Tehran, Tehran Province, 16666, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alireza Baradaran Raffiee, MD
Ophthalmic Research Center of Shaheed Beheshti Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2006
First Posted
September 1, 2006
Study Start
July 1, 2006
Primary Completion
December 1, 2008
Study Completion
January 1, 2009
Last Updated
September 25, 2008
Record last verified: 2008-09