The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns - Full Text View

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00370812

Purpose

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	Intervention	Phase
Eye Burns	Procedure: amniotic membrane transplantation	Phase II Phase III

MedlinePlus related topics: Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

Visual acuity [ Time Frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year ] [ Designated as safety issue: No ]
Pain [ Time Frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year ] [ Designated as safety issue: No ]
Symblepharon formation [ Time Frame: Days 1, 3, 7, 10, 14, 21, 28 and then every 2weeks until 3 months and monthly until 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	July 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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.
B: Active Comparator 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.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370812

Contacts

Contact: Alireza Baradaran Raffiee, MD

+98 21 22587317

labbafi@hotmail.com

Locations

Iran, Islamic Republic of
Labbafinejad Medical Center	Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Alireza Baradaran Rafiee, MD +98 21 22587317 labbafi@hotmail.com
Principal Investigator: Alireza Baradaran Rafiee, MD

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Alireza Baradaran Raffiee, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

Study ID Numbers:	8528
Study First Received:	August 31, 2006
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00370812
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

amniotic membrane transplantation
ocular chemical burns

Study placed in the following topic categories:

Craniocerebral Trauma
Burns
Facial Injuries
Facies
Eye Injuries

Wounds and Injuries
Disorders of Environmental Origin
Burns, Chemical
Eye Burns

ClinicalTrials.gov processed this record on January 16, 2009