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The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Shaheed Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370812
First received: August 31, 2006
Last updated: September 23, 2008
Last verified: September 2008
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

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
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.

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

No publications provided

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

Keywords provided by Shaheed Beheshti Medical University:
amniotic membrane transplantation
ocular chemical burns

Additional relevant MeSH terms:
Burns
Burns, Chemical
Eye Burns
Wounds and Injuries
 Eye Injuries
Facial Injuries
Craniocerebral Trauma

ClinicalTrials.gov processed this record on May 19, 2013