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The Role of Amniotic Membrane Transplantation in Ocular Chemical Burns

NCT ID: NCT00370812

Last Updated: 2008-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Eye Burns

Keywords

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amniotic membrane transplantation ocular chemical burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

AMT with conventional medical therapy

Group Type ACTIVE_COMPARATOR

amniotic membrane transplantation

Intervention Type PROCEDURE

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

Medical treatment alone

Group Type ACTIVE_COMPARATOR

amniotic membrane transplantation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Alireza Baradaran Raffiee, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Research Center of Shaheed Beheshti Medical University

Locations

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Labbafinejad Medical Center

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Alireza Baradaran Raffiee, MD

Role: CONTACT

Phone: +98 21 22587317

Email: [email protected]

Facility Contacts

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Alireza Baradaran Rafiee, MD

Role: primary

Other Identifiers

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8528

Identifier Type: -

Identifier Source: org_study_id