Treatment of PED With AMT and Autologous Serum

November 21, 2021 updated by: King Khaled Eye Specialist Hospital

Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects

Patients with persistent corneal epithelial defects who have not responded to conventional therapy will be randomized to treatment with either amniotic membrane transplantation or autologous serum 20%. Outcome measures will be (1) presence or absence of complete re-epithelialization within 28 days and (2) retention of intact epithelium for at least 90 days.

Study Overview

Study Type

Interventional

Enrollment

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Riyadh, Saudi Arabia, 11462
        • King Khaled Eye Specialist hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Corneal epithelial defect of more than 14 days that has not responded to conventional therapy

Exclusion Criteria:

  • Under age 18
  • Pregnant/lactating females
  • Patients with hemoglobin levels < 12 mg/ml
  • Patients with limbal stem cell deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Corneal re-epithelialization (= initial success)
Persistent corneal re-epithelialization (= lasting success)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael D Wagoner, MD, King Khaled Eye Specialist hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

October 12, 2005

First Submitted That Met QC Criteria

October 12, 2005

First Posted (Estimate)

October 14, 2005

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 21, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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