- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00238862
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
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Riyadh, Saudi Arabia, 11462
- King Khaled Eye Specialist hospital
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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 |
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Corneal re-epithelialization (= initial success)
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Persistent corneal re-epithelialization (= lasting success)
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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
Keywords
Other Study ID Numbers
- RP0511-P
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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