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Clinical Trials/NCT00238862
NCT00238862
Completed
Not Applicable

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

King Khaled Eye Specialist Hospital1 site in 1 country180 target enrollmentOctober 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Corneal Epithelial Defect
Sponsor
King Khaled Eye Specialist Hospital
Enrollment
180
Locations
1
Primary Endpoint
Corneal re-epithelialization (= initial success)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2005
End Date
September 2006
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Corneal re-epithelialization (= initial success)

Persistent corneal re-epithelialization (= lasting success)

Study Sites (1)

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