Treatment of PED With AMT and Autologous Serum

This study has been completed.
Sponsor:
Information provided by:
King Khaled Eye Specialist Hospital
ClinicalTrials.gov Identifier:
NCT00238862
First received: October 12, 2005
Last updated: March 5, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention
Corneal Epithelial Defect
Procedure: Amniotic membrane transplantation
Drug: Autologous serum/BSS 20%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects

Resource links provided by NLM:


Further study details as provided by King Khaled Eye Specialist Hospital:

Primary Outcome Measures:
  • Corneal re-epithelialization (= initial success)
  • Persistent corneal re-epithelialization (= lasting success)

Estimated Enrollment: 180
Study Start Date: October 2005
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238862

Locations
Saudi Arabia
King Khaled Eye Specialist Hospital
Riyadh, Saudi Arabia, 11462
Sponsors and Collaborators
King Khaled Eye Specialist Hospital
Investigators
Principal Investigator: Michael D Wagoner, MD King Khaled Eye Specialist Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00238862     History of Changes
Other Study ID Numbers: RP0511-P
Study First Received: October 12, 2005
Last Updated: March 5, 2007
Health Authority: Saudi Arabia: Ministry of Health
KKESH: IRB Monitor

Keywords provided by King Khaled Eye Specialist Hospital:
Diabetes
Corneal transplant
Neurotrophic keratitis
Post-bacterial keratitis
Metaherpetic keratitis

ClinicalTrials.gov processed this record on April 23, 2014