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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014