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Treatment of PED With AMT and Autologous Serum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00238862
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : March 6, 2007
Sponsor:
Information provided by:
King Khaled Eye Specialist Hospital

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.

Condition or disease Intervention/treatment Phase
Corneal Epithelial Defect Procedure: Amniotic membrane transplantation Drug: Autologous serum/BSS 20% Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects
Study Start Date : October 2005
Study Completion Date : September 2006



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238862


Locations
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Saudi Arabia
King Khaled Eye Specialist Hospital
Riyadh, Saudi Arabia, 11462
Sponsors and Collaborators
King Khaled Eye Specialist Hospital
Investigators
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Principal Investigator: Michael D Wagoner, MD King Khaled Eye Specialist Hospital
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ClinicalTrials.gov Identifier: NCT00238862    
Other Study ID Numbers: RP0511-P
First Posted: October 14, 2005    Key Record Dates
Last Update Posted: March 6, 2007
Last Verified: March 2007
Keywords provided by King Khaled Eye Specialist Hospital:
Diabetes
Corneal transplant
Neurotrophic keratitis
Post-bacterial keratitis
Metaherpetic keratitis