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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 October 2021 |
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Main ID: |
NCT00238862 |
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Date of registration:
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12/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of PED With AMT and Autologous Serum
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Scientific title:
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Efficacy of Amniotic Membrane Transplantation and Autologous Serum in Treatment of Persistent Epithelial Defects |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00238862 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Michael D Wagoner, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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King Khaled Eye Specialist Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Corneal Epithelial Defect
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Intervention(s)
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Drug: Autologous serum/BSS 20%
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Procedure: Amniotic membrane transplantation
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Primary Outcome(s)
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Corneal re-epithelialization (= initial success)
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Persistent corneal re-epithelialization (= lasting success)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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