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Main
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Note: This record shows only the 20 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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14 January 2013 |
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Main ID: |
NCT01018888 |
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Date of registration:
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24/11/2009 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Artificial Cornea
AuroKPro |
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Scientific title:
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Clinical Assessment of Auro KPro |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01018888 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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India
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Contacts
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Name:
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Mr. Gobinath , B.Pharm |
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Address:
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Telephone:
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0452-4356100 |
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Email:
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clinicalresearch@aravind.org |
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Affiliation:
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Name:
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Mr.Karthikumar S, M.Pharm |
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Address:
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Telephone:
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0452-3096100 |
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Email:
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crd@aurolab.com |
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Affiliation:
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Name:
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Dr. Jeena Mascarenhas, MBBS, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aravind Eye Hospital, Madurai |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age more than 20 years
- Willing to participate and review on schedule
- Multiple failed grafts with poor prognosis for regrafting
- Adequate tear film and lid function
- Projection of light in all quadrants
- Bilateral blind
Exclusion Criteria:
- Reasonable chance of success with keratoplasty
- Autoimmune disease such as Stevens Johnson Syndrome, Pemphigoid
- End stage glaucoma
- Retinal detachment
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Corneal Transplantation
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Intervention(s)
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Device: Auro KPro (Keratoprosthesis)
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Primary Outcome(s)
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Visual Acuity
[Time Frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month]
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Secondary Outcome(s)
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Retention of the device
[Time Frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month]
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Secondary ID(s)
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1PN1010941
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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