Safety and Efficacy Study of Artificial Cornea (AuroKPro)
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Purpose
The purpose of this study is to evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes.
| Condition | Intervention | Phase |
|---|---|---|
|
Corneal Transplantation |
Device: Auro KPro (Keratoprosthesis) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Assessment of Auro KPro |
- Visual Acuity [ Time Frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month ] [ Designated as safety issue: No ]
- Retention of the device [ Time Frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Keratoprosthesis |
Device: Auro KPro (Keratoprosthesis)
Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together
Other Name: Auro KPro
|
Detailed Description:
The keratoprosthesis, also know as an artificial cornea plays a significant role in combating corneal blindness in patients who are no longer candidates for penetrating keratoplasty.The global incidence of corneal blindness is estimated to be 6-8 million. In India there are approximately 6.8 million cases of unilateral corneal blindness and 1.3 million people with bilateral corneal pathology.
Eligible subjects after getting informed consent will be included in this study. All the subjects will have pre-operative evaluation which includes history, visual acuity, Intraocular pressure (IOP), evaluation of tear film and ultrasound A and B scan. Ocular inflammation will be controlled prior to surgery. Keratoplasty will be performed with keratoprosthesis under local anesthesia. Patients will be followed up at regular interval to assess the outcome variables.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Mr.Karthikumar S, M.Pharm | 0452-3096100 ext 229 | crd@aurolab.com |
| Contact: Elakiya S, M.Sc | 0452-4356100 ext 364 | sicca@aravind.org |
| India | |
| Aravind Eye Hospital | Recruiting |
| Madurai, Tamil Nadu, India, 625 020 | |
| Contact: Mr. Gobinath , B.Pharm 0452-4356100 ext 364 clinicalresearch@aravind.org | |
| Contact: Muthu Selvi, BA., BBE 0452-4356100 ext 364 clinicaltrials@aravind.org | |
| Principal Investigator: Dr. Jeena Mascarenhas Mascarenhas, MBBS, MS | |
| Principal Investigator: | Dr. Jeena Mascarenhas, MBBS, MS | Aravind Eye Hospital, Madurai |
More Information
No publications provided
| Responsible Party: | Aurolab |
| ClinicalTrials.gov Identifier: | NCT01018888 History of Changes |
| Other Study ID Numbers: | 1PN1010941 |
| Study First Received: | November 24, 2009 |
| Last Updated: | January 7, 2013 |
| Health Authority: | India: Ministry of Health |
Keywords provided by Aurolab:
|
Cornea Transplantation, Cornea Keratoplasty Grafting, Corneal |
ClinicalTrials.gov processed this record on May 23, 2013