Safety and Efficacy Study of Artificial Cornea (AuroKPro)
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| First Received Date ICMJE | November 24, 2009 | ||||||||
| Last Updated Date | January 7, 2013 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Visual Acuity [ Time Frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01018888 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Efficacy Study of Artificial Cornea | ||||||||
| Official Title ICMJE | Clinical Assessment of Auro KPro | ||||||||
| Brief Summary | The purpose of this study is to evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Corneal Transplantation | ||||||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: Keratoprosthesis
Intervention: Device: Auro KPro (Keratoprosthesis) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | July 2014 | ||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | India | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01018888 | ||||||||
| Other Study ID Numbers ICMJE | 1PN1010941 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Aurolab | ||||||||
| Study Sponsor ICMJE | Aurolab | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Aurolab | ||||||||
| Verification Date | July 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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