Safety and Efficacy Study of Artificial Cornea

Phase 4

• Conditions: Corneal Transplantation
• Interventions: Device: Auro KPro (Keratoprosthesis)

• Registration Number: NCT01018888
• Lead Sponsor: Aurolab

Brief Summary

The purpose of this study is to evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes.

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.

Study Timeline

• Study First Submitted: 2009-11-24
• Study First Submitted QC: 2009-11-24
• Study First Posted: 2009-11-25
• Study Start: 2010-08
• Status Verified: 2011-07
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08
• Primary Completion: 2014-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Keratoprosthesis	Auro KPro (Keratoprosthesis)	-

Primary Outcome Measures

Name	Time	Method
Visual Acuity	1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month

Secondary Outcome Measures

Name	Time	Method
Retention of the device	1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamil Nadu, India