NCT01018888

Safety and Efficacy Study of Artificial Cornea

Clinical Assessment of Auro KPro

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Aurolab · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Corneal Transplantation

Interventions

Type	Name	Description
DEVICE	Auro KPro (Keratoprosthesis)	Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-06-01
• Completion: 2014-07-01
• First posted: 2009-11-25
• Last updated: 2013-01-08

Locations

1 site across 1 country: India