Corneal Transplantation Clinical Trial
Official title:
Clinical Assessment of Auro KPro
The purpose of this study is to evaluate the stability of artificial cornea manufactured by Aurolab and to assess its visual outcomes.
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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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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