Safety and Efficacy Study of Artificial Cornea (AuroKPro)

Aurolab

Status and phase: Unknown; Phase 4

Conditions: Corneal Transplantation

Treatments: Device: Auro KPro (Keratoprosthesis)

Study type: Interventional

Funder types: Other

Identifiers

NCT01018888

1PN1010941

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Keratoprosthesis

Experimental group

Treatment:

Device: Auro KPro (Keratoprosthesis)