Safety and Efficacy Study of Artificial Cornea

Clinical Assessment of Auro KPro

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018888

Acronym

AuroKPro

Enrollment

Registered

2009-11-25

Start date

2010-08-31

Completion date

2014-07-31

Last updated

2013-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Transplantation

Keywords

Cornea, Transplantation, Cornea, Keratoplasty, Grafting, Corneal

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.

Interventions

DEVICEAuro KPro (Keratoprosthesis)

Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Primary ContactMr.Karthikumar S, M.Pharm

crd@aurolab.com0452-3096100

Backup ContactElakiya S, M.Sc

sicca@aravind.org0452-4356100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026