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AuroKPro: Safety and Efficacy Study of Artificial Cornea

Sponsor
Aurolab (Other)
Overall Status
Unknown status
CT.gov ID
NCT01018888
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
47
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Auro KPro (Keratoprosthesis)
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Assessment of Auro KPro
Study Start Date :
Aug 1, 2010
Anticipated Primary Completion Date :
Jun 1, 2014
Anticipated Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Keratoprosthesis

Device: Auro KPro (Keratoprosthesis)
Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together
Other Names:
  • Auro KPro

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Acuity [1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month]

    Secondary Outcome Measures

    1. Retention of the device [1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aravind Eye Hospital Madurai Tamil Nadu India 625 020

    Sponsors and Collaborators

    • Aurolab

    Investigators

    • Principal Investigator: Dr. Jeena Mascarenhas, MBBS, MS, Aravind Eye Hospital, Madurai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aurolab
    ClinicalTrials.gov Identifier:
    NCT01018888
    Other Study ID Numbers:
    • 1PN1010941
    First Posted:
    Nov 25, 2009
    Last Update Posted:
    Jan 8, 2013
    Last Verified:
    Jul 1, 2011
    Keywords provided by Aurolab
    Cornea
    Transplantation, Cornea
    Keratoplasty
    Grafting, Corneal

    Study Results

    No Results Posted as of Jan 8, 2013