Safety and Efficacy Study of Artificial Cornea (AuroKPro)

January 7, 2013 updated by: Aurolab

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mr.Karthikumar S, M.Pharm
  • Phone Number: 229 0452-3096100
  • Email: crd@aurolab.com

Study Contact Backup

Study Locations

  • India
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625 020
        • Recruiting
        • Aravind Eye Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Jeena Mascarenhas Mascarenhas, MBBS, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurolab

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

November 24, 2009

First Submitted That Met QC Criteria

November 24, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1PN1010941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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