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Safety and Efficacy Study of Artificial Cornea (AuroKPro)

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ClinicalTrials.gov Identifier: NCT01018888
Recruitment Status : Unknown
Verified July 2011 by Aurolab.
Recruitment status was:  Recruiting
First Posted : November 25, 2009
Last Update Posted : January 8, 2013
Information provided by (Responsible Party):

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
Corneal Transplantation 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Assessment of Auro KPro
Study Start Date : August 2010
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Auro KPro

Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month ]

Secondary Outcome Measures :
  1. Retention of the device [ Time Frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01018888

Contact: Mr.Karthikumar S, M.Pharm 0452-3096100 ext 229 crd@aurolab.com
Contact: Elakiya S, M.Sc 0452-4356100 ext 364 sicca@aravind.org

Aravind Eye Hospital Recruiting
Madurai, Tamil Nadu, India, 625 020
Contact: Mr. Gobinath , B.Pharm    0452-4356100 ext 364    clinicalresearch@aravind.org   
Contact: Muthu Selvi, BA., BBE    0452-4356100 ext 364    clinicaltrials@aravind.org   
Principal Investigator: Dr. Jeena Mascarenhas Mascarenhas, MBBS, MS         
Sponsors and Collaborators
Principal Investigator: Dr. Jeena Mascarenhas, MBBS, MS Aravind Eye Hospital, Madurai

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01018888     History of Changes
Other Study ID Numbers: 1PN1010941
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: July 2011

Keywords provided by Aurolab:
Transplantation, Cornea
Grafting, Corneal