Safety and Efficacy Study of Artificial Cornea (AuroKPro)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Aurolab.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT01018888
First received: November 24, 2009
Last updated: January 7, 2013
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Corneal Transplantation
Device: Auro KPro (Keratoprosthesis)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of Auro KPro

Resource links provided by NLM:


Further study details as provided by Aurolab:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retention of the device [ Time Frame: 1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018888

Contacts
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

Locations
India
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
Aurolab
Investigators
Principal Investigator: Dr. Jeena Mascarenhas, MBBS, MS Aravind Eye Hospital, Madurai
  More Information

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01018888     History of Changes
Other Study ID Numbers: 1PN1010941
Study First Received: November 24, 2009
Last Updated: January 7, 2013
Health Authority: India: Ministry of Health

Keywords provided by Aurolab:
Cornea
Transplantation, Cornea
Keratoplasty
Grafting, Corneal

ClinicalTrials.gov processed this record on August 18, 2014