Safety and Efficacy Study of Artificial Cornea

Corneal Transplantation Clinical Trial

— AuroKPro  

Official title:

Clinical Assessment of Auro KPro

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01018888
• Other study ID #: 1PN1010941
• Status: Recruiting
• Phase: Phase 4
• First received: November 24, 2009
• Last updated: January 7, 2013
• Start date: August 2010
• Est. completion date: July 2014

Study information

• Verified date: July 2011
• Source: Aurolab
• Contact: Mr.Karthikumar S, M.Pharm
• Phone: 0452-3096100
• Email: crd[@]aurolab.com
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Transplantation

Intervention

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

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity		1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month	No
Secondary	Retention of the device		1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month	No