NCT01018888

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

January 8, 2013

Status Verified

July 1, 2011

Enrollment Period

3.8 years

First QC Date

November 24, 2009

Last Update Submit

January 7, 2013

Conditions

Corneal Transplantation

Keywords

CorneaTransplantation, CorneaKeratoplastyGrafting, Corneal

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month

Secondary Outcomes (1)

  • Retention of the device

    1st Month, 2nd Month, 3rd Month,5th Month, 7th Month, 9th Month and 12th Month

Study Arms (1)

Keratoprosthesis

EXPERIMENTAL
Device: Auro KPro (Keratoprosthesis)

Interventions

Auro KPro (Keratoprosthesis)DEVICE

Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together

Also known as: Auro KPro
Keratoprosthesis

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Reasonable chance of success with keratoplasty
  • Autoimmune disease such as Stevens Johnson Syndrome, Pemphigoid
  • End stage glaucoma
  • Retinal detachment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

RECRUITING

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Dr. Jeena Mascarenhas, MBBS, MS

    Aravind Eye Hospital, Madurai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mr.Karthikumar S, M.Pharm

CONTACT

0452-3096100crd@aurolab.com

Elakiya S, M.Sc

CONTACT

0452-4356100sicca@aravind.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

August 1, 2010

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

January 8, 2013

Record last verified: 2011-07

Locations

IN(1)