Safety and Efficacy Study of Artificial Cornea | NCT01018888

Studies
Safety and Efficacy Study of Artificial Cornea

NCT01018888

Sponsor

Aurolab

Status

Unknown status

Last Update Posted

Jan 8, 2013Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Corneal Transplantation

Interventions

Auro KPro (Keratoprosthesis)

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Jun 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Nov 24, 2009

First Submission Date that Met QC Criteria

Nov 24, 2009

First Posted Date

Nov 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2013

Last Update Posted Date

Jan 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Keratoprosthesis	Experimental		Device: Auro KPro (Keratoprosthesis)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auro KPro (Keratoprosthesis)	Device	Front plate with optical cylinder, a back plate and a titanium ring to hold the complex together	Keratoprosthesis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mr.Karthikumar S, M.Pharm	Contact	0452-3096100	229	crd@aurolab.com
Elakiya S, M.Sc	Contact	0452-4356100	364	sicca@aravind.org

Overall Officials

Name	Affiliation	Role
Dr. Jeena Mascarenhas, MBBS, MS	Aravind Eye Hospital, Madurai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aravind Eye Hospital	Recruiting	Madurai	Tamil Nadu	625 020	India