INTACS (Intrastromal Corneal Ring Segments) For Corneal E... | NCT02512432

Studies
INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

NCT02512432

Sponsor

University of California, San Diego

Status

Not yet recruiting

Last Update Posted

May 7, 2024Actual

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Keratoconus

Interventions

INTACS

Countries

Not provided

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

May 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2025Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Jun 2029Estimated

First Submitted Date

Jul 29, 2015

First Submission Date that Met QC Criteria

Jul 29, 2015

First Posted Date

Jul 30, 2015Estimated

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

May 6, 2024

Last Update Posted Date

May 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christopher Heichel, MD, Associate Clinical Professor, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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

To join established study put on by Addition Technologies, Inc. in the surgical implantation of asymmetrical INTACS segments to treat myopia and astigmatism in patients with keratoconus.

Detailed Description

Use of asymmetrical corneal inserts to reduce or eliminate myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for corneal transplantation may potentially be deferred.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Keratoconus	Other		Device: INTACS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INTACS	Device	asymmetrical corneal inserts to reduce, or eliminate myopia and astigmatism in patients with keratoconus to decrease dependence on contact lenses and spectacle correction, while potentially deferring need for corneal transplantation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Corneal mapping to measure corneal thickness and steepening	Corneal Topography	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

21 years of age, or older
have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
have clear central corneas
have a corneal thickness of 450 microns or greater at the proposed incision site
have corneal transplantation as the only remaining option to improve their visual function

Exclusion Criteria:

under 21 years of age
have not experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with contact lenses, or spectacles.
do not have clear central corneas
do not have a corneal thickness of 450 microns or greater at the proposed incision site
do not have corneal transplantation as the only remaining option to improve their visual function

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Onnie Parker	Contact	8588224848		oparker@ucsd.edu

Overall Officials

Name	Affiliation	Role
Christopher Heichel, MD	University of California, San Diego, Shiley Eye Institute	Principal Investigator

Locations

Not provided

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases