INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

Sponsor

University of California, San Diego (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02512432

Collaborator

(none)

1,000

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	Device: INTACS	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Keratoconus	Device: INTACS 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.

Arm

Intervention/Treatment

Other: Keratoconus

Device: INTACS

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.

Outcome Measures

Primary Outcome Measures

Corneal mapping to measure corneal thickness and steepening [1 year]
Corneal Topography

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator: Christopher Heichel, MD, University of California, San Diego, Shiley Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christopher Heichel, MD, Associate Clinical Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT02512432

Other Study ID Numbers:

150826

First Posted:

Jul 30, 2015

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Keratoconus

Study Results

No Results Posted as of May 19, 2022