INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

NCT ID: NCT02512432

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-06-30

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.

Conditions

Keratoconus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Keratoconus

Group Type: OTHER

INTACS

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Christopher Heichel, MD

Associate Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Heichel, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego, Shiley Eye Institute

Central Contacts

Onnie Parker

Role: CONTACT

oparker@ucsd.edu

8588224848

Other Identifiers

150826

Identifier Type: -

Identifier Source: org_study_id