INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

Not Applicable

Not yet recruiting

• Conditions: Keratoconus
• Interventions: Device: INTACS

• Registration Number: NCT02512432
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Study Start: 2025-12
• Primary Completion: 2028-12
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Keratoconus	INTACS	-

Primary Outcome Measures

Name	Time	Method
Corneal mapping to measure corneal thickness and steepening	1 year	Corneal Topography