INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia (INTACS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Keratoconus
• Intervention / Treatment: Device: INTACS

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Onnie Parker; Phone Number: 8588224848; Email: oparker@ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: July 29, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimated): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: 150826

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes