INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

Keratoconus Clinical Trial

— INTACS  

Official title:

INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02512432
• Other study ID #: 150826
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2025
• Est. completion date: June 2029

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: Onnie Parker
• Phone: 8588224848
• Email: oparker[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: June 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal mapping to measure corneal thickness and steepening	Corneal Topography	1 year