NCT02512432

INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-12-01
• Completion: 2029-06-01
• First posted: 2015-07-30
• Last updated: 2024-05-07

Regulatory

• FDA-regulated device study