INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia
NCT02512432 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000
Last updated 2024-05-07
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.
Conditions
- Keratoconus
Interventions
- 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.
Sponsors & Collaborators
-
University of California, San Diego
lead OTHER
Principal Investigators
-
Christopher Heichel, MD · University of California, San Diego, Shiley Eye Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-12-31
- Primary Completion
- 2028-12-31
- Completion
- 2029-06-30
- FDA Device
- Yes
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