INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

N/ANot Yet RecruitingNCT02512432

University of California, San Diego1,000 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Keratoconus

Interventions

INTACSDEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Corneal mapping to measure corneal thickness and steepening

Corneal Topography

Time frame: 1 year

Central Contacts

Onnie Parker

CONTACT

8588224848 oparker@ucsd.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.