INTACS (Intrastromal Corneal Ring Segments) For Corneal Ectasia

University of California San Diego

Status

Not yet enrolling

Conditions

Keratoconus

Treatments

Device: INTACS

Study type

Interventional

Funder types

Other

Identifiers

NCT02512432

150826

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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