Keratoconus
Conditions
Brief 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.
Interventions
DEVICEINTACS
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
University of California, San Diego
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal mapping to measure corneal thickness and steepening | 1 year | Corneal Topography |
Contacts
Primary ContactOnnie Parker
Outcome results
None listed