Intacs Prescription Inserts for Keratoconus Patients
Keratoconus
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring Cornea, Keratoconus, Steep cornea
Eligibility Criteria
Inclusion Criteria:
Who have experienced a progressive deterioration in their vision, such thot they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a corneal thickness of 450 microns or greater at the proposed incision site; Who have corneal transplantation as the only remaining option to improve their functional vision.
Exclusion Criteria:
Who have abnormally thin corneas or who have a corneal thickness of 449 microns or less at the proposed incision site;
Patients with collagen vascular, autoimmune or immunodeficiency disease;
Pregnant or nursing patients;
Presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal dystrophy, that my predispose the patient to future complications;
Patients who are taking on or more of following medications: isotretinoin (Accutane); amiodarone HCL (Cordarone).
Sites / Locations
- UTSW Medical Center at DallasRecruiting
Arms of the Study
Arm 1
Other
Intacs Device
INTACS® prescription inserts are an ophthalmic medical device designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure can potentially be deferred.