Intacs Prescription Inserts for Keratoconus Patients

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · May 12, 2014

Keywords

ClinConnect Summary

This clinical trial is studying the use of INTACS prescription inserts for patients with keratoconus, a condition that causes progressive vision loss due to a thinning of the cornea, which is the clear front part of the eye. INTACS are small, clear segments made from a special material that are inserted into the eye to help improve vision. The trial is looking for individuals who are at least 21 years old, have experienced worsening vision that can no longer be corrected with glasses or contact lenses, and have certain eye characteristics that make them suitable for this treatment.

To participate in the trial, potential candidates must have a clear central cornea and a corneal thickness of 450 microns or more at the site of the insertion. Those with very thin corneas, certain autoimmune diseases, or who are pregnant or nursing are not eligible. If you choose to take part in this study, you can expect to receive the INTACS inserts and be monitored for their effectiveness in improving your vision. This trial is currently recruiting participants, and it offers a potential alternative for those who may have exhausted other options for vision correction.

Gender

ALL

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).