Abstract
Abstract: :
Purpose:To assess the safety of INTACS prescription inserts when implanted into keratoconic eyes. Methods:A retrospective analysis integrating the safety data related to INTACS implantation in patients with keratoconus, a disease that leads to some 2,500 corneal transplants in the U.S. each year. The results from three studies were intregrated for this analysis. A total of 164 eyes were followed for 12 to 24 months following implantation. Outcome measures included safety assessments, as well as changes in UCVA, BCVA, MRSE, keratometry readings, pachymetry, visual symptoms and quality of vision. Results:Overall, 72% of patients gained two or more lines (some as much as 5 lines) of UCVA, and 48% gained two or more lines of BCVA. For the majority of patients vision was improved, and possibly, the need for a corneal transplant was delayed or eliminated. Post–operative complications occurred in a total of 8 eyes or 4.9% of the patients, and included non–infectious lamellar keratitis, superficial tunnel dissection, transient inflammatory reaction, visual symptoms and neovascularization. Intacs prescription inserts were explanted in 14 eyes or 8.5% due to visual symptoms, segment migration, superficial placement, astigmatism or topographic irregularity. Following explantation, eyes that were indicated for PKP underwent successful corneal transplants. Conclusions:INTACS prescription inserts appear to be safe for implantation into patients with keratoconus. Patients who underwent INTACS inserts explantation were able to have PKP performed.
Keywords: keratoconus • clinical (human) or epidemiologic studies: outcomes/complications • contact lens