Clinical performance of KeraSoft(®) IC in irregular corneas.

PURPOSE: This study evaluated the clinical performance of KeraSoft(®) IC (KIC) soft contact lenses in subjects with irregular corneas.

PATIENTS AND

METHODS

This was a 12-month, prospective, open-label, observational study, which enrolled 43 subjects who were 18 years of age or older with irregular corneas. Subjects were fit according to the KIC Fitting Manual (kerasoftic.com). After achieving best fit according to the fitting manual, lenses were assessed for comfort, vision, centration, rotation, and movement. Subjects were instructed to wear their lenses between 8 and 16 hours each day. Assessments at the exit visit included logMAR visual acuity with high and low contrast, spherocylindrical overrefraction, slit-lamp findings, adverse events, and subjective outcomes.

RESULTS

The average base curve was 8.17±0.32 mm (n=70 eyes), and the average diameter dispensed was 14.53±0.12 mm (n=70 eyes). From the baseline to 12 months, there was statistically significant improvement in logMAR visual acuity with high contrast (P=0.038), but no significant difference in low-contrast visual acuity was observed (P>0.05). Slit-lamp findings were ≤ grade 1 for the majority of subjects (89%). Two nonserious adverse events were reported for two of the 84 enrolled eyes (two subjects). At 12 months, subjects reported improvements from habitual baseline for comfort and vision, both upon insertion and just before removal of lenses.

CONCLUSION

Clinical outcomes at 12 months showed good visual, safety, and subjective outcomes for subjects with corneal irregularities who wore KeraSoft(®) IC soft contact lenses.