RESUMO
PURPOSE: Several research studies on high Dk soft contact lens materials have been published, but little has been reported from practical clinical experience with these new materials. This study reports in-practice clinical experience with the lotrafilcon A fluorosilicone hydrogel material from a 6-month study in Spain. METHODS: Eighty-five patients were dispensed lotrafilcon A lenses (Focuse NIGHT & DAY [CIBA Vision Corporation]) for monthly replacement by 13 investigators from eight practices. The recommended wear schedule was daily wear for the first week and then up to 6-night extended wear through the first month and up to 30-night extended wear through 6 months. Follow-up visits were at 1 week, 1 month, 3 months, and 6 months. Clinical and patient subjective data were collected at each visit. RESULTS: Among patients who continued in the study at each visit, Snellen visual acuity (VA) of 20/25 or better was achieved by at least 96% of all eyes at all visits; lens surfaces assessments for front surface deposits, front surface wetting, and back surface debris averaged less than grade 1 (0-4 scale) for all lenses at all visits; biomicroscopy grades averaged well below grade 1 (0-4 scale) for all eyes at all visits; acceptable or optimal fit was assessed for 97% or more of all lenses at all visits. These patients rated the average overall comfort, vision, and handling above 9 (0-10 scale) at 6 months and 98% reported satisfaction with the lenses at 6 months. Eighty-two percent of patients dispensed completed the study. Seven patients were discontinued because of fit, and seven were discontinued because of positive biomicroscopy signs. CONCLUSIONS: The lotrafilcon A lens performed well clinically and it was accepted well by patients, with most practitioners recommending and most patients wearing it for up to 30 nights extended wear. Practitioners should be attentive to fit and discomfort complaints at dispensing and follow-up and may want to recommend lubricating or rewetting drops for those patients with dryness symptoms.
