Safety and Efficacy of Scleral Lenses for Keratoconus

SIGNIFICANCE: This study affirms the long-term safety and efficacy of scleral contact lens use in patients with keratoconus. PURPOSE: This study aimed to evaluate the safety and efficacy of contemporary scleral contact lenses in the visual rehabilitation of the keratoconic population. METHODS: A retrospective study of keratoconic subjects examined between 2013 and 2018 was conducted. Subjects were included regardless of age, sex, pre-existing morbidity, or scleral lens design. Only eyes fit successfully with scleral contact lenses for >= 1 year were included. Exclusion criteria were prior corneal surgery, dystrophy, degeneration, and trauma. RESULTS: A total of 157 eyes of 86 subjects met the study criteria. The mean Keratoconus Severity Score at initial fitting was 3.6 +/- 1.0. Lenses were gas-permeable and nonfenestrated, with a mean overall diameter of 15.8 +/- 0.6 mm and 70.1% toric scleral periphery. Physiological adverse events occurred in 9.6% of eyes, including microbial keratitis (0.6%), phlyctenulosis (0.6%), corneal abrasion (1.3%), contact lens-induced acute red eye (1.3%), corneal infiltrative events (1.3%), pingueculitis (1.3%), and hydrops (3.2%). Lens-related adverse events were documented in 55.4% of eyes. Adverse events related to surface issues included poor wetting in 1.9%, handling in 3.8%, reservoir fogging in 7.0%, lens intolerance in 7.6%, deposit in 8.9%, and broken lenses in 26.1% of eyes. The most common management strategies involved refits (54.0% of interventions), patient re-education (29.5%), medical treatment (5.5%), surgical referral (6.8%), adjustment to wear time (2.5%), surface treatment (1.2%), and lens replacement (0.6%). Best-corrected distance logMAR visual acuity improved significantly froma mean of 0.50 in spectacles to a mean of 0.08 in scleral lenses (P <.0001). During the study period, 14.6% of eyes lost best-corrected scleral lens visual acuity, all from keratoconus progression. CONCLUSIONS: Consistent with other groups, our study demonstrates excellent safety and efficacy of scleral contact lenses in subjects with keratoconus.