Safety and Efficacy of Scleral Lenses for Keratoconus.

Abstract

SIGNIFICANCEThis study affirms the long-term safety and efficacy of scleral contact lens use in patients with keratoconus.PURPOSEThis study aimed to evaluate the safety and efficacy of contemporary scleral contact lenses in the visual rehabilitation of the keratoconic population.METHODSA 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.RESULTSA 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 reeducation (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 from a 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.CONCLUSIONSConsistent with other groups, our study demonstrates excellent safety and efficacy of scleral contact lenses in subjects with keratoconus.