Clinical performance of presbyopia correction with a multifocal corneoscleral lens

Abstract

AIM: To assess the clinical performance of a multifocal corneoscleral lens for the presbyopia correction. METHODS: A prospective clinical trial of the Onefit™ A multifocal corneoscleral lens was conducted with 40 participants with presbyopia. At 4wk of continuous wear of the corneoscleral lens, changes in the distance, intermediate, and near visual acuity (VA) were evaluated. The safety of the corneoscleral lens, central corneal thickness (CCT), corneal endothelial cell count, binocular stereopsis, tear film break-up time (BUT), corneal staining, corneal edema, corneal neovascularization (NV), and conjunctival hyperemia were examined. In addition, a subjective questionnaire addressing satisfaction (rated from 1 to 5 points) and discomfort (rated from 1 to 5 points) was administered. RESULTS: Forty participants were enrolled in this study. Six participants were excluded because of poor compliance with lens fitting (n=2) and loss to follow-up (n=4). The mean age of the participants was 53.0±4.9y. At 4wk of continuous wear of the corneoscleral lens, the best corrected far, intermediate, and near VA was 0.08±0.11, 0.10±0.12, and 0.10±0.12 logMAR, respectively. These results were significant improvements over the baseline uncorrected VA (far: P=0.004; intermediate: P=0.004; near: P=0.002). CCT, corneal endothelial cell count, binocular stereopsis, BUT, corneal staining, corneal edema, corneal NV, and conjunctival hyperemia were not significantly different between baseline and after corneoscleral lens use. The average satisfaction scores for fit sensation; corrected far, intermediate, and near VA; and ease of handling were 4.1, 3.4, 3.6, 3.5, and 3.4, respectively. The average discomfort scores for dryness, irritation, foreign body sensation, redness, fogging, and halo were 1.7, 1.8, 1.5, 1.7, 1.7, and 1.3, respectively. CONCLUSION: Far, intermediate, and near VA are improved in presbyopic patients with the multifocal corneoscleral lens compared to uncorrected baseline VA, without adverse ocular effects. This evidence supports the safety and effectiveness of presbyopia correction with multifocal corneoscleral lenses.