Visual Function and Subjective Perception of Vision following bilateral implantation of monofocal and multifocal intraocular lenses: A Randomised Controlled Trial

Abstract

PURPOSE: To examine monocular and binocular visual function and patient-reported outcomes after implantation of multifocal IOLs (mIOLs) or monofocal IOLs, using a rigorous series of clinical assessments. SETTING: BMI Southend Hospital, United Kingdom. DESIGN: Prospective, randomized, double-masked clinical trial. METHODS: One hundred patients were randomized for bilateral implantation of either a Bi-Flex 677MY mIOL or a Bi-Flex 677AB IOL and were assessed at 3 to 6 months (V1) and 12 to 18 months (V2). Primary outcomes included distance, intermediate, and near logarithm of the minimum angle of resolution (logMAR) visual acuities (VAs) and defocus curve profile assessment. Secondary outcomes included reading speed, contrast sensitivity (CS), and the subjective perception of quality of vision. RESULTS: Forty-seven subjects with monofocal IOL and 43 mIOL subjects completed the study. Uncorrected (mIOL: 0.10 ± 0.09 logMAR; IOL: 0.09 ± 0.11 logMAR) and corrected (mIOL: 0.04 ± 0.06 logMAR; IOL: 0.01 ± 0.07 logMAR) distance VAs were comparable (P > .05). Uncorrected near VA (mIOL: 0.23 ± 0.13 logMAR; IOL: 0.55 ± 0.20 logMAR, P < .001) and distance-corrected near VA (mIOL: 0.24 ± 0.13 logMAR; IOL: 0.54 ± 0.17 logMAR, P < .001) were significantly improved with mIOLs. There was no significant difference in distance-corrected intermediate VA (mIOL: 0.38 ± 0.13 logMAR; IOL: 0.39 ± 0.13 logMAR, P = .431). Defocus curves demonstrated an increased range-of-focus among mIOLs (mIOL: 4.14 ± 1.10 diopter [D]; IOL: 2.57 ± 0.77 D). Pelli-Robson CS was different at V1 (P < .001) but similar by V2 (P = .059). Overall satisfaction was high (>90%) in both groups for distance tasks whereas significantly different for near tasks (mIOL, 18.45 ± 16.53 logUnits; IOL, 55.59 ± 22.52 logUnits). CONCLUSIONS: Uncorrected near visual acuity was demonstrably better with mIOLs and there was greater subjective satisfaction with quality of near vision. Halos reported by the mIOL group were significant compared with the IOL group but did not show an adverse effect on overall satisfaction.