PURPOSE: To compare visual acuity, accommodation, and contrast sensitivity of the AkkoLens Lumina accommodative intraocular lens (AkkoLens Clinical b.v., Breda, The Netherlands) with a standard monofocal intraocular lens (IOL). DESIGN: Randomized clinical trial. METHODS: The study enrolled 86 eyes with cataract that all required cataract surgery and IOL implantation. The study group included 61 eyes that were implanted with the Lumina. The control group included 25 eyes that were implanted with an Acrysof SA60AT (Alcon, Fort Worth, TX, USA) monofocal IOL. The distance and near visual acuities, contrast sensitivity, and accommodation were measured over a 1-year follow-up period. Accommodation was measured subjectively, using defocus curves, and objectively, with an open-field autorefractor. RESULTS:Uncorrected (UDVA) and corrected (CDVA) distance visual acuities did not differ significantly between the groups (P ≥ .21) over the 12 months. However, the uncorrected near visual acuity (UNVA) was 0.07 ± 0.08 logRAD for the Lumina group and 0.37 ± 0.19 logRAD for the control group (P < .01) and the corrected distance near visual acuity (CDNVA) was 0.11 ± 0.12 LogRAD for the Lumina group and 0.41 ± 0.15 LogRAD for the control group (P < .01). Defocus curves showed a statistically significant difference between groups for defocus ranging from -4.50 to -0.50 diopters (D) (P < .01) with significantly higher visual acuities for the Lumina group. Subjective accommodation, as determined from defocus curves, was 3.05 ± 1.06, 3.87 ± 1.27, and 5.59 ± 1.02 D for the Lumina group and 1.46 ± 0.54, 2.00 ± 0.52, and 3.67 ± 0.75 D for the control group at visual acuities of 0.10, 0.20, and 0.4 logMAR for both groups, respectively. The objective accommodation, measured by an open-field autorefractor, was 0.63 ± 0.41, 0.69 ± 0.45, 0.91 ± 0.51, and 1.27 ± 0.76 D for the Lumina group and 0.10 ± 0.15, 0.12 ± 0.15, -0.06 ± 0.09 and 0.07 ± 0.10 D for the control group at accommodation stimuli of 2.0, 2.5, 3.0, and 4.0 D, respectively. Contrast sensitivity was the same for both groups (P ≥ .26). CONCLUSIONS: The Lumina accommodative IOL effectively restores the visual function, accommodation, and contrast sensitivity after cataract surgery with no influence on the postoperative contrast sensitivity.
RCT Entities:
PURPOSE: To compare visual acuity, accommodation, and contrast sensitivity of the AkkoLens Lumina accommodative intraocular lens (AkkoLens Clinical b.v., Breda, The Netherlands) with a standard monofocal intraocular lens (IOL). DESIGN: Randomized clinical trial. METHODS: The study enrolled 86 eyes with cataract that all required cataract surgery and IOL implantation. The study group included 61 eyes that were implanted with the Lumina. The control group included 25 eyes that were implanted with an Acrysof SA60AT (Alcon, Fort Worth, TX, USA) monofocal IOL. The distance and near visual acuities, contrast sensitivity, and accommodation were measured over a 1-year follow-up period. Accommodation was measured subjectively, using defocus curves, and objectively, with an open-field autorefractor. RESULTS: Uncorrected (UDVA) and corrected (CDVA) distance visual acuities did not differ significantly between the groups (P ≥ .21) over the 12 months. However, the uncorrected near visual acuity (UNVA) was 0.07 ± 0.08 logRAD for the Lumina group and 0.37 ± 0.19 logRAD for the control group (P < .01) and the corrected distance near visual acuity (CDNVA) was 0.11 ± 0.12 LogRAD for the Lumina group and 0.41 ± 0.15 LogRAD for the control group (P < .01). Defocus curves showed a statistically significant difference between groups for defocus ranging from -4.50 to -0.50 diopters (D) (P < .01) with significantly higher visual acuities for the Lumina group. Subjective accommodation, as determined from defocus curves, was 3.05 ± 1.06, 3.87 ± 1.27, and 5.59 ± 1.02 D for the Lumina group and 1.46 ± 0.54, 2.00 ± 0.52, and 3.67 ± 0.75 D for the control group at visual acuities of 0.10, 0.20, and 0.4 logMAR for both groups, respectively. The objective accommodation, measured by an open-field autorefractor, was 0.63 ± 0.41, 0.69 ± 0.45, 0.91 ± 0.51, and 1.27 ± 0.76 D for the Lumina group and 0.10 ± 0.15, 0.12 ± 0.15, -0.06 ± 0.09 and 0.07 ± 0.10 D for the control group at accommodation stimuli of 2.0, 2.5, 3.0, and 4.0 D, respectively. Contrast sensitivity was the same for both groups (P ≥ .26). CONCLUSIONS: The Lumina accommodative IOL effectively restores the visual function, accommodation, and contrast sensitivity after cataract surgery with no influence on the postoperative contrast sensitivity.
Authors: Marcus Ang; Damien Gatinel; Dan Z Reinstein; Erik Mertens; Jorge L Alió Del Barrio; Jorge L Alió Journal: Eye (Lond) Date: 2020-07-24 Impact factor: 3.775