1. Bilateral implantation of+2.5 D multifocal intraocular lens and contralateral implantation of+2.5 D and+3.0 D multifocal intraocular lenses: Clinical outcomes
- Author
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Soraya M.R. Jonker, Cristina Peris Martinez, Stefanie Schmickler, Ruth Lapid-Gortzak, Robert A. Kaufer, Javier Mendicute, Rudy M.M.A. Nuijts, Thomas Kohnen, Oogheelkunde, RS: MHeNs - R3 - Neuroscience, MUMC+: AB Refractie Chirurgie Oogheelkunde (9), MUMC+: MA Oogheelkunde (9), Other Research, and Ophthalmology
- Subjects
Adult ,Male ,medicine.medical_specialty ,Visual acuity ,Pseudophakia ,genetic structures ,medicine.medical_treatment ,Visual Acuity ,Prosthesis Design ,Ocular dominance ,Contrast Sensitivity ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Lens Implantation, Intraocular ,Surveys and Questionnaires ,Ophthalmology ,Myopia ,medicine ,Clinical endpoint ,Humans ,0601 history and archaeology ,Prospective Studies ,Prospective cohort study ,Dioptre ,Aged ,Aged, 80 and over ,Lenses, Intraocular ,Phacoemulsification ,060101 anthropology ,business.industry ,06 humanities and the arts ,Middle Aged ,Multifocal intraocular lens ,Sensory Systems ,eye diseases ,Surgery ,Patient Satisfaction ,030221 ophthalmology & optometry ,Female ,sense organs ,medicine.symptom ,business - Abstract
Purpose To assess the clinical visual outcomes of bilateral implantation of Restor +2.5 diopter (D) multifocal intraocular lenses (IOLs) and contralateral implantation of a Restor +2.5 D multifocal IOL in the dominant eye and Restor +3.0 D multifocal IOL in the fellow eye. Setting Multicenter study at 8 investigative sites. Design Prospective randomized parallel-group patient-masked 2-arm study. Methods This study comprised adults requiring bilateral cataract extraction followed by multifocal IOL implantation. The primary endpoint was corrected intermediate visual acuity (CIVA) at 60 cm, and the secondary endpoint was corrected near visual acuity (CNVA) at 40 cm. Both endpoints were measured 3 months after implantation with a noninferiority margin of Δ = 0.1 logMAR. Results In total, 103 patients completed the study (53 bilateral, 50 contralateral). At 3 months, the mean CIVA at 60 cm was 0.13 logMAR and 0.10 logMAR in the bilateral group and contralateral group, respectively (difference 0.04 logMAR), achieving noninferiority. Noninferiority was not attained for CNVA at 40 cm; mean values at 3 months for bilateral and contralateral implantation were 0.26 logMAR and 0.11 logMAR, respectively (difference 0.15 logMAR). Binocular defocus curves suggested similar performance in distance vision between the 2 groups. Treatment-emergent ocular adverse events rates were similar between the groups. Conclusion Bilateral implantation of the +2.5 D multifocal IOL resulted in similar distance as contralateral implantation of the +2.5 D multifocal IOL and +3.0 D multifocal IOL for intermediate vision (60 cm), while noninferiority was not achieved for near distances (40 cm).
- Published
- 2016
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