This is a prospective, multicenter, parallel groups, non-interventional, examiner masked, comparative clinical study. Patients that participated in previous Hoya studies, and patients previous implanted with Hoya non-toric monofocal IOLs (sub-study only) will be enrolled in the study. The sample size for this study is based on demonstrating the non-inferiority of the mean distance-corrected intermediate visual acuity (DCIVA) in Group 1 (Site 1) compared with Group 2 (Site 2).
Previously implanted with intraocular lens through 2 previous IOL studies;
Clear intraocular media with no clinically significant opacity, in the investigator's judgment, that would affect visual acuity;
Able to provide informed consent and complete all required study procedures.
Corrected distance visual acuity (CDVA) worse than 0.2 logMAR (or 20/32 Snellen)
Subjects with ongoing medical conditions or treatment that might impact outcomes during the study visit as determined by the investigator.
The study population includes subjects who have previously undergone intraocular lens implantation in prior studies. Subjects must have clear intraocular media, good visual acuity, and be able to provide informed consent and complete study procedures. For the exploratory sub-study, a subset of subjects with eyes from multiple prior IOL studies will be included, excluding those with oblique residual astigmatism.
Other
Prospective
Non-Interventional Study
Other interventionThis clinical investigation is non-interventional and does not involve the use of any new medical device.
Distance-corrected intermediate visual acuity
The primary objective of this study is to evaluate whether visual performance in eyes from Group 1 (Site 1) is non-inferior to eyes from Group 2 (Site 2) with respect to distance-corrected intermediate visual acuity (DCIVA), using a predefined non-inferiority margin of 0.10 logMAR.
Corrected distance visual acuity and distance-corrected near acuity
The secondary objective of the study is to evaluate whether visual performance in eyes from Group 1 (Site 1) is non-inferior to eyes from Group 2 (Site 2) with respect to corrected distance visual acuity (CDVA) and distance-corrected near acuity (DCNVA), using a non-inferiority margin of 0.10 logMAR.
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