The Purpose of This Clinical Study is to Evaluate Optimized Maximum Plus for Maximum Visua
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
| Condition(s) | Visual Outcome |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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). |
| Who can participate | Inclusion Criteria: Main study: 1. Previously implanted with intraocular lens through 2 previous IOL studies; 2. Clear intraocular media with no clinically significant opacity, in the investigator's judgment, that would affect visual acuity; 3. Able to provide informed consent and complete all required study procedures. Exploratory sub-study: 1\. Additional inclusion criteria: Pseudophakic eyes implanted with one of the IOLs in one eye from 3 previous IOL studies Exclusion Criteria: Main study: 1. Corrected distance visual acuity (CDVA) worse than 0.2 logMAR (or 20/32 Snellen) 2. Subjects with ongoing medical conditions or treatment that might impact outcomes during the study visit as determined by the investigator. Exploratory sub-study: 1\. Additional exclusion criteria: Pseudophakic eye |
| Ages | 21 Years |
| Sex | All |
| Lead sponsor | Hoya Surgical Optics, Inc. |
| Locations | Manila, Philippines |
| Start date | 2026-05-13 |
| NCT ID | NCT07595432 |
| Official listing | https://clinicaltrials.gov/study/NCT07595432 |