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Recruiting NCT07595432

The Purpose of This Clinical Study is to Evaluate Optimized Maximum Plus for Maximum Visual Acuity (MPMVA) Refractive Technique and Its Effect on Visual Performance.

Conditions: Visual Outcome

Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Enrollment: 140
Sponsor: Hoya Surgical Optics, Inc.

Location: Peregrine Eye Laser Institute Manila

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).

Eligibility Criteria

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 eyes with oblique residual astigmatism.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07595432). StuddyBuddy aggregates publicly available trial information.