RecruitingNCT07595432

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.

Clinical Evaluation of Visual Outcomes in LEAP, HIGH, COMP and VISN Extension Cohort

Sponsor

Hoya Surgical Optics, Inc.

Enrollment

140 participants

Start Date

May 13, 2026

Study Type

OBSERVATIONAL

Conditions

Visual Outcome

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

Min Age: 21 Years

Inclusion Criteria5

Main study:
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.
Exploratory sub-study:

Exclusion Criteria4

Main study:
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.
Exploratory sub-study:

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