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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07595432

Enrollment

140

Registered

2026-05-19

Start date

2026-05-13

Completion date

2026-11-30

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Outcome

Brief 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).

Interventions

OTHERNon-Interventional Study

This clinical investigation is non-interventional and does not involve the use of any new medical device.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Distance-corrected intermediate visual acuity	Up to 15 days	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.

Secondary

Measure	Time frame	Description
Corrected distance visual acuity and distance-corrected near acuity	Up to 15 days	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.

Countries

Philippines

Contacts

CONTACTSrividhya Medical Monitor

srividhya.vilupuru@hoya.com+1-909-680-3900

STUDY_DIRECTORSrividhya Vilupuru

Hoya Surgical Optics, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026