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

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).

Study Overview

• Status: Recruiting
• Conditions: Visual Outcome
• Intervention / Treatment: Other: Non-Interventional Study

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Srividhya Medical Monitor; Phone Number: +1-909-680-3900; Email: srividhya.vilupuru@hoya.com

Study Locations

• Philippines
  • Manila, Philippines
    • Recruiting
    • Peregrine Eye Laser Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects to participate in main study only; Evaluate visual outcomes in extension cohort	Other: Non-Interventional Study; This clinical investigation is non-interventional and does not involve the use of any new medical device.
Subjects to participate in exploratory sub-study only; Evaluate visual outcomes in extension cohort	Other: Non-Interventional Study; This clinical investigation is non-interventional and does not involve the use of any new medical device.
Subjects to participate in both main and sub-study; Evaluate visual outcomes in extension cohort	Other: Non-Interventional Study; This clinical investigation is non-interventional and does not involve the use of any new medical device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 15 days

Collaborators and Investigators

• Sponsor: Hoya Surgical Optics, Inc.
• Investigators: Study Director: Srividhya Vilupuru, Hoya Surgical Optics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GEMT-105-FAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No