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.

June 3, 2026 updated by: Hoya Surgical Optics, Inc.

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
Up to 15 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoya Surgical Optics, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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