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NCT Number: 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.

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).

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Key information

Conditions

Visual Outcome

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peregrine Eye Laser Institute

Manila, Philippines

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

  • Additional inclusion criteria: Pseudophakic eyes implanted with one of the IOLs in one eye from 3 previous IOL studies

Exclusion criteria

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:

  • Additional exclusion criteria: Pseudophakic eyes with oblique residual astigmatism.

Treatment and study plan

Non-Interventional Study

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Srividhya Medical Monitor

CONTACT

[email protected]

+1-909-680-3900

Sponsors and collaborators

Lead sponsor

Hoya Surgical Optics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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