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.

NCT07595432 | Not Yet Recruiting

• 1 other identifier: GEMT-105-FAST
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Visual Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Corrected distance visual acuity and distance-corrected near acuity

  Up to 15 days

Study Arms (3)

Subjects to participate in main study only

Evaluate visual outcomes in extension cohort

Other: Non-Interventional Study

Subjects to participate in exploratory sub-study only

Evaluate visual outcomes in extension cohort

Other: Non-Interventional Study

Subjects to participate in both main and sub-study

Evaluate visual outcomes in extension cohort

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

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; Subjects to participate in exploratory sub-study only; Subjects to participate in main study only

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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:

Sponsors & Collaborators

• Hoya Surgical Optics, Inc.: lead

Study Officials

• Srividhya Vilupuru

  Hoya Surgical Optics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Srividhya Medical Monitor

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 19, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05