Visual OutcomeNCT07595432
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.
An observational study of Visual Outcome, run by Hoya Surgical Optics, Inc. at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Visual Outcome
- What is being tested?
- Non-Interventional Study
- How many people
- 140 participants
- Where
- 1 sitePhilippines
- Study dates
- 13 May 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- 1. Additional inclusion criteria: Pseudophakic eyes implanted with one of the IOLs in one eye from 3 previous IOL studies
Who cannot join
- 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:
- 1. Additional exclusion criteria: Pseudophakic eyes with oblique residual astigmatism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philippines1 site, 1 recruiting
- Recruiting
Peregrine Eye Laser Institute
Manila
About this study
Official title: 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).
- Conditions
- Visual Outcome
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
This clinical investigation is non-interventional and does not involve the use of any new medical device.
| Study group | Role | What they receive |
|---|---|---|
| Subjects to participate in main study only | Evaluate visual outcomes in extension cohort Receives: Other: Non-Interventional Study | |
| Subjects to participate in exploratory sub-study only | Evaluate visual outcomes in extension cohort Receives: Other: Non-Interventional Study | |
| Subjects to participate in both main and sub-study | Evaluate visual outcomes in extension cohort Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 days
Secondary outcomes (1)
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.
Measured: Up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start13 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoya Surgical Optics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Srividhya Vilupuru, Study director, Hoya Surgical Optics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595432
- Sponsor's protocol ID
- GEMT-105-FAST
- Status last verified
- Jun 2026
- First submitted
- 8 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Visual Outcomes in LEAP, HIGH, COMP and VISN Extension Cohort
- ClinicalTrials.gov ID
- NCT07595432
- Acronym / sponsor ID
- GEMT-105-FAST
- Conditions
- Visual Outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hoya Surgical Optics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects to participate in main study only | – | Other: Non-Interventional StudyEvaluate visual outcomes in extension cohort |
| Subjects to participate in exploratory sub-study only | – | Other: Non-Interventional StudyEvaluate visual outcomes in extension cohort |
| Subjects to participate in both main and sub-study | – | Other: Non-Interventional StudyEvaluate visual outcomes in extension cohort |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- 1. Additional inclusion criteria: Pseudophakic eyes implanted with one of the IOLs in one eye from 3 previous IOL studies
Key exclusion criteria (5 listed)
- 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.
- 1. Additional exclusion criteria: Pseudophakic eyes with oblique residual astigmatism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyThis clinical investigation is non-interventional and does not involve the use of any new medical device. | Other | Subjects to participate in both main and sub-study, Subjects to participate in exploratory sub-study only, Subjects to participate in main study only |
Primary outcome
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.
1 secondary outcome
Corrected distance visual acuity and distance-corrected near acuity
Time frame: Up to 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Srividhya Vilupuru study director
Hoya Surgical Optics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Outcome, run by Hoya Surgical Optics, Inc. at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Srividhya Medical Monitor (+1-909-680-3900, srividhya.vilupuru@hoya.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance-corrected intermediate visual acuity (time frame: Up to 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.