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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Visual Outcome. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Philippines
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Evaluation of Visual Outcomes in LEAP, HIGH, COMP and VISN Extension Cohort
Overview
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).
Interventions
- Other Non-Interventional Study
This clinical investigation is non-interventional and does not involve the use of any new medical device.
Primary outcome measures
- Distance-corrected intermediate visual acuity [Time frame: Up to 15 days]
Secondary outcome measures (1)
- Corrected distance visual acuity and distance-corrected near acuity [Time frame: Up to 15 days]
Eligibility criteria
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:
1\. 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:
1\. Additional exclusion criteria: Pseudophakic eyes with oblique residual astigmatism.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Philippines · 1 center
- Peregrine Eye Laser Institute — Manila
Identifiers
NCT: NCT07595432 · GEMT-105-FAST