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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.
Conditions: Visual Outcome
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: No
Enrollment: 140
Sponsor: Hoya Surgical Optics, Inc.
Location: Peregrine Eye Laser Institute Manila
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).
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07595432). StuddyBuddy aggregates publicly available trial information.