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.

Hoya Surgical Optics, Inc.140 enrolled

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).

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Visual Outcome

Interventions

Non-Interventional StudyOTHER

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Up to 15 days

Secondary Outcomes

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.