CLINICAL OUTCOMES AFTER IMPLANTATION OF THE ACRYSOF® IQ RESTOR® +2.5 D MULTIFOCAL INTRAOCULAR LENS (MIOL) IN THE DOMINANT EYE AND RANDOMIZATION OF THE ACRYSOF® IQ RESTOR® +2.5 D OR +3.0 D MIOL IN THE FELLOW EYE

Completed

• Conditions: bilateral cataract; stare; 10047518

• Registration Number: NL-OMON37230
• Lead Sponsor: Alcon Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.are adult patients 21 years of age or older at the time of surgery, of either gender or any race;
2.are willing and able to understand and sign an informed consent;
3.are willing and able to attend postoperative examinations per protocol schedule;
4.require cataract extraction followed by posterior IOL implantation used as an on-label procedure in both eyes;
5.be willing to have second eye surgery within 45 days of first eye surgery;
6.are free of severe disease(s)/condition(s) listed in the *Warnings* and *Precautions* section of the AcrySof® IQ ReSTOR® +2.5 D and AcrySof® IQ ReSTOR® +3.0 D MIOL package inserts;
7.are expected to have postoperative astigmatism < 1.0 D in both eyes, measured by keratometry.

Exclusion Criteria

1.Refractive lens exchange (CDVA should be worse than 20/20);
2.Significant irregular corneal astigmatism as demonstrated by corneal topography;
3.Patients diagnosed with severe degenerative visual disorders (e.g. macular degeneration or other retinal disorders);
4.Previous corneal surgery;
5.Amblyopia;
6.Planned multiple procedures, including LRI, LASIK, etc. during surgery or the course of this study;
7.Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy);
8.History of corneal disease (e.g., herpes simplex, herpes zoster, etc.);
9.Severe diabetic retinopathy;
10.History of retinal detachment;
11.Patients who have severe conditions of acute or chronic diseases or illnesses that, per investigator*s clinical judgment, would increase the operative risk or confound the results of this investigation;
12.Any patient currently participating in another drug or device study;
13.Pregnant or planning pregnancy during course of study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Binocular distance corrected visual acuity at 60 cm at Visit 3A (90 ± 14 days).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Binocular distance corrected visual acuity at 40 cm at Visit 3A (90 ± 14 days).</p><br>