Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT01290068
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.

Detailed Description

This study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 D.

Study Timeline

• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Study Start: 2011-04
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2017-01-13
• Results First Submitted QC: 2017-01-13
• Status Verified: 2017-03
• Results First Posted: 2017-03-06
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Willing and able to understand and sign an Informed Consent;
• Willing and able to attend post-operative examinations as per protocol schedule;
• Diagnosis of bilateral, age-related cataracts;
• Planned cataract removal via phacoemulsification with implantation of an IOL;
• Available to undergo second eye surgery within 6 weeks of the first eye surgery;
• Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
• No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
• Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
• Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Previous corneal surgery and/or reshaping;
• Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
• Planned multiple procedures during cataract/IOL implantation surgery;
• Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
• Pregnant, lactating, or planning pregnancy during the course of study;
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Classified as Responders	Month 6 after second eye implantation	Distance VA and near VA were measured binocularly (both eyes together) without visual correction using ETDRS (Early Treatment of Diabetic Retinopathy Study) charts positioned at a consistent, manufactured distance. VA was measured in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR value indicating better visual acuity. A responder was defined as a participant who achieved bilateral uncorrected distance visual acuity and bilateral uncorrected near visual acuity of ≤0.1 LogMAR at the Month 6 visit.
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)	Month 6 after second eye implantation	Vision-related quality of life dimensions were evaluated using the National Eye Institute Refractive Error Quality of Life instrument (NEI-RQL 42), a self-administered questionnaire. Each dimension was scored between 0 to 100, with a higher score indicating a better vision-related Quality of Life. 5 of the dimensions were prespecified as primary.
Proportion of Participants Reporting Spectacle Independence at All Distances	Month 6 after second eye implantation	Spectacle independence at all distances; ie, where type of spectacles used/prescribed equaled 'No spectacles', was evaluated. If for the 6-month visit, spectacle type information was missing for the spectacle independence endpoint, but the subject attended this 6-month visit, subject was assumed to be spectacle independent.

Secondary Outcome Measures

Name	Time	Method
Median Total Spectacle Cost Prior to Any Reimbursement	Month 6 after second eye implantation	Total spectacle cost includes the frame, lens, and any reimbursement from national health systems or private insurance. Costs collected in pounds sterling were converted to euros.