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

Visual Outcomes After Bilateral Surgical Cataract Phacoemulsification: AcrySof® ReSTOR IOL Implantation Compared to Monofocal IOL Implantation

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL; Device: Monofocal IOL

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 Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReSTOR +3; AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation	Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL; Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient; Other Names: SN6AD1
Experimental: ReSTOR +3 Toric; AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative corneal astigmatism, bilateral implantation, or implanted in 1 eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the other eye	Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL; Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient; Other Names: SN6AD1; Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL; Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient; Other Names: SND1T2, SND1T3, SND1T4, SND1T5
Active Comparator: Monofocal; Monofocal IOL, bilateral implantation	Device: Monofocal IOL; Monofocal IOL implanted for long-term use over the lifetime of the cataract patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Classified as Responders	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.	Month 6 after second eye implantation
Proportion of Participants Reporting Spectacle Independence at All Distances	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.	Month 6 after second eye implantation
Mean Vision-Related Quality of Life as Reported on the NEI-RQL 42 (5 Dimensions)	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.	Month 6 after second eye implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Total Spectacle Cost Prior to Any Reimbursement	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.	Month 6 after second eye implantation

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Brand Lead, Surgical, Global Medical Affairs, Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Intraocular Lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: RDG-10-269