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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL
* Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
* Device: Monofocal IOL


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR +3<br>AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, bilateral implantation | Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL<br>* Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient<br>* Other names: SN6AD1;|
| Experimental: ReSTOR +3 Toric<br>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<br>* Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient<br>* Other names: SN6AD1;Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL<br>* Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient<br>* Other names: SND1T2, SND1T3, SND1T4, SND1T5;|
| Active Comparator: Monofocal<br>Monofocal IOL, bilateral implantation | Device: Monofocal IOL<br>* Monofocal IOL implanted for long-term use over the lifetime of the cataract patient<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular Lens