Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of an investigational multifocal intraocular lens (IOL) to an FDA-approved monofocal IOL.

Detailed Description
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Participants 21 years and older in need of cataract extraction were consented and randomized in a 1:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] or the AcrySof® IQ Monofocal IOL Model SN60WF in both eyes. Each participant completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 7 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60, and monocular and binocular testing at Day 120-180 following the second implantation. The first eye to be implanted was considered the primary eye. The second eye was implanted 7 and 30 days of the first. If the first eye was not implanted during surgery, the second eye was not eligible. If the second eye was not implanted during surgery, only the first eye was followed.

Official Title
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Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2

Conditions
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Cataracts

Intervention / Treatment
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* Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
* Device: AcrySof® IQ Monofocal IOL Model SN60WF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of bilateral cataracts Willing and able to complete all required postoperative visits Calculated lens power within the available supply range Planned cataract removal by phacoemulsification Potential postoperative visual acuity of 0.2 logMAR or better in both eyes Preoperative astigmatism less than 1.0 diopter Clear intraocular media other than cataract in study eyes Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR Able to undergo second eye surgery between 7 days and 30 days of the first eye surgery Other protocol-defined inclusion criteria may apply Exclusion Criteria: Previous refractive surgery Inflammation or edema of the cornea Optic nerve atrophy Pregnancy Current participation in another investigational drug or device 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multifocal IOL<br>AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation | Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]<br>* Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient<br>|
| Active Comparator: Monofocal IOL<br>AcrySof® IQ Monofocal IOL Model SN60WF, bilateral implantation | Device: AcrySof® IQ Monofocal IOL Model SN60WF<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 |
| --- | --- | --- |
| Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180 | Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye. | Day 120-180 from second eye implantation | 
| Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 | Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL. | Day 0 first operative eye visit, up to Day 120-180 from second eye implantation | 
| Photopic Contrast Sensitivity Without Glare at Day 120-180 | Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | Day 120-180 from second eye implantation | 
| Photopic Contrast Sensitivity With Glare at Day 120-180 | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | Day 120-180 from second eye implantation | 
| Mesopic Contrast Sensitivity Without Glare at Day 120-180 | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | Day 120-180 from second eye implantation | 
| Mesopic Contrast Sensitivity With Glare at Day 120-180 | Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity. | Day 120-180 from second eye implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180 | VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye. | Day 120-180 from second eye implantation | 
| Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180 | VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye. | Day 120-180 from second eye implantation | 
| Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses overall? | Day 120-180 from second eye implantation | 
| Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 | Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses for seeing objects up close? | Day 120-180 from second eye implantation | 

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