AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] in Japan

Study Overview
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Brief Summary
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The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] in Japanese cataract patients.

Detailed Description
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Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 8 postoperative visits (each eye examined at Day 1-2, Day 7-14, and Day 30-60, with binocular visits at Day 120-180 and Day 330-420 after the second implantation). The second implantation occurred within 30 days of the first.

Official Title
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Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Intraocular Lens 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]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign informed consent; Diagnosed with bilateral cataracts; Planned cataract removal by phacoemulsification; Potential postoperative visual acuity of 0.5 decimal or better in both eyes; Preoperative astigmatism ≤ 1.5 diopter; Clear intraocular media other than cataract in study eyes; Calculated lens power within the available range; Able to undergo second eye surgery within 30 days of the first eye surgery; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Significant irregular corneal aberration as demonstrated by corneal topography; Any inflammation or edema (swelling) of the cornea; Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.5 decimal; Diabetic retinopathy; Previous refractive surgery, retinal detachment, corneal transplant; Glaucoma; Pregnancy; Currently participating in another investigational drug or device study; Exclusion criteria during surgery; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SN6AD2<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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Decimal VA (5 m) | Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | 
| Uncorrected Decimal VA (50 cm) | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | 
| Best Corrected Decimal VA (5 m) | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | 
| Best Corrected Decimal VA (50 cm) | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | 
| Distance-Corrected Decimal VA (50 cm) | VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Decimal VA (1 m) | VA was tested binocularly unaided at a distance of 1 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Day 120-180, Day 330-420 | 
| Distance Corrected Decimal VA (1 m) | VA was tested binocularly using a chart. Distance-corrected VA at 1 m is the VA at 1 m measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Day 120-180, Day 330-420 | 
| Uncorrected Decimal VA (40 cm) | VA was tested binocularly unaided at a distance of 40 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Day 120-180, Day 330-420 | 
| Distance Corrected Decimal VA (40 cm) | VA was tested binocularly using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Day 120-180, Day 330-420 | 
| Uncorrected Decimal VA at Best Distance | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart at the distance of best near vision (cm) as decided by the participant. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | 
| Mean Best Distance (cm) for Uncorrected Decimal Near VA | VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided using a chart. The participant indicated the distance (cm) at which best near vision was attained. | Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | 
| Mean Best Distance (cm) for Distance Corrected Decimal Near VA | VA was tested monocularly at Day 1-2, Day 7-14, Day 30-60, Day 120-180, and Day 330-420 and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction using a chart. The participant indicated the distance (cm) at which best near vision was attained. | Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | 
| Best Corrected Far (3 m) Contrast Sensitivity | Far contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 3 m using the Vector Vision CSV 1000 illuminated box (one site) and the Vision Contrast Test System (other site). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). For CSV 1000, contrast sensitivity was not measured at spatial frequency 1.5 cpd because there was no option for this frequency. Raw scores were transformed to logMar (logarithm of the minimum angle of resolution) units. A higher numeric value represents better contrast sensitivity. | Day 120-180 from second eye implantation | 
| Best Corrected Near (46 cm) Contrast Sensitivity | Near contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 46 cm using the Functional Acuity Contrast Test (FACT). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). Raw scores were transformed to logMar units. A higher numeric value represents better contrast sensitivity. | Day 120-180 from second eye implantation | 
| Mean Defocus Decimal VA (5 m) | Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction at a distance of 5 m using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Day 120-180 from second eye implantation | 
| Percentage of Participants With Positive Response, Stereoscopic Vision Test | Stereopsis (the ability to perceive depth and 3-dimensional structure) was assessed binocularly under well-lit conditions at best distance using the Stereo Optical Company, Inc., Original Stereo Fly Test and polarized viewers. The participant was shown a series of symbols, with a positive response defined as correct identification of the 3-dimensional symbol. Responses were recorded for 3 symbols: Fly (easiest to perceive), animal, and circle (hardest to perceive). | Day 120-180 from second eye implantation | 
| Percentage of Participants With Positive Response, Quality of Life Questions | The participant completed a questionnaire, indicating (yes/no) if he/she experienced visual difficulty in every-day activities while not wearing spectacles. A positive response was defined as, Yes=visual difficulty. | 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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Cataracts, Intraocular lens, Multifocal, Presbyopia