AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study 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® +3.0 D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace the natural lens in Japanese cataract patients.

Detailed Description
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Eligible participants completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits: Day 1-2, Day 7-14, and Day 30-60 after each implantation, and Day 120-180 and Day 330-420 after second eye implantation. The second implantation occurred within 30 days of the first.The primary eye was defined as the eye with higher astigmatism, with the other eye defined as the secondary eye. If both eyes had the same level of astigmatism, the first implanted eye was set as the primary eye.

Official Title
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Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6

Conditions
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Cataracts

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


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 0.6 decimal or better in both eyes; Preoperative astigmatism ≥ 0.75 diopter; Clear intraocular media other than cataract in study eyes; Calculated lens power and astigmatism within the available range; Pupil size greater than or equal to 6 mm after dilation; Able to undergo second eye surgery within 30 days of the first eye surgery; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: 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 0.6 decimal; Diabetic retinopathy; Previous refractive surgery, retinal detachment, corneal transplant; Glaucoma; Pregnant, nursing, or suspected of being pregnant; Currently participating in another investigational drug or device study; 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: ReSTOR +3.0<br>AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation | 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: Models SND1T3, SND1T4, SND1T5, SND1T6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Uncorrected Distance Decimal Visual Acuity | Visual acuity (VA) was tested monocularly (each eye separately) 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. | Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 | 
| Monocular Uncorrected Near Decimal VA | VA was tested monocularly unaided at a distance of 40 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. | Day 30-60, Day 120-180, Day 330-420 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataracts, Intraocular lens, Multifocal, Toric, Astigmatism, Presbyopia