AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

• Registration Number: NCT01323777
• Lead Sponsor: Alcon Research

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-28
• Study Start: 2011-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Results First Submitted: 2017-01-13
• Results First Submitted QC: 2017-01-13
• Status Verified: 2017-03
• Results First Posted: 2017-03-06
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReSTOR +3.0	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation

Primary Outcome Measures

Name	Time	Method
Monocular Uncorrected Distance Decimal Visual Acuity	Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420	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.
Monocular Uncorrected Near Decimal VA	Day 30-60, Day 120-180, Day 330-420	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.

Trial Locations

Locations (2)

Tokyo Dental College Suidobashi Hospital; 🇯🇵 Chiyoda-ku, Tokyo, Japan

Hayashi Eye Hospital; 🇯🇵 Fukuoka, Japan