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

NCT ID: NCT01323777

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-03-31

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.

Conditions

Cataracts

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ReSTOR +3.0

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

Group Type: EXPERIMENTAL

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Intervention Type: DEVICE

Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Interventions

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient

Intervention Type: DEVICE

Other Intervention Names

Models SND1T3, SND1T4, SND1T5, SND1T6

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Group Manager, Surgical

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Locations

Tokyo Dental College Suidobashi Hospital

Chiyoda-ku, Tokyo, Japan

Hayashi Eye Hospital

Fukuoka, , Japan

Countries

Japan

Other Identifiers

J-10-050

Identifier Type: -

Identifier Source: org_study_id