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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0011
    • Hayashi Eye Hospital
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 101-0061
      • Tokyo Dental College Suidobashi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ReSTOR +3.0; 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; Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient; Other Names: Models SND1T3, SND1T4, SND1T5, SND1T6

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Group Manager, Surgical, Alcon Japan, Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): March 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: March 24, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (ESTIMATE): March 28, 2011

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Astigmatism; Toric; Intraocular lens; Presbyopia; Cataracts; Multifocal
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: J-10-050