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

NCT01605877 | Completed Results

• 1 other identifier: J-11-037
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cataracts

Keywords

Cataracts; Intraocular lens; Multifocal; Presbyopia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• Uncorrected Decimal VA (1 m)

  Day 120-180, Day 330-420

• Distance Corrected Decimal VA (1 m)

  Day 120-180, Day 330-420

• Uncorrected Decimal VA (40 cm)

  Day 120-180, Day 330-420

• Distance Corrected Decimal VA (40 cm)

  Day 120-180, Day 330-420

• Uncorrected Decimal VA at Best Distance

  Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420

Study Arms (1)

SN6AD2

EXPERIMENTAL

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]

Interventions

AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] DEVICE

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

SN6AD2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (2)

Hayashi Eye Hospital

Fukuoka, Fukuoka, 812-0011, Japan

Location

Tokyo Dental College Suidobashi Hospital

Chiyoda-ku, Tokyo, 101-0061, Japan

Location

MeSH Terms

Conditions

Cataract; Presbyopia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Hiroshi Kodama, Group Manager
• Organization: Alcon Japan, Ltd.

81-3-6899-5000

Study Officials

• Hiroshi Kodama

  Alcon Japan, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 25, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 7, 2015
• Results First Posted: June 9, 2015

Record last verified: 2015-06

Locations

JP (2)