NCT01323777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4 years until next milestone

Results Posted

Study results publicly available

March 6, 2017

Completed
Last Updated

July 2, 2018

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

March 24, 2011

Results QC Date

January 13, 2017

Last Update Submit

May 31, 2018

Conditions

Cataracts

Keywords

CataractsIntraocular lensMultifocalToricAstigmatismPresbyopia

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

ReSTOR +3.0

EXPERIMENTAL

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

Interventions

AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOLDEVICE

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

Also known as: Models SND1T3, SND1T4, SND1T5, SND1T6
ReSTOR +3.0

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 0.6 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tokyo Dental College Suidobashi Hospital

Chiyoda-ku, Tokyo, 101-0061, Japan

Location

Hayashi Eye Hospital

Fukuoka, 812-0011, Japan

Location

MeSH Terms

Conditions

CataractAstigmatismPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Results Point of Contact

Title
Group Manager, Surgical
Organization
Alcon Japan, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Group Manager, Surgical

    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

March 24, 2011

First Posted

March 28, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 2, 2018

Results First Posted

March 6, 2017

Record last verified: 2017-03

Locations

JP(2)