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

Primary Purpose

Cataracts

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts focused on measuring Cataracts, Intraocular lens, Multifocal, Toric, Astigmatism, Presbyopia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tokyo Dental College Suidobashi Hospital
  • Hayashi Eye Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ReSTOR +3.0

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2011
Last Updated
May 31, 2018
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01323777
Brief Title
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan
Official Title
Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts
Keywords
Cataracts, Intraocular lens, Multifocal, Toric, Astigmatism, Presbyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReSTOR +3.0
Arm Type
Experimental
Arm Description
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Intervention Type
Device
Intervention Name(s)
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Other Intervention Name(s)
Models SND1T3, SND1T4, SND1T5, SND1T6
Intervention Description
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Primary Outcome Measure Information:
Title
Monocular Uncorrected Distance Decimal Visual Acuity
Description
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.
Time Frame
Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Title
Monocular Uncorrected Near Decimal VA
Description
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.
Time Frame
Day 30-60, Day 120-180, Day 330-420

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Group Manager, Surgical
Organizational Affiliation
Alcon Japan, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Tokyo Dental College Suidobashi Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-0061
Country
Japan
Facility Name
Hayashi Eye Hospital
City
Fukuoka
ZIP/Postal Code
812-0011
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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