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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01323777
Recruitment Status : Completed
First Posted : March 28, 2011
Results First Posted : March 6, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cataracts Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6
Study Start Date : May 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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 Name: Models SND1T3, SND1T4, SND1T5, SND1T6


Outcome Measures
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Primary Outcome Measures :
  1. Monocular Uncorrected Distance Decimal Visual Acuity [ Time Frame: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 ]
    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.

  2. Monocular Uncorrected Near Decimal VA [ Time Frame: Day 30-60, Day 120-180, Day 330-420 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323777


Locations
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Japan
Tokyo Dental College Suidobashi Hospital
Chiyoda-ku, Tokyo, Japan, 101-0061
Hayashi Eye Hospital
Fukuoka, Japan, 812-0011
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Group Manager, Surgical Alcon Japan, Ltd.
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01323777    
Other Study ID Numbers: J-10-050
First Posted: March 28, 2011    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: July 2, 2018
Last Verified: March 2017
Keywords provided by Alcon Research:
Cataracts
Intraocular lens
Multifocal
 Toric
Astigmatism
Presbyopia
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases