Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

Tracking Information
First Submitted Date  ICMJE March 24, 2011
First Posted Date  ICMJE March 28, 2011
Results First Submitted Date  ICMJE January 13, 2017
Results First Posted Date  ICMJE March 6, 2017
Last Update Posted Date July 2, 2018
Study Start Date  ICMJE May 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01323777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan
Official Title  ICMJE Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cataracts
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: ReSTOR +3.0
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Intervention: Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2017)
65
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01323777
Other Study ID Numbers  ICMJE J-10-050
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Group Manager, Surgical Alcon Japan, Ltd.
PRS Account Alcon Research
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP