Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01323777
First received: March 24, 2011
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
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 Intervention
Cataracts
Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Enrollment: 65
Study Start Date: May 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323777

Locations
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
Study Director: Group Manager, Surgical Alcon Japan, Ltd.
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01323777     History of Changes
Other Study ID Numbers: J-10-050
Study First Received: March 24, 2011
Results First Received: January 13, 2017
Last Updated: March 6, 2017

Keywords provided by Alcon Research:
Cataracts
Intraocular lens
Multifocal
Toric
Astigmatism
Presbyopia

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 24, 2017