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Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

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: NCT00710905
Recruitment Status : Terminated (Postmarket study terminated as the SN6AD3 is no longer promoted.)
First Posted : July 8, 2008
Results First Posted : November 8, 2011
Last Update Posted : November 24, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.

Condition or disease Intervention/treatment Phase
Cataract Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3 Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
Study Start Date : October 2009
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ReSTOR
Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3
Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye following cataract removal.


Outcome Measures

Primary Outcome Measures :
  1. Binocular Visual Acuity at Near, Intermediate and Distance [ Time Frame: 6 months after surgery ]
    Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

  • Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.
  • All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.
Contacts and Locations

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): NCT00710905


Locations
Canada, British Columbia
Dr John Blaylock
Abbotsford, British Columbia, Canada, V2S 5A1
Canada, Quebec
Dr Dominique Meyer
Quebec City, Quebec, Canada, G1S 1X6
Sponsors and Collaborators
Alcon Research
Investigators
Principal Investigator: John Blaylock
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00710905     History of Changes
Other Study ID Numbers: ALCONsur002.08
First Posted: July 8, 2008    Key Record Dates
Results First Posted: November 8, 2011
Last Update Posted: November 24, 2011
Last Verified: November 2011

Keywords provided by Alcon Research:
Cataract IOL ReSTOR Aspheric
Bilateral cataract

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases