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Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)

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: NCT00759668
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : January 26, 2011
Last Update Posted : January 26, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

The purpose of the study is:

  • to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
  • to assess patient satisfaction before and after implant

Condition or disease Intervention/treatment
Cataract Device: Acrysof Natural ReSTOR SN60D3 Device: Acrysof Natural Monofocal SN60AT

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SN60D3
AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3
Device: Acrysof Natural ReSTOR SN60D3
Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.
Active Comparator: SN60AT
AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT
Device: Acrysof Natural Monofocal SN60AT
Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.


Outcome Measures

Primary Outcome Measures :
  1. Near Best Corrected Visual Acuity (BCVA) - Binocular [ Time Frame: 6 months after second eye implantation ]
    Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

  2. Near Uncorrected Visual Acuity (UCVA) Binocular [ Time Frame: 6 months after second eye implantation ]
    Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

  3. Near Best Corrected Visual Acuity Left Eye (BCVA LE) [ Time Frame: 6 months after second eye implantation ]
    Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

  4. Near Uncorrected Visual Acuity Left Eye (UCVA LE) [ Time Frame: 6 months after second eye implantation ]
    Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

  5. Near Best Corrected Visual Acuity Right Eye (BCVA RE) [ Time Frame: 6 months after second eye implantation ]
    Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

  6. Near Uncorrected Visual Acuity Right Eye (UCVA RE) [ Time Frame: 6 months after second eye implantation ]
    Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which 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:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Written informed consent
  • Age: ≥ 50 years ≤ 75 years
  • Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
  • Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
  • Potential post operative Visual Acuity (VA) ≥ 20/40
  • Second eye surgery to take place no longer than 45 days after the first implant

Exclusion:

  • Irregular optical aberrations;
  • Pupil diameter in scotopic conditions more than 6 mm
  • Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
  • Other exclusions as from ReSTOR Directions for Use (DFU)
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): NCT00759668


Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information

Responsible Party: Marcello Fornoni, Alcon
ClinicalTrials.gov Identifier: NCT00759668     History of Changes
Other Study ID Numbers: IT 06 01
First Posted: September 25, 2008    Key Record Dates
Results First Posted: January 26, 2011
Last Update Posted: January 26, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases