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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00759668
First received: September 24, 2008
Last updated: January 5, 2011
Last verified: January 2011

September 24, 2008
January 5, 2011
May 2007
September 2009   (final data collection date for primary outcome measure)
  • Near Best Corrected Visual Acuity (BCVA) - Binocular [ Time Frame: 6 months after second eye implantation ] [ Designated as safety issue: No ]
    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.
  • Near Uncorrected Visual Acuity (UCVA) Binocular [ Time Frame: 6 months after second eye implantation ] [ Designated as safety issue: No ]
    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.
  • Near Best Corrected Visual Acuity Left Eye (BCVA LE) [ Time Frame: 6 months after second eye implantation ] [ Designated as safety issue: No ]
    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.
  • Near Uncorrected Visual Acuity Left Eye (UCVA LE) [ Time Frame: 6 months after second eye implantation ] [ Designated as safety issue: No ]
    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.
  • Near Best Corrected Visual Acuity Right Eye (BCVA RE) [ Time Frame: 6 months after second eye implantation ] [ Designated as safety issue: No ]
    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.
  • Near Uncorrected Visual Acuity Right Eye (UCVA RE) [ Time Frame: 6 months after second eye implantation ] [ Designated as safety issue: No ]
    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.
Changes in visual acuity [ Time Frame: Baseline, 1,3 and 6 months after second implantation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00759668 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
Not Provided

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cataract
  • Device: Acrysof Natural ReSTOR SN60D3
    Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.
  • Device: Acrysof Natural Monofocal SN60AT
    Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.
  • Experimental: SN60D3
    AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3
    Intervention: Device: Acrysof Natural ReSTOR SN60D3
  • Active Comparator: SN60AT
    AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT
    Intervention: Device: Acrysof Natural Monofocal SN60AT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
September 2009
September 2009   (final data collection date for primary outcome measure)

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)
Both
50 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00759668
IT 06 01
No
Marcello Fornoni, Alcon
Alcon Research
Not Provided
Not Provided
Alcon Research
January 2011

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