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
  Purpose

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 Intervention
Cataract
Device: Acrysof Natural ReSTOR SN60D3
Device: Acrysof Natural Monofocal SN60AT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Enrollment: 35
Study Start Date: May 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Marcello Fornoni, Alcon
ClinicalTrials.gov Identifier: NCT00759668     History of Changes
Other Study ID Numbers: IT 06 01
Study First Received: September 24, 2008
Results First Received: October 12, 2010
Last Updated: January 5, 2011
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 11, 2014