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

NCT00759668 | Completed Results

• 1 other identifier: IT 06 01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (6)

• Near Best Corrected Visual Acuity (BCVA) - Binocular

  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.

  6 months after second eye implantation

• Near Uncorrected Visual Acuity (UCVA) Binocular

  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.

  6 months after second eye implantation

• Near Best Corrected Visual Acuity Left Eye (BCVA LE)

  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.

  6 months after second eye implantation

• Near Uncorrected Visual Acuity Left Eye (UCVA LE)

  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.

  6 months after second eye implantation

• Near Best Corrected Visual Acuity Right Eye (BCVA RE)

  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 months after second eye implantation

• Near Uncorrected Visual Acuity Right Eye (UCVA RE)

  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.

  6 months after second eye implantation

Study Arms (2)

SN60D3

EXPERIMENTAL

AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3

Device: Acrysof Natural ReSTOR SN60D3

SN60AT

ACTIVE COMPARATOR

AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT

Device: Acrysof Natural Monofocal SN60AT

Interventions

Acrysof Natural ReSTOR SN60D3 DEVICE

Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.

SN60D3

Acrysof Natural Monofocal SN60AT DEVICE

Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.

SN60AT

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Irregular optical aberrations;
• Pupil diameter in scotopic conditions more than 6 mm
• Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Limitations and Caveats

Visual acuity data were collected in different units (i.e. c, twentieth, decimal, Jaeger) and were converted to LogMAR after inclusion in the database. This led to inevitable approximations of the data.

Results Point of Contact

• Title: Marcello Fornoni
• Organization: Alcon Italia SpA

marcello.fornoni@alconlabs.com

39.02.81.303.226

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: May 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 26, 2011
• Results First Posted: January 26, 2011

Record last verified: 2011-01

Locations

US (1)