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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acrysof Natural ReSTOR SN60D3

Acrysof Natural Monofocal SN60AT

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SN60D3

SN60AT

Arm Description

AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3

AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00759668

First Posted

September 24, 2008

Last Updated

January 5, 2011

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00759668

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SN60D3

Arm Type

Experimental

Arm Description

AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3

Arm Title

SN60AT

Arm Type

Active Comparator

Arm Description

AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT

Intervention Type

Device

Intervention Name(s)

Acrysof Natural ReSTOR SN60D3

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Acrysof Natural Monofocal SN60AT

Intervention Description

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

Primary Outcome Measure Information:

Title

Near Best Corrected Visual Acuity (BCVA) - Binocular

Description

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.

Time Frame