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

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759668
• Other study ID #: IT 06 01
• Status: Completed
• Phase: N/A
• First received: September 24, 2008
• Last updated: January 5, 2011
• Start date: May 2007
• Est. completion date: September 2009

Study information

• Verified date: January 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Acrysof Natural ReSTOR SN60D3
Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.
• Acrysof Natural Monofocal SN60AT
Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No