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

Conditions

Cataract

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

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Interventions

DEVICEAcrysof Natural ReSTOR SN60D3

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

DEVICEAcrysof Natural Monofocal SN60AT

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

No

Inclusion 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)

Design outcomes

Primary

Measure	Time frame	Description
Near Best Corrected Visual Acuity (BCVA) - Binocular	6 months after second eye implantation	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	6 months after second eye implantation	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)	6 months after second eye implantation	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)	6 months after second eye implantation	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)	6 months after second eye implantation	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)	6 months after second eye implantation	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.

Countries

United States

Participant flow

Recruitment details

35 patients, diagnosed with bilateral cataracts age related, requiring extraction of cataracts in both eyes followed by implantation of a posterior chamber intraocular lens, were recruited.

Pre-assignment details

Patients meeting the inclusion/exclusion criteria were enrolled.

Participants by arm

Arm	Count
SN60D3 Intraocular Lens Acrysof Natural Restor SN60D3	17
SN60AT Intraocular Lens Acrysof Natural Monofocal SN60AT	18
Total	35

Baseline characteristics

Characteristic	Total	SN60D3	SN60AT
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	26 Participants	14 Participants	12 Participants
Age, Categorical Between 18 and 65 years	9 Participants	3 Participants	6 Participants
Sex: Female, Male Female	21 Participants	10 Participants	11 Participants
Sex: Female, Male Male	14 Participants	7 Participants	7 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	2 / 17	3 / 18
serious Total, serious adverse events	1 / 17	1 / 118

Outcome results

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.