The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.
This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.
Newsom Eye and Laser Center
Sebring, Florida, United States
Binocular Near Visual Acuity
binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.
Time frame: 3 months postop
Prediction Accuracy
Percentage of eyes with postoperative refractive accuracy within 0.5D of target
Time frame: 3 months postop
Spectacle Independence
Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time")
Time frame: 3 months postop
Patient Spectacle Independence
Patients reporting rarely or never needing glasses overall
Time frame: 3 months postop
Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"
This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.
Time frame: 3 months postop
Manifest Refraction
Manifest refraction (residual spherical equivalent refraction)
Time frame: 3 months postop
Residual Cylinder
Residual refractive cylinder after surgery
Time frame: 3 months
Uncorrected Distance Visual Acuity
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Bilateral uncorrected distance visual acuity
Time frame: 3 months postop
Uncorrected Intermediate Visual Acuity
Bilateral uncorrected visual acuity at 66 cm
Time frame: 3 months postop
Uncorrected Near Visual Acuity
Bilateral uncorrected near visual acuity at 40 cm
Time frame: 3 months postop
Corrected Distance Visual Acuity
Bliateral corrected distance visual acuity
Time frame: 3 months postop
Distance Corrected Intermediate Visual Acuity
Bliateral distance corrected visual acuity at 66 cm
Time frame: 3 months postop