The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.
This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.
Study Type
OBSERVATIONAL
Enrollment
20
Vivity intraocular lens (IOL)
Image Plus Laser Eye Centre
Winnipeg, Manitoba, Canada
Binocular Uncorrected Distance Visual Acuity (logMAR)
Binocular uncorrected distance visual acuity (logMAR)
Time frame: 3 months postoperatively
Binocular Uncorrected Intermediate Visual Acuity (logMAR)
Binocular uncorrected intermediate visual acuity (logMAR)
Time frame: 3 months postoperatively
Binocular Uncorrected Near Visual Acuity (logMAR)
Binocular uncorrected near visual acuity (logMAR)
Time frame: 3 months postoperatively
Prediction Error
Percentage of eyes with absolute prediction error of 0.5D or less
Time frame: 3 months postoperatively
Binocular Corrected Distance Visual Acuity (logMAR)
Binocular corrected distance visual acuity (logMAR)
Time frame: 3 months postoperatively
Binocular Distance Corrected Intermediate Visual Acuity (logMAR)
Binocular distance corrected intermediate visual acuity (logMAR)
Time frame: 3 months postoperatively
Binocular Distance Corrected Near Visual Acuity (logMAR)
Binocular distance corrected near visual acuity (logMAR)
Time frame: 3 months postoperatively
Monocular Corrected Distance Visual Acuity (logMAR)
Monocular corrected distance visual acuity (logMAR)
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Time frame: 3 months postoperatively
Monocular Distance Corrected Intermediate Visual Acuity (logMAR)
Monocular distance corrected intermediate visual acuity (logMAR)
Time frame: 3 months postoperatively
Monocular Distance Corrected Near Visual Acuity (logMAR)
Monocular distance corrected near visual acuity (logMAR)
Time frame: 3 months postoperatively
Manifest Refraction Spherical Equivalent
Manifest refraction spherical equivalent
Time frame: 3 months postoperatively
Questionnaire
Questionnaire for visual disturbance scores (QUVID)
Time frame: 3 months postoperatively
Percentage of Participants With Spectacle Independence
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.
Time frame: 3 months
Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)
Binocular distance-corrected low contrast distance visual acuity (logMAR)
Time frame: 3 months postoperatively