This is a single-masked, randomized, cross-over, dispensing, 6- visit pilot study. The purpose of this clinical study is to evaluate the performance of two marketed multifocal lenses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
Dailies Total 1 Multifocal Contact Lens
Biotrue ONEday for Presbyopia Contact Lenses
BioTrue ONEDay Spherical
Golden Vision
Sarasota, Florida, United States
ABQ Eye Care
Albuquerque, New Mexico, United States
Sacco Eye Group
Vestal, New York, United States
West Bay Eye Associates
Warwick, Rhode Island, United States
Distance Binocular Visual Acuity
Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.
Time frame: 1-Week Follow-up
Near Binocular Visual Acuity
Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.
Time frame: 1-Week Follow-up
Overall Quality of Vision
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 1-Week Follow-up
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Botetourt Eyecare, LLC
Salem, Virginia, United States