Assess the visual, refractive, and patient-reported outcomes - including spectacle independence - of bilateral cataract surgery with implantation of the TECNIS PureSee extended depth of focus (EDOF) IOL in subjects with visually significant cataract in a real-world setting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Bilateral implantation of the TECNIS PureSee extended depth of focus IOL
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Monocular and binocular uncorrected distance visual acuity (UCDVA) at 1-3 months postoperatively
Time frame: 1 month and 3 months post cataract surgery
Monocular and binocular uncorrected intermediate visual acuity (UCIVA) at 66 cm
Time frame: 3 months post cataract surgery
Patient-reported spectacle independence for distance, intermediate, and near tasks assessed via validated questionnaire (AIOLIS questionnaire)
Time frame: 3 months post cataract surgery
Monocular and binocular uncorrected near visual acuity (UCNVA) at 40 cm at 3 months postoperatively
Time frame: 3 months post cataract surgery
Manifest refraction spherical equivalent (MRSE) and percentage of eyes within ±0.50 D and ±1.00 D of the refractive target
Time frame: 3 months post cataract surgery
Rate (%) of visual disturbances using the AIOLIS validated questionnaire
Time frame: 3 months post cataract surgery
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