To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Cataract extraction and implantation of a posterior chamber IOL
Cataract extraction and implantation of a posterior chamber IOL
Distance-corrected intermediate ETDRS LogMar visual acuity
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm
Time frame: 12 Months
Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group
Time frame: 12 Months
Defocus curve testing with ETDRS chart
Monocular diopters of depth of focus (DOF)
Time frame: 12 Months
Best corrected distance ETDRS LogMar visual acuity vs control
Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group
Time frame: 12 Months
Best corrected distance ETDRS LogMar visual acuity
Monocular photopic best corrected distance visual acuity (BCDVA)
Time frame: 12 Months
Distance-corrected near ETDRS LogMar visual acuity
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm
Time frame: 12 Months
Distance-corrected near ETDRS LogMar visual acuity vs control
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group
Time frame: 12 Months
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