The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.
Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
Alcon Investigative Site
Fukuoka, Japan
Alcon Investigative Site
Tokyo, Japan
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
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