This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.
This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
UV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan.
Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
Photopic monocular CDVA, 400 cm
Time frame: 6 Months post second eye implantation
Photopic monocular CIVA, 60 cm
Time frame: 6 Months post second eye implantation
Photopic monocular CNVA, 40 cm
Time frame: 6 Months post second eye implantation
Rates of adverse events vs. ISO 11979-7:2018 SPE rate
Time frame: 6 Months post second eye implantation
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