This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Multifocal Toric 1-Piece IOL. The study will enroll up to 120 subjects from up to 8 sites in China. The subjects will be followed for 12-months postoperatively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with TECNIS Multifocal Toric 1-Piece IOL.
Xiangya Hospital of Central South University
Kaifu, Changsha, China
Guangzhou Aier Eye Hospital
Guangzhou, Guangdong, China
Daqing Oil Field Central South University
Daqing, Heilongjiang, China
Tianjin Medical University Eye Hospital
Tianjin, Nankai, China
The percentage of eyes that are measured at the 1-day postoperative visit to demonstrate ≤10º change from The intended IOL axis at the end of surgery.
The axis change is calculated as the absolute difference between intended IOL axis and the axis measured at follow-up visit(s).
Time frame: 1 day postoperative
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Shanghai Aier Eye Hospital
Xuhui, Shanghai Municipality, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China