Post-market Evaluation of Clinical Outcomes in China for the TECNIS Model ZMT
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.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: Study Lens|
TECNIS Multifocal Toric 1-piece lens, Model ZMT
Device: Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT
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.
Primary Outcome Measures
- 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. [1 day postoperative]
The axis change is calculated as the absolute difference between intended IOL axis and the axis measured at follow-up visit(s).
Male or female at least 22 years of age
Have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation
Regular corneal astigmatism that is planned for correction with an intraocular lens in the study eye(s)
Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative visits that are required by the study protocol
Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.
Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
Ocular disease (other than cataract) that may significantly affect postoperative vision, such as visually significant keratopathy, macular lesions, diabetic retinopathy, chronic or severe uveitis, etc.
Planned monovision correction (one eye designated for near correction)
Severe or unstable systemic disease that may affect the heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, or psychoneurological dysfunction
Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study.
Contacts and Locations
|1||Shanxi Eye Hospital||Taiyuan||Shanxi||China||030072|
|2||Eye Hospital, Wenzhou Medical University||Wenzhou||Zhejiang||China||325027|
Sponsors and Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision
Study Documents (Full-Text)None provided.