Post-market Evaluation of Clinical Outcomes in China for the TECNIS Model ZMT

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Post-market Evaluation of Clinical Outcomes in China for the TECNIS® Multifocal Toric 1-Piece Intraocular Lens Model Series ZMT

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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. -

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Lens<br>TECNIS Multifocal Toric 1-piece lens, Model ZMT | Device: Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 day postoperative |