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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xiangya Hospital of Central South University, Kaifu, Changsha, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT

Device

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 outcomes

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.

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Jul 8, 2021
Registry last updated: May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed