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

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT04954898
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-08
• Study Start: 2021-08-11
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. Male or female at least 22 years of age
2. Have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation
3. Regular corneal astigmatism that is planned for correction with an intraocular lens in the study eye(s)
4. 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
5. Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.

Exclusion Criteria

1. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit

2. 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.

3. Planned monovision correction (one eye designated for near correction)

4. Severe or unstable systemic disease that may affect the heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, or psychoneurological dysfunction

5. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (7)

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

Shanghai Aier Eye Hospital; 🇨🇳 Xuhui, Shanghai, China

Shanxi Eye Hospital; 🇨🇳 Taiyuan, Shanxi, China

Eye Hospital, Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China