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

NCT ID: NCT04954898

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2024-01-10

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Lens

TECNIS Multifocal Toric 1-piece lens, Model ZMT

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Surgical Vision Clinical Trials

Role: STUDY_DIRECTOR

Johnson & Johnson Surgical Vision

Locations

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 Municipality, China

Shanxi Eye Hospital

Taiyuan, Shanxi, China

Eye Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

DIOL-301-CZMT

Identifier Type: -

Identifier Source: org_study_id