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

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: +1 904 9553543; Email: AANDERS1@its.jnj.com

Study Locations

• China
  • Changsha
    • Kaifu, Changsha, China, 410008
      • Xiangya Hospital of Central South University
  • Guangdong
    • Guangzhou, Guangdong, China, 510010
      • Guangzhou Aier Eye Hospital
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163000
      • Daqing Oil Field Central South University
  • Nankai
    • Tianjin, Nankai, China, 300384
      • Tianjin Medical University Eye Hospital
  • Shanghai
    • Xuhui, Shanghai, China, 200336
      • Shanghai Aier Eye Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030072
      • Shanxi Eye Hospital
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Eye Hospital, Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: DIOL-301-CZMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No