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

NCT04954898 | Completed

• 1 other identifier: DIOL-301-CZMT
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study Lens

EXPERIMENTAL

TECNIS Multifocal Toric 1-piece lens, Model ZMT

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

Interventions

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.

Study Lens

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (7)

Xiangya Hospital of Central South University

Kaifu, Changsha, 410008, China

Location

Guangzhou Aier Eye Hospital

Guangzhou, Guangdong, 510010, China

Location

Daqing Oil Field Central South University

Daqing, Heilongjiang, 163000, China

Location

Tianjin Medical University Eye Hospital

Tianjin, Nankai, 300384, China

Location

Shanghai Aier Eye Hospital

Xuhui, Shanghai Municipality, 200336, China

Location

Shanxi Eye Hospital

Taiyuan, Shanxi, 030072, China

Location

Eye Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: August 11, 2021
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (7)