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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Cataract

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04954898

DIOL-301-CZMT

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Study Lens

Experimental group

Description:

TECNIS Multifocal Toric 1-piece lens, Model ZMT

Treatment:

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