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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04954898
• Other study ID #: DIOL-301-CZMT
• Status: Completed
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: January 10, 2024

Study information

• Verified date: February 2024
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

-

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
China	Daqing Oil Field Central South University	Daqing	Heilongjiang
China	Guangzhou Aier Eye Hospital	Guangzhou	Guangdong
China	Xiangya Hospital of Central South University	Kaifu	Changsha
China	Shanxi Eye Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Eye Hospital	Tianjin	Nankai
China	Eye Hospital, Wenzhou Medical University	Wenzhou	Zhejiang
China	Shanghai Aier Eye Hospital	Xuhui	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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