Clinical trial NCT04954898: Post-market Evaluation of Clinical Outcomes in China for the TECNIS Model ZMT
Official title: Post-market Evaluation of Clinical Outcomes in China for the TECNIS® Multifocal Toric 1-Piece Intraocular Lens Model Series ZMT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-08
Enrollment: 102
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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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Primary outcomes:
measure: 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.
timeFrame: 1 day postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Kaifu
country: China
facility: Xiangya Hospital of Central South University
state: Changsha
city: Guangzhou
country: China
facility: Guangzhou Aier Eye Hospital
state: Guangdong
city: Daqing
country: China
facility: Daqing Oil Field Central South University
state: Heilongjiang
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Nankai
city: Xuhui
country: China
facility: Shanghai Aier Eye Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Eye Hospital
state: Shanxi
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References: