Post-market Evaluation of Clinical Outcomes in China for the TECNIS Model ZMT
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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. [1 day postoperative]
The axis change is calculated as the absolute difference between intended IOL axis and the axis measured at follow-up visit(s).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female at least 22 years of age
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Have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation
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Regular corneal astigmatism that is planned for correction with an intraocular lens in the study eye(s)
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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
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Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.
Exclusion Criteria:
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Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
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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.
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Planned monovision correction (one eye designated for near correction)
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Severe or unstable systemic disease that may affect the heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, or psychoneurological dysfunction
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Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiangya Hospital of Central South University | Kaifu | Changsha | China | 410008 |
| 2 | Daqing Oil Field Central South University | Daqing | Heilongjiang | China | 163000 |
| 3 | Tianjin Medical University Eye Hospital | Tianjin | Nankai | China | 300384 |
| 4 | Shanxi Eye Hospital | Taiyuan | Shanxi | China | 030072 |
| 5 | Eye Hospital, Wenzhou Medical University | Wenzhou | Zhejiang | China | 325027 |
Sponsors and Collaborators
- Johnson & Johnson Surgical Vision, Inc.
Investigators
- Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DIOL-301-CZMT