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Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
NCT04210232 · View on ClinicalTrials.gov ↗
Study Summary
This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.
Conditions Studied
Interventions
- DEVICE TECNIS® TORIC II Intraocular Lens (IOL)
Study Locations (12)
Texas
- Key & Whitman Eye Center — Dallas
- Texas Eye and Laser Center — Hurst
- Parkhurst NuVision — San Antonio
Maryland
- Chesapeake Eye Care and Laser Center — Annapolis
- Eye Doctors of Washington — Chevy Chase
California
- Empire Eye & Laser Center — Bakersfield
Iowa
- Jones Eye Clinic — Sioux City
Michigan
- Oakland Ophthalmic Surgery, P.C. — Birmingham
Missouri
- Tekwani Vision Center — St Louis
Ohio
- Cincinnati Eye Institute — Cincinnati
South Carolina
- Carolina Cataract & Laser Center — Ladson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2020-09-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04210232
The ClinicalTrials.gov registry entry for NCT04210232 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Surgical Vision, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Cataract appearing as the primary indexed condition, and to 1 intervention — of which TECNIS® TORIC II Intraocular Lens (IOL) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04210232 reports 12 study locations spanning 9 distinct geographic areas — top geographies include Texas, Maryland, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04210232 about?
NCT04210232 is a clinical study titled "Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL". This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.
What is the current status of trial NCT04210232?
This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2020-01-14. Estimated completion is 2020-09-11.
What conditions does trial NCT04210232 study?
This clinical trial studies the following conditions: Cataract, Corneal Astigmatism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04210232?
The interventions under investigation include: TECNIS® TORIC II Intraocular Lens (IOL) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04210232?
This trial is sponsored by Johnson & Johnson Surgical Vision, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04210232 being conducted?
This trial has 12 study locations across California, Iowa, Maryland, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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