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Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
NCT03949335 · View on ClinicalTrials.gov ↗
Study Summary
This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization. After signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule
Conditions Studied
Interventions
- DEVICE IOL Model ZFR00V
- DEVICE IOL Model ZCB00
Study Locations (15)
Texas
- Key-Whitman Eye Center — Dallas
- Berkeley Eye Institute — Houston
- Texas Eye and Laser Center — Hurst
- Lehmann Eye Center — Nacogdoches
- Focal Point Vision — San Antonio
California
- Empire Eye & Laser Center — Bakersfield
- Wolstan & Goldberg Eye Associates — Torrance
Florida
- Katzen Eye Care & Laser Center — West Palm Beach
Iowa
- Jones Eye Clinic — Sioux City
Maryland
- Chesapeake Eye Care & Laser Center — Annapolis
Ohio
- Cincinnati Eye Institute — Blue Ash
Pennsylvania
- Scott & Christie and Associates, PC — Cranberry Township
South Carolina
- Carolina EyeCare Physicians — Mt. Pleasant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2020-06-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03949335
The ClinicalTrials.gov registry entry for NCT03949335 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 272 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 2 interventions — of which IOL Model ZFR00V 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: NCT03949335 reports 15 study locations spanning 10 distinct geographic areas — top geographies include Texas, California, Florida. 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 NCT03949335 about?
NCT03949335 is a clinical study titled "Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens". This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in appro...
What is the current status of trial NCT03949335?
This trial is currently completed. It is a NA study. The enrollment target is 272 participants. The study started on 2019-07-31. Estimated completion is 2020-06-18.
What conditions does trial NCT03949335 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 NCT03949335?
The interventions under investigation include: IOL Model ZFR00V (DEVICE), IOL Model ZCB00 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03949335?
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 NCT03949335 being conducted?
This trial has 15 study locations across California, Florida, Iowa, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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