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COMPLETED NA

Clinical Investigation of the Next-Generation Intraocular Lenses

NCT03372434 · View on ClinicalTrials.gov ↗

Study Summary

This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL. The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.

Conditions Studied

Interventions

  • DEVICE Investigational Intraocular Lens Device #1: Model ZFR00
  • DEVICE Investigational Intraocular Lens Device #1: Model ZYR00
  • DEVICE TECNIS Multifocal Intraocular Lens: Model ZLB00

Study Locations (12)

Texas

  • Texas Eye and Laser Center — Hurst
  • Lehmann Eye Center — Nacogdoches
  • Focal Point Vision — San Antonio

Maryland

  • Chesapeake Eye Care & Laser Center — Annapolis
  • Eye Doctors of Washington — Chevy Chase

Tennessee

  • Loden Vision Centers — Goodlettsville
  • Eye Specialty Group — Memphis

California

  • Empire Eye & Laser Center — Bakersfield

Florida

  • Katzen Eye Care and Laser Center — Boynton Beach

Pennsylvania

  • Scott & Christie and Associates, PC — Cranberry Township

South Carolina

  • Carolina EyeCare Physicians, LLC — Mt. Pleasant

Washington

  • Clarus Eye Centre — Lacey

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2018-01-16
Est. Completion 2018-10-30
Phase NA

Sponsor

Abbott Medical Optics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03372434

The ClinicalTrials.gov registry entry for NCT03372434 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 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Optics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 3 interventions — of which Investigational Intraocular Lens Device #1: Model ZFR00 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: NCT03372434 reports 12 study locations spanning 8 distinct geographic areas — top geographies include Texas, Maryland, Tennessee. 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 NCT03372434 about?

NCT03372434 is a clinical study titled "Clinical Investigation of the Next-Generation Intraocular Lenses". This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL. The study will be conducted at up to 14 sites in the U.S.A a...

What is the current status of trial NCT03372434?

This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2018-01-16. Estimated completion is 2018-10-30.

What conditions does trial NCT03372434 study?

This clinical trial studies the following conditions: Cataract. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03372434?

The interventions under investigation include: Investigational Intraocular Lens Device #1: Model ZFR00 (DEVICE), Investigational Intraocular Lens Device #1: Model ZYR00 (DEVICE), TECNIS Multifocal Intraocular Lens: Model ZLB00 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03372434?

This trial is sponsored by Abbott Medical Optics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03372434 being conducted?

This trial has 12 study locations across California, Florida, Maryland, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial