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Clinical Investigation of the Next-Generation Intraocular Lenses

NCT03372434 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2025-06-24

Study results available
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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

  • Cataract

Interventions

DEVICE

Investigational Intraocular Lens Device #1: Model ZFR00

IOL replaces the natural lens removed during cataract surgery.

DEVICE

Investigational Intraocular Lens Device #1: Model ZYR00

IOL replaces the natural lens removed during cataract surgery.

DEVICE

TECNIS Multifocal Intraocular Lens: Model ZLB00

IOL replaces the natural lens removed during cataract surgery.

Sponsors & Collaborators

  • Abbott Medical Optics

    lead INDUSTRY

Principal Investigators

  • Abbott Medical Optics Clinical Trials · Abbott Medical Optics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2018-07-11
Completion
2018-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03372434 on ClinicalTrials.gov