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Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens

NCT03949335 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2021-08-27

Study results available
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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

  • Cataract
  • Corneal Astigmatism

Interventions

DEVICE

IOL Model ZFR00V

Bilateral implantation with Investigational IOL Model ZFR00V

DEVICE

IOL Model ZCB00

Bilateral Implantation with control IOL Model ZCB00

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Surgical Vision Clinical Trials · Johnson & Johnson Surgical Vision

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-06-18
Completion
2020-06-18
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 NCT03949335 on ClinicalTrials.gov