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Clinical Investigation of Two Tecnis Investigational Lenses

NCT04890249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2025-05-23

No results posted yet for this study

Summary

This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL.

The study will be conducted at up to 15 sites in EU, AU, NZ and/or AP and will enroll up to 225 subjects to achieve approximately 67 bilaterally implanted subjects in each lens group. Allowing for 10% lost-to-follow-up, this will achieve approximately 60 evaluable subjects in each lens group at 1, 3, and 6 months. The eye implanted first will be considered the primary (monocular) study eye.

Conditions

  • Cataract
  • Corneal Astigmatism

Interventions

DEVICE

Investigational IOL Model C1V000

IOL replaces the natural lens removed during cataract surgery.

DEVICE

Investigational IOL Model C2V000

IOL replaces the natural lens removed during cataract surgery.

DEVICE

Control IOL Model ICB00

IOL replaces the natural lens removed during cataract surgery.

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
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • Australia
  • New Zealand

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 NCT04890249 on ClinicalTrials.gov