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Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

NCT05025345 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2023-08-28

Study results available
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Summary

This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL.

The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.

Conditions

  • Cataract

Interventions

DEVICE

Tecnis Eyhance

Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

DEVICE

Tecnis 1 piece IOL

Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-02
Primary Completion
2022-06-17
Completion
2022-06-17
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 NCT05025345 on ClinicalTrials.gov