MedTrace Logo

PROOF-OF-CONCEPT STUDY FOR NEW INTRAOCULAR LENS, MODEL C0002

NCT05531292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-07-20

No results posted yet for this study

Summary

Prospective, two-arm, randomized, bilateral, subject/evaluator-masked clinical study to evaluate the distance visual acuity, peripheral refractive error and functional vision of the EPV IOL compared to a standard monofocal control IOL.

Conditions

  • Cataracts

Interventions

DEVICE

Model C0002

Eligible subjects will be randomized in a 1:1 ratio to the investigational IOL Model C0002 in both eyes for the duration of the study.

DEVICE

Model ZCB00/DCB00

Eligible subjects will be randomized in a 1:1 ratio to the control IOL Model ZCB00 in both eyes for the duration of the study.

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Surgical Vision, Inc. Clinical Trial · Johnson & Johnson Surgical Vision, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2025-05-20
Completion
2025-05-20

Countries

  • France

Study Locations

More Related Trials

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 NCT05531292 on ClinicalTrials.gov