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Clinical Investigation of the TECNIS 1-Piece Intraocular Lens

NCT05090787 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-02-06

No results posted yet for this study

Summary

This study is a 6-month, prospective, comparative, multicenter, bilateral, parallel group, randomized (2:1), subject/evaluator masked clinical investigation of the investigational mDCB00 IOL as compared to the DCB00 IOL.

The study will be conducted at up to 8 sites in countries where both the investigational and control lenses are approved for market and/or for evaluation in a clinical study and will include a total of up to 200 subjects. Subjects will be randomly assigned to receive either the test lens or the control lens in both eyes.

Conditions

  • Cataract

Interventions

DEVICE

Investigational mDCB00

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

DEVICE

Control DCB00

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
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-07-01
Completion
2025-07-01
FDA Device
Yes

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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 NCT05090787 on ClinicalTrials.gov