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Clinical Investigation of the Next Generation Intraocular Lens

NCT03500198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2020-06-25

Study results available
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Summary

An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.

Conditions

  • Cataract

Interventions

DEVICE

Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL

Intraocular lens replaces the natural lens removed during cataract surgery.

DEVICE

Control Monofocal Intraocular Lens: TECNIS Monofocal IOL

Intraocular lens replaces the natural lens removed during cataract surgery.

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • Devi Priya Janakiraman, OD, FAAO · Johnson & Johnson Surgical Vision, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2019-06-05
Completion
2019-06-05
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 NCT03500198 on ClinicalTrials.gov