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Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

NCT05364983 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-03-09

No results posted yet for this study

Summary

To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.

Conditions

Interventions

DEVICE

Juvene IOL

Cataract extraction and implantation of a posterior chamber IOL

DEVICE

Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

Cataract extraction and implantation of a posterior chamber IOL

Sponsors & Collaborators

  • LensGen, Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick R Casey, O.D. · LensGen, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-11-30
Completion
2026-11-30
FDA Device
Yes

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Entities

Diseases

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 NCT05364983 on ClinicalTrials.gov