NCT05364983

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started May 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
May 2023Nov 2026

First Submitted

Initial submission to the registry

May 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

March 9, 2023

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

May 4, 2022

Last Update Submit

March 7, 2023

Conditions

CataractPresbyopia

Outcome Measures

Primary Outcomes (5)

  • Distance-corrected intermediate ETDRS LogMar visual acuity

    Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm

    12 Months

  • Distance-corrected intermediate ETDRS LogMar visual acuity vs Control

    Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group

    12 Months

  • Defocus curve testing with ETDRS chart

    Monocular diopters of depth of focus (DOF)

    12 Months

  • Best corrected distance ETDRS LogMar visual acuity vs control

    Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group

    12 Months

  • Best corrected distance ETDRS LogMar visual acuity

    Monocular photopic best corrected distance visual acuity (BCDVA)

    12 Months

Secondary Outcomes (2)

  • Distance-corrected near ETDRS LogMar visual acuity

    12 Months

  • Distance-corrected near ETDRS LogMar visual acuity vs control

    12 Months

Study Arms (2)

Investigational IOL

EXPERIMENTAL

Juvene® IOL

Device: Juvene IOL

Control IOL

ACTIVE COMPARATOR

Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

Interventions

Juvene IOLDEVICE

Cataract extraction and implantation of a posterior chamber IOL

Investigational IOL
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)DEVICE

Cataract extraction and implantation of a posterior chamber IOL

Control IOL

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be 22 years of age or older
  • Able to comprehend and provide written informed consent
  • Willing and able to comply with schedule for follow-up visits
  • Demonstrate sufficient cognitive awareness to comply with examination procedures

You may not qualify if:

  • Subjects with clinically significant dry eye syndrome (DES) expected to impact postoperative visual acuity
  • Subjects taking medications that may affect ocular function (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents)
  • Prior intraocular or corneal surgery (including corneal refractive correction i.e., LASIK, PRK, etc.)
  • Any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Garg S, De Jesus MT, Fletcher LM, Chayet A, Barragan E, Casey P. Twelve-month clinical outcomes after implantation of a new, modular, anterior shape-changing fluid optic intraocular lens. J Cataract Refract Surg. 2022 Oct 1;48(10):1134-1140. doi: 10.1097/j.jcrs.0000000000000935.

    PMID: 35297798BACKGROUND

Related Links

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Patrick R Casey, O.D.

    LensGen, Inc.

    STUDY DIRECTOR

Central Study Contacts

Patrick R Casey, O.D.

CONTACT

(949) 472-5112info@lensgen.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The subject will be masked to randomization assignment and will be unmasked at the completion of the study. Scheduled masked postoperative assessments will be performed by a masked examiner
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A prospective, randomized, controlled, double-masked, phased, multicenter clinical study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 6, 2022

Study Start

May 1, 2023

Primary Completion

November 1, 2024

Study Completion (Estimated)

November 1, 2026

Last Updated

March 9, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share