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Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens (Nirvana)

Primary Purpose

Cataract, Presbyopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Juvene IOL
Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Sponsored by
LensGen, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

  • 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
  • Other inclusion criteria specified in the protocol may apply.

Key Exclusion Criteria:

  • 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.)
  • Other exclusion criteria specified in the protocol may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Investigational IOL

    Control IOL

    Arm Description

    Juvene® IOL

    Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

    Outcomes

    Primary Outcome Measures

    Distance-corrected intermediate ETDRS LogMar visual acuity
    Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm
    Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
    Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group
    Defocus curve testing with ETDRS chart
    Monocular diopters of depth of focus (DOF)
    Best corrected distance ETDRS LogMar visual acuity vs control
    Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group
    Best corrected distance ETDRS LogMar visual acuity
    Monocular photopic best corrected distance visual acuity (BCDVA)

    Secondary Outcome Measures

    Distance-corrected near ETDRS LogMar visual acuity
    Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm
    Distance-corrected near ETDRS LogMar visual acuity vs control
    Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group

    Full Information

    First Posted
    May 4, 2022
    Last Updated
    March 7, 2023
    Sponsor
    LensGen, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05364983
    Brief Title
    Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens
    Acronym
    Nirvana
    Official Title
    A Prospective, Randomized, Controlled, Double-Masked, Phased, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of the LensGen® Juvene® Intraocular Lens
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    November 2024 (Anticipated)
    Study Completion Date
    November 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    LensGen, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Presbyopia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A prospective, randomized, controlled, double-masked, phased, multicenter clinical study
    Masking
    ParticipantCare Provider
    Masking Description
    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
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Investigational IOL
    Arm Type
    Experimental
    Arm Description
    Juvene® IOL
    Arm Title
    Control IOL
    Arm Type
    Active Comparator
    Arm Description
    Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
    Intervention Type
    Device
    Intervention Name(s)
    Juvene IOL
    Intervention Description
    Cataract extraction and implantation of a posterior chamber IOL
    Intervention Type
    Device
    Intervention Name(s)
    Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
    Intervention Description
    Cataract extraction and implantation of a posterior chamber IOL
    Primary Outcome Measure Information:
    Title
    Distance-corrected intermediate ETDRS LogMar visual acuity
    Description
    Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm
    Time Frame
    12 Months
    Title
    Distance-corrected intermediate ETDRS LogMar visual acuity vs Control
    Description
    Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group
    Time Frame
    12 Months
    Title
    Defocus curve testing with ETDRS chart
    Description
    Monocular diopters of depth of focus (DOF)
    Time Frame
    12 Months
    Title
    Best corrected distance ETDRS LogMar visual acuity vs control
    Description
    Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group
    Time Frame
    12 Months
    Title
    Best corrected distance ETDRS LogMar visual acuity
    Description
    Monocular photopic best corrected distance visual acuity (BCDVA)
    Time Frame
    12 Months
    Secondary Outcome Measure Information:
    Title
    Distance-corrected near ETDRS LogMar visual acuity
    Description
    Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm
    Time Frame
    12 Months
    Title
    Distance-corrected near ETDRS LogMar visual acuity vs control
    Description
    Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group
    Time Frame
    12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Key Inclusion Criteria: 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 Other inclusion criteria specified in the protocol may apply. Key Exclusion Criteria: 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.) Other exclusion criteria specified in the protocol may apply.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patrick R Casey, O.D.
    Phone
    (949) 472-5112
    Email
    info@lensgen.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick R Casey, O.D.
    Organizational Affiliation
    LensGen, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35297798
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    http://lensgen.com
    Description
    Company website

    Learn more about this trial

    Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

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