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NCT Number: NCT05364983

Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Juvene IOL

Device

Cataract extraction and implantation of a posterior chamber IOL

Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

Device

Cataract extraction and implantation of a posterior chamber IOL

Primary outcomes

  1. Distance-corrected intermediate ETDRS LogMar visual acuity

    Time frame: 12 Months

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

  2. Distance-corrected intermediate ETDRS LogMar visual acuity vs Control

    Time frame: 12 Months

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

  3. Defocus curve testing with ETDRS chart

    Time frame: 12 Months

    Monocular diopters of depth of focus (DOF)

  4. Best corrected distance ETDRS LogMar visual acuity vs control

    Time frame: 12 Months

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

  5. Best corrected distance ETDRS LogMar visual acuity

    Time frame: 12 Months

    Monocular photopic best corrected distance visual acuity (BCDVA)

Secondary outcomes

  1. Distance-corrected near ETDRS LogMar visual acuity

    Time frame: 12 Months

    Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm

  2. Distance-corrected near ETDRS LogMar visual acuity vs control

    Time frame: 12 Months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick R Casey, O.D.

CONTACT

[email protected]

(949) 472-5112

Sponsors and collaborators

Lead sponsor

LensGen, Inc.

Industry

Registry information

Official study title

A Prospective, Randomized, Controlled, Double-Masked, Phased, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of the LensGen® Juvene® Intraocular Lens

Acronym: Nirvana

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
May 6, 2022
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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