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Not yet recruitingNCT05364983NirvanaUpdated Mar 9, 2023

Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

An interventional study of Juvene IOL and Tecnis® Monofocal (ZCB00, PCB00 or DCB00) in Cataract and Presbyopia, sponsored by LensGen, Inc.. Not yet recruiting. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-09.

Sponsored by LensGen, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

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.

02

Conditions studied

  • Cataract
  • Presbyopia
03

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Care provider)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    Investigational IOL

    Juvene® IOL

    Device: Juvene IOL

  • Active comparator
    Control IOL

    Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

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

Interventions

  • DeviceJuvene IOL

    Cataract extraction and implantation of a posterior chamber IOL

  • DeviceTecnis® Monofocal (ZCB00, PCB00 or DCB00)

    Cataract extraction and implantation of a posterior chamber IOL

05

What researchers measure

Primary outcomes

  1. Distance-corrected intermediate ETDRS LogMar visual acuity

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

    Time frame: 12 Months

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

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

    Time frame: 12 Months

  3. Defocus curve testing with ETDRS chart

    Monocular diopters of depth of focus (DOF)

    Time frame: 12 Months

  4. Best corrected distance ETDRS LogMar visual acuity vs control

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

    Time frame: 12 Months

  5. Best corrected distance ETDRS LogMar visual acuity

    Monocular photopic best corrected distance visual acuity (BCDVA)

    Time frame: 12 Months

Secondary outcomes

  1. Distance-corrected near ETDRS LogMar visual acuity

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

    Time frame: 12 Months

  2. 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

    Time frame: 12 Months

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 35297798 ↗

Related links

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05364983
Lead sponsor
LensGen, Inc.
Responsible party
Sponsor
First posted
May 6, 2022
Start date
May 2023 (estimated)
Primary completion
Nov 2024 (estimated)
Completion
Nov 2026 (estimated)
Last update
Mar 9, 2023

Study contacts

Patrick R Casey, O.D.
Contact
info@lensgen.com
(949) 472-5112
Patrick R Casey, O.D.
study director · LensGen, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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