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Not yet recruiting NCT05364983

Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

No phase Interventional Cataract Presbyopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Juvene IOL, Tecnis® Monofocal (ZCB00, PCB00 or DCB00).
Who it may be relevant to
Registry conditions: Cataract, Presbyopia. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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

Primary outcome measures

  • Distance-corrected intermediate ETDRS LogMar visual acuity [Time frame: 12 Months]
  • Distance-corrected intermediate ETDRS LogMar visual acuity vs Control [Time frame: 12 Months]
  • Defocus curve testing with ETDRS chart [Time frame: 12 Months]
  • Best corrected distance ETDRS LogMar visual acuity vs control [Time frame: 12 Months]
  • Best corrected distance ETDRS LogMar visual acuity [Time frame: 12 Months]
Secondary outcome measures (2)
  • Distance-corrected near ETDRS LogMar visual acuity [Time frame: 12 Months]
  • Distance-corrected near ETDRS LogMar visual acuity vs control [Time frame: 12 Months]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 35297798

Identifiers

NCT: NCT05364983 · CP20-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗