Health TrialsbyHealthPanel

Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

ConditionsCataractPresbyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorLensGen, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Investigational IOLExperimental treatment 1 intervention
Group B: Control IOLActive comparator 1 intervention

Trial outcomes

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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LensGen, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: