Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract, Presbyopia

Intervention / Treatment
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* Device: Juvene IOL
* Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, randomized, controlled, double-masked, phased, multicenter clinical study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational IOL<br>Juvene® IOL | Device: Juvene IOL<br>* Cataract extraction and implantation of a posterior chamber IOL<br>|
| Active Comparator: Control IOL<br>Tecnis® Monofocal (ZCB00, PCB00 or DCB00) | Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)<br>* Cataract extraction and implantation of a posterior chamber IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance-corrected intermediate ETDRS LogMar visual acuity | Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm | 12 Months | 
| Distance-corrected intermediate ETDRS LogMar visual acuity vs Control | Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group | 12 Months | 
| Defocus curve testing with ETDRS chart | Monocular diopters of depth of focus (DOF) | 12 Months | 
| Best corrected distance ETDRS LogMar visual acuity vs control | Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group | 12 Months | 
| Best corrected distance ETDRS LogMar visual acuity | Monocular photopic best corrected distance visual acuity (BCDVA) | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance-corrected near ETDRS LogMar visual acuity | Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm | 12 Months | 
| 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 | 12 Months |