Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

Not Applicable

Not yet recruiting

• Conditions: Presbyopia; Cataract
• Interventions: Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00); Device: Juvene IOL

• Registration Number: NCT05364983
• Lead Sponsor: LensGen, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-06
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09
• Study Start: 2023-05
• Primary Completion: 2024-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control IOL	Tecnis® Monofocal (ZCB00, PCB00 or DCB00)	Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Investigational IOL	Juvene IOL	Juvene® IOL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Distance-corrected near ETDRS LogMar visual acuity	12 Months	Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm
Distance-corrected near ETDRS LogMar visual acuity vs control	12 Months	Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group