Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens (Nirvana)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract; Presbyopia
• Intervention / Treatment: Device: Juvene IOL; Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick R Casey, O.D.; Phone Number: (949) 472-5112; Email: info@lensgen.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: LensGen, Inc.
• Investigators: Study Director: Patrick R Casey, O.D., LensGen, Inc.

Publications and helpful links

General 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.

Helpful Links

• Company website

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2026

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: CP20-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes