Nirvana: Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

• Sponsor: LensGen, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05364983
• Collaborator: (none)
• Enrollment: 56
• Arms: 2
• Anticipated Duration (Months): 39

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Presbyopia	Device: Juvene IOL; Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: A prospective, randomized, controlled, double-masked, phased, multicenter clinical studyA prospective, randomized, controlled, double-masked, phased, multicenter clinical study
• Masking: Double (Participant, Care Provider)
• Masking Description: The subject will be masked to randomization assignment and will be unmasked at the completion of the study. Scheduled masked postoperative assessments will be performed by a masked examiner
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Distance-corrected intermediate ETDRS LogMar visual acuity [12 Months]

   Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm

2. 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

3. Defocus curve testing with ETDRS chart [12 Months]

   Monocular diopters of depth of focus (DOF)

4. 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

5. Best corrected distance ETDRS LogMar visual acuity [12 Months]

   Monocular photopic best corrected distance visual acuity (BCDVA)

Secondary Outcome Measures

1. Distance-corrected near ETDRS LogMar visual acuity [12 Months]

   Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• LensGen, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Company website

Publications

• Garg S, De Jesus MT, Laura MF, Chayet A, Barragán E, Casey P. Twelve-Month Clinical Outcomes After Implantation of a Novel, Modular, Anterior Shape-Changing Fluid Optic Intraocular Lens. J Cataract Refract Surg. 2022 Mar 16. doi: 10.1097/j.jcrs.0000000000000935. [Epub ahead of print]

• Responsible Party: LensGen, Inc.
• ClinicalTrials.gov Identifier: NCT05364983
• Other Study ID Numbers: CP20-001
• First Posted: May 6, 2022
• Last Update Posted: May 16, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cataract; Presbyopia

Study Results

No Results Posted as of May 16, 2022