Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens

Cataract Clinical Trial

— Nirvana  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05364983
• Other study ID #: CP20-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: November 2026

Study information

• Verified date: May 2022
• Source: LensGen, Inc.
• Contact: Patrick R Casey, O.D.
• Phone: (949) 472-5112
• Email: info[@]lensgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: November 2026
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Presbyopia

Intervention

Device:
• Juvene IOL
Cataract extraction and implantation of a posterior chamber IOL
• Tecnis® Monofocal (ZCB00, PCB00 or DCB00)
Cataract extraction and implantation of a posterior chamber IOL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LensGen, Inc.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance-corrected intermediate ETDRS LogMar visual acuity	Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm	12 Months
Primary	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
Primary	Defocus curve testing with ETDRS chart	Monocular diopters of depth of focus (DOF)	12 Months
Primary	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
Primary	Best corrected distance ETDRS LogMar visual acuity	Monocular photopic best corrected distance visual acuity (BCDVA)	12 Months
Secondary	Distance-corrected near ETDRS LogMar visual acuity	Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm	12 Months
Secondary	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

External Links

•   Company website