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

LensGen

Status: Not yet enrolling

Conditions: Cataract; Presbyopia

Treatments: Device: Juvene IOL; Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05364983

CP20-001

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Investigational IOL

Experimental group

Description:

Juvene® IOL

Treatment:

Device: Juvene IOL

Control IOL

Active Comparator group

Description:

Tecnis® Monofocal (ZCB00, PCB00 or DCB00)

Treatment:

Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)