NCT05364658

A Clinical Evaluation of the LensGen Intraocular Lens

A Clinical Evaluation of the Safety and Efficacy of the LensGen Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: LensGen, Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

A multi-center, open-label, non-comparative clinical trial to assess the safety and efficacy of the LensGen IOL (Juvene IOL) for the treatment of aphakia and presbyopia after removal of the natural crystalline lens due to cataract.

Detailed description

The Juvene IOL is specifically designed to utilize the mechanics of two optics to change the focal point in the human eye to correct presbyopia without the side effects experienced with other presbyopia correcting lenses. One optic provides the base power of the lens. The other contains a central fluid reservoir that utilizes the natural contraction of the ciliary body to change the focal point of the eye via the neural-uveal response induced by looking at an intermediate or near target. The optic material is well characterized and has been safely used as an IOL material. Diffractive and refractive multifocal IOLs provide functional distance and near vision, with up to 4 diopters of add, yet they have not overcome the known side effects of haloes, glare, and reduced contrast sensitivity. Newer presbyopia correcting lenses, such as the Juvene IOL, use novel and proprietary changes in lens curvature to bilaterally change the focal point in each eye to any given distance the patient is looking.

Conditions

• Cataract
• Presbyopia

Interventions

Type	Name	Description
DEVICE	Juvene IOL	Indicated for Implantation in the human eye after removal of a cataractous crystalline lens

Timeline

• Start date: 2018-11-18
• Primary completion: 2019-11-30
• Completion: 2020-01-30
• First posted: 2022-05-06
• Last updated: 2023-03-09

Locations

2 sites across 1 country: Mexico