NCT05955846

Evaluation of Safety and Effectiveness of an IOL With a Virtual Aperture Optic

A Prospective Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of an Intraocular Lens With a Virtual Aperture Optic

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Z Optics, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Cataracts are cloudy areas in the lens of the eye that can cause changes in vision. Symptoms of cataracts include cloudy or fuzzy vision and sensitivity to glare. Cataract extraction with Intraocular lens (IOL) implantation is the most commonly performed surgical procedure in the world. Presbyopia affects almost everyone over the age of 50. With age, the natural crystalline lens loses its ability to change shape, or accommodate, to focus on near distances. Thus, individuals with excellent distance vision will still need to wear spectacles for near tasks such as reading, and intermediate tasks such as computer work.

Detailed description

The Z+ Virtual Aperture Optic IOL has been designed to perform similarly to monofocal IOL in that it corrects for distance vision but is also designed to provide a greater depth of focus. This greater depth of focus should improve near and intermediate visual acuities and thus reducing spectacle dependance. Therefore, it is expected that the Z+ Virtual Aperture Optic IOL will be a safe and efficient option for patients with presbyopia who desires spectacle independence after cataract surgery.

Conditions

• Intraocular Lens
• Cataract
• Presbyopia

Interventions

Type	Name	Description
PROCEDURE	cataract surgery	Subjects will undergo surgery to remove cataract (natural cloudy lens) via phacoemulsification implant the IOL Both eyes will be treated one month apart. Subjects will be followed up during 12 months
DEVICE	implantation of device IOL FG-80030.1	implant the IOL in both eyes. Both eyes will be treated one month apart. Subjects will be followed up during 12 months

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2023-07-21
• Last updated: 2025-01-27