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NOT YET RECRUITING
NCT05955846
NA

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

Sponsor: Z Optics, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-03-01

Completion Date

2025-09

Last Updated

2025-01-27

Healthy Volunteers

No

Interventions

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