RecruitingNot ApplicableNCT05955846

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


Sponsor

Z Optics, Inc.

Enrollment

60 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called cataract surgery and implantation of device IOL FG-80030.1 for people with cataract, intraocular lens, and other related conditions. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREcataract 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

DEVICEimplantation 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


Locations(8)

Portugal Site 2

Coimbra, Portugal

Portugal Site 3

Lisbon, Portugal

Oftalvist Alicante

Alicante, Spain

Ceuta Medical Center

Ceuta, Spain

Hospital Arruzafa

Córdoba, Spain

Oftalvist Madrid

Madrid, Spain

Augenclinic Mallorca

Palma de Mallorca, Spain

Orasis

Reinach, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05955846


Related Trials