Evaluation of Safety and Effectiveness of an IOL With a Virtual Aperture Optic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorZ Optics, Inc.
About this trial
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 criteria
Qualifiers
Adults, Age 40 to 75 years at the time of surgery, diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision and posterior chamber IOL implantation;
Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/30 Snellen;
Clear intraocular media, other than cataract;
Calculated lens power within the available range (available range of +16 D to +24 D);
Disqualifiers
Desire for monovision correction
History of Dry Eye treatments/devices (example IPL, Lipiflow, iLux, Tear Care, Bruder Mask, True Tear) or any dry eye medications other than artificial tears (example, Restasis, Xiidra, Cequa, Klarity-C, generic cyclosporine/compounded cyclosporine)
Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, Reiter's syndrome, etc.);
Clinically significant corneal abnormalities or defects including corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), irregularity (including irregularity due to dry eye syndrome), inflammation or edema per the Investigator's expert medical opinion. Note: conditions including, but not limited to: keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or keratectasia should be excluded;
Trial design
Treatments tested in this trial
- cataract surgery
- implantation of device IOL FG-80030.1
Treatment groups
60 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov