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Clinical Trials in Portugal / NCT05955846
Recruiting Not applicable

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

NCT05955846 · tracked via the Priya Life Science Portugal tracker
Sponsor
Z Optics, Inc
Phase
Not applicable
Started
2025-08-07
Last updated
2026-09-18

Condition(s) studied

Intraocular LensCataractPresbyopia

Investigational drug(s) / intervention(s)

cataract surgeryimplantation of device IOL FG-80030.1

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

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

Study 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

Sex
ALL
Min age
40 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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; 2. Preoperative best-corrected distance visual acuity (BCDVA) worse than 20/30 Snellen; 3. Clear intraocular media, other than cataract; 4. Calculated lens power within the available range (available range of +16 D to +24 D); 5. Preoperative keratometric astigmatism of less than 0.75 D in both operative eyes; 6. Potential for postoperative BCDVA of 20/25 or better in each eye after cataract removal and IOL implantation; 7. Able to comprehend and have signed a statement of informed consent; 8. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits; Exclusion Criteria: 1. Desire for monovision correction 2. 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) 3. Active or recurrent anterior segment pathology (chronic uveitis, iritis, iridocyclitis, rubeosis iridis, Reiter's syndrome, etc.); 4. 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; 5. Previous corneal or intraocular surgery; 6. Irregular corneal astigmatism; or regular corneal astigmatism greater than or equal to +/-0.75D; 7. Inability to achieve stable keratometric readings for contact lens wearers; \*The recommended time for discontinued wear of extended-wear or daily wear soft lenses is one week prior to surgery, one month for gas permeable and six months for PMMA lenses. No evidence of significant corneal warpage from contact lens use should be present on corneal topography and if the subject has been wearing a rigid gas permeable contact lens there should be two stable serial topographies at least 1 month following cessation of contact lens wear 8. Higher-order Zernike corneal aberrations (3rd -order and above) RMS value greater than 1.0 um for the central 6-mm diameter area; 9. Pupil dilation in scotopic conditions \>5mm 10. Use of systemic or ocular medications that may affect vision or likely to impact pupil dilation or iris structure; 11. Pharmacologically dilated pupil size less than 6 mm in either eye; 12. Pupil abnormalities; 13. History of ocular trauma, prior refractive or other ocular surgery or subjects expected to require retinal laser treatment or other surgical intervention; 14. Any disease or pathology, other than cataract, that (in the expert opinion of the Investigator) is expected to reduce the potential postoperative BCDVA. Note: Conditions including, but not limited to the following: amblyopia, clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), diabetic retinopathy, extremely shallow anterior chamber, not due to swollen cataract, microphthalmos, previous retinal detachment, previous corneal transplant, recurrent severe anterior or posterior segment inflammation of unknown etiology, iris; neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy, or diagnosis of pseudoexfoliation; 15. Neovascularization, uncontrolled glaucoma, aniridia, or optic nerve atrophy; 16. Subjects who have profound sensitivity to glare at night with oncoming traffic headlights or subjects who are sensitive to fluorescent light flicker; 17. Subjects who may reasonably be expected to require a SSI at any time during the study (other than YAG capsulotomy); 18. Subject is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye. Females of childbearing age must have a negative pregnancy test at screening in order to be enrolled into the study. 19. Concurrent participation or participation in any clinical trial up to 30 days prior to preoperative visit; 20. Acute, chronic, or uncontrolled systemic or ocular disease or any illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., poorly-controlled diabetes);

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Portugal Site 2 Coimbra Portugal Recruiting
Portugal Site 3 Lisbon Portugal Not Yet Recruiting
Oftalvist Alicante Alicante Spain Recruiting
Ceuta Medical Center Ceuta Spain Recruiting
Hospital Arruzafa Córdoba Spain Recruiting
Oftalvist Madrid Madrid Spain Recruiting
Augenclinic Mallorca Palma de Mallorca Spain Recruiting
Orasis Reinach Switzerland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05955846 on ClinicalTrials.gov ↗ ← All trials in Portugal