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Een prospectief klinisch onderzoek in meerdere centra om de veiligheid en effectiviteit van een IOL met een virtuele diafragmaoptiek te evalueren

14 september 2026 bijgewerkt door: Z Optics, Inc.

Een prospectief klinisch onderzoek in meerdere centra om de veiligheid en effectiviteit van een intraoculaire lens met een optiek met virtuele opening te evalueren

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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);

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Z+ VAO IOL

FG-80030.1 hydrophobic
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

Apparaat: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Binocular photopic uncorrected visual acuity
Tijdsspanne: 6 months
  • Binocular photopic uncorrected visual acuity at 6-months at 4 meters (infinity): uncorrected distance visual acuity (UDVA).
  • Binocular photopic uncorrected visual acuity at 6-months at 4 meters (infinity) at 66 cm (intermediate): uncorrected intermediate visual acuity (UIVA).
  • Binocular photopic uncorrected visual acuity at 6-months at 4 meters (infinity) at 1.5 meters (intermediate walking visual acuity): uncorrected walking visual acuity (UWVA)
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Efficacy : Binocular defocus/depth of focus curve
Tijdsspanne: 3 months

Binocular defocus/depth of focus curve under photopic conditions at the 3-month visit. Depth of Focus is calculated as the mean binocular diopters of range of focus where the visual acuity is 20/40 or better. The depth of focus will be measured at 66 cm, using the UIVA as the starting point. Defocus will be measured in 0.50D steps from +1.5D of positive defocus to -2.5D of negative defocus.
3 months
Efficacy : Uncorrected Visual Acuity
Tijdsspanne: 6 months

3 meters (TV viewing distance): uncorrected TV visual acuity (UTVVA) at 6 months.
6 months
Efficacy : Visual Acuity
Tijdsspanne: 1 month
  • VA under mesopic conditions at 1.5m using ETDRS charts.
  • VA under mesopic conditions at 66cm using ETDRS charts.
1 month
Efficacy : Continuous-objective visual assessment by Vivior defocus curves
Tijdsspanne: 12 Months

Continuous-objective visual assessment: Measured with Vivior Visual Behavior monitor and assessed with the Vivior defocus curves to compare post-operative vs pre-operative visual requirements
12 Months
Efficacy : Patient questionnaire
Tijdsspanne: 12 Months

Patient reported outcomes: Near Activity Visual Questionnaire (NAVQ)

Questions related to the difficulty of the patient to perform tasks at near distance. Evaluation is rated on a scale from 0 to 3 defined as follows :

0 : No difficulty

  1. : A little difficulty
  2. : Moderate difficulty
  3. : Extrement difficulty
12 Months
Safety - Best corrected visual acuity
Tijdsspanne: 1 month

Loss of 10 letters or more of BCDVA when compared to Loss of 10 letters or more of BCDVA when compared to Preoperative or Postop Month 1.
1 month
Safety : Visual Acuity
Tijdsspanne: 1 month
  • VA under mesopic conditions at 1.5 m.
  • VA under mesopic conditions at 66cm.
1 month
Safety : Percentage of patient with visual disturbances
Tijdsspanne: 12 Months

Assessment of visual disturbances at 6-month visit using either the Glare/Halo simulator and/or an objective assessment of Visual Disturbance
12 Months
Safety : secondary surgical interventions
Tijdsspanne: 12 Months

The cumulative rate of secondary surgical interventions (SSIs) related to the optical properties of the IOL
12 Months
Safety : Intraocular Pressure (IOP)
Tijdsspanne: 12 Months

Intraocular Pressure (IOP)
12 Months
Safety : Slit Lamp Examination
Tijdsspanne: 12 Months
  • Evaluation of Lens centration.
  • Evaluation of lens tilt.
  • Examination of capsule.
  • Examination of striae ratings.
12 Months
Safety : slit lamp observations
Tijdsspanne: 12 Months

IOL Observations including Posterior Capsule Opacification
12 Months
Safety : Rate of Posterior Capsulotomy
Tijdsspanne: 12 Months

Rate of Posterior Capsulotomy
12 Months
Safety : Slit lamp Fundus Visualization
Tijdsspanne: 12 Months

Fundus Visualization
12 Months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Z Optics, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 augustus 2025

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

3 juli 2023

Eerst ingediend dat voldeed aan de QC-criteria

12 juli 2023

Eerst geplaatst (Werkelijk)

21 juli 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VAO-IOL-004

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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