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Un essai clinique multicentrique prospectif pour évaluer la sécurité et l'efficacité d'une LIO avec une optique d'ouverture virtuelle

14 septembre 2026 mis à jour par: Z Optics, Inc.

Un essai clinique multicentrique prospectif pour évaluer la sécurité et l'efficacité d'une lentille intraoculaire avec une optique d'ouverture virtuelle

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Espagne
      • Alicante, Espagne
        • Recrutement
        • Oftalvist Alicante
        • Contact:
      • Ceuta, Espagne
      • Córdoba, Espagne
      • Madrid, Espagne
        • Recrutement
        • Oftalvist Madrid
        • Contact:
      • Palma de Mallorca, Espagne
  • Le Portugal
      • Coimbra, Le Portugal
      • Lisbon, Le Portugal
        • Pas encore de recrutement
        • Portugal Site 3
        • Contact:
          • Numéro de téléphone: +351 21 710 4400
  • Suisse
      • Reinach, Suisse
        • Recrutement
        • Orasis
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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);

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Z+ VAO IOL

FG-80030.1 hydrophobic
Procédure: 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

Dispositif: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Binocular photopic uncorrected visual acuity
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Efficacy : Binocular defocus/depth of focus curve
Délai: 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
Délai: 6 months

3 meters (TV viewing distance): uncorrected TV visual acuity (UTVVA) at 6 months.
6 months
Efficacy : Visual Acuity
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 12 Months

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

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

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

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

Fundus Visualization
12 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Z Optics, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 août 2025

Achèvement primaire (Estimé)

1 août 2027

Achèvement de l'étude (Estimé)

1 septembre 2027

Dates d'inscription aux études

Première soumission

3 juillet 2023

Première soumission répondant aux critères de contrôle qualité

12 juillet 2023

Première publication (Réel)

21 juillet 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • VAO-IOL-004

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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