Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular Lenses
The enVista Envy intraocular lens (IOL) manufactured by Bausch + Lomb is a new multifocal intraocular lens based on diffractive optics. It was registered with the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in September 2025. The lens also bears the CE mark, indicating that it is approved for marketing and use within the European Union.
Its innovative design is based on a smooth, continuous transition between diffractive rings, allowing patients to achieve excellent visual quality at far, intermediate, and near distances while reducing the incidence and severity of unwanted photic phenomena such as glare and halos. Thanks to this technology, patients may achieve better uncorrected visual acuity, reduced dependence on spectacles, and faster neuroadaptation.
The Second Department of Ophthalmology is the first center in Poland to be offered participation in a clinical study evaluating the safety and effectiveness of the enVista Envy IOL. The planned study will provide the first clinical experience with this lens in Poland and contribute to expanding knowledge regarding modern intraocular lens technologies.
Twenty patients will be selected according to predefined inclusion and exclusion criteria. Preoperative assessment will include a comprehensive ophthalmic examination and IOL power calculation. Cataract surgery will be performed using bimanual MICS (Micro-Incision Cataract Surgery) phacoemulsification. Surgery in the fellow eye will be performed one month after the first procedure.
Before surgery and during follow-up visits at 1, 3, and 6 months postoperatively, the following assessments will be performed: routine ophthalmic examination, intraocular pressure (IOP) measurement, visual evoked potentials (VEP), monocular and binocular uncorrected distance visual acuity (UDVA), distance best-corrected visual acuity (DBCVA) at 4 meters, intermediate visual acuity (66 cm) and near visual acuity (40 cm), both corrected and uncorrected, monocularly and binocularly (logMAR charts), binocular contrast sensitivity testing, and defocus curve assessment.
Intraoperative and postoperative complications, quality of vision (using the standardized Quality of Vision Questionnaire [QoV] and the Near Activity Vision Questionnaire [NAVQ]), speed of neuroadaptation, spectacle independence, and the occurrence of photic phenomena such as glare and halos will also be analyzed.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Wojciech Lubiński
- Numéro de téléphone: +48 91 466 12 93
- E-mail: oko@pum.edu.pl
Sauvegarde des contacts de l'étude
- Nom: Zuzanna Warenik
- Numéro de téléphone: +48 91 466 12 93
- E-mail: z.warenik@usk2.szczecin.pl
Lieux d'étude
-
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Zachodnipomorskie
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Szczecin, Zachodnipomorskie, Pologne, 70-111
- Recrutement
- II Department of Ophthalmology, Pomeranian Medical University
-
Contact:
- Wojciech Lubiński
- Numéro de téléphone: +48 91466 12 93
- E-mail: oko@pum.edu.pl
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Bilateral cataract or refractive lens exchange candidates.
- Presbyopia and/or hyperopia.
- Preoperative corneal astigmatism less than 1.00 diopter (D).
- Absence of ocular diseases other than cataract.
- High motivation to achieve spectacle independence.
- Patients willing to accept the possibility of mild photic phenomena, such as glare and halos.
Exclusion Criteria:
Ocular Conditions:
- Glaucoma.
- Amblyopia.
- Macular diseases (including macular degeneration and other macular pathology).
- Angle kappa greater than 0.5 mm.
- Dry eye disease.
- Corneal disorders.
- Pupil abnormalities.
- Irregular astigmatism.
- Ocular motility disorders or strabismus.
- Pupil diameter < 2.5 mm under photopic conditions or > 6.0 mm under mesopic conditions.
- Abnormalities of the capsular bag or zonular apparatus, including pseudoexfoliation syndrome (PEX).
Lifestyle Factors:
- Patients with unrealistic expectations regarding postoperative visual outcomes.
- Individuals whose professions require highly precise visual performance, such as pilots, professional drivers, architects, or similar occupations.
- Patients satisfied with using spectacles for near vision.
- Age greater than 75 years (due to potential difficulties with neuroadaptation to new visual conditions).
Psychological and Personality Factors:
- Patients with psychiatric disorders that may interfere with study participation or outcome assessment.
- Patients dissatisfied with progressive addition lenses (progressive spectacles).
- Patients with dyslexia or a history of stroke.
- Type A personality traits (perfectionists).
- Patients will also be excluded if the calculated IOL power falls outside the available range of +6.00 D to +34.00 D or if they have a history of laser vision correction surgery.
Plan d'étude
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: 20 patients (40 eyes)
Patients who meet all inclusion criteria and none of the exclusion criteria.
|
Surgery performed using the NGENUITY® 3D Visualization System.
Two-handed Micro-Incision Cataract Surgery (MICS) technique.
Corneal incisions measuring 1.2 × 1.4 mm at the 2 o'clock and 10 o'clock positions.
Continuous curvilinear capsulorhexis with a diameter of approximately 5 mm.
Ultrasound phacoemulsification.
Intraocular lens (IOL) implantation through a 2.2-2.3 mm incision.
The implanted intraocular lens (IOL) will be the enVista Envy IOL.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual function at distance, intermediate, and near ranges.
Délai: Preoperatively and at 1, 3, and 6 months postoperatively.
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Improvement in visual function at distance (4 m), intermediate (66 cm), and near (40 cm) distances following bilateral implantation of the enVista Envy IOL.
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Preoperatively and at 1, 3, and 6 months postoperatively.
|
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Neuroadaptation time.
Délai: From surgery to 6 months postoperatively.
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Reduction in the time required for neuroadaptation following bilateral implantation of the enVista Envy IOL.
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From surgery to 6 months postoperatively.
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Intraoperative and postoperative complications.
Délai: From surgery to 6 months postoperatively.
|
Assessment of adverse events and complications associated with cataract surgery and implantation of the enVista Envy IOL.
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From surgery to 6 months postoperatively.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Binocular contrast sensitivity.
Délai: Preoperatively and at 1, 3, and 6 months postoperatively.
|
Assessment of binocular contrast sensitivity under photopic and mesopic conditions.
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Preoperatively and at 1, 3, and 6 months postoperatively.
|
|
Quality of vision and Near vision-related quality of life assessed using Questionnaires
Délai: At 1, 3, and 6 months postoperatively.
|
Evaluation of subjective visual quality, including frequency, severity, and bothersomeness of visual disturbances - Quality of Vision (QoV) Questionnaire.
Evaluation of patient-reported ability to perform near-vision activities and overall satisfaction with near vision - The Near Activity Visual Questionnaire (NAVQ).
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At 1, 3, and 6 months postoperatively.
|
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Incidence and severity of photic phenomena.
Délai: At 1, 3, and 6 months postoperatively.
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Assessment of the occurrence and severity of photic phenomena reported by participants.
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At 1, 3, and 6 months postoperatively.
|
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Spectacle independence.
Délai: At 1, 3, and 6 months postoperatively.
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Assessment of participants' need for spectacles for distance, intermediate, and near vision tasks.
|
At 1, 3, and 6 months postoperatively.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- enVista Envy
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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