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Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular Lenses

8. juli 2026 oppdatert av: Pomeranian Medical University Szczecin

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Wojciech Lubiński
  • Telefonnummer: +48 91 466 12 93
  • E-post: oko@pum.edu.pl

Studer Kontakt Backup

Studiesteder

  • Polen
    • Zachodnipomorskie
      • Szczecin, Zachodnipomorskie, Polen, 70-111
        • Rekruttering
        • II Department of Ophthalmology, Pomeranian Medical University
        • Ta kontakt med:
          • Wojciech Lubiński
          • Telefonnummer: +48 91466 12 93
          • E-post: oko@pum.edu.pl

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 20 patients (40 eyes)
Patients who meet all inclusion criteria and none of the exclusion criteria.
Enhet: cataract surgery
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual function at distance, intermediate, and near ranges.
Tidsramme: Preoperatively and at 1, 3, and 6 months postoperatively.
Improvement in visual function at distance (4 m), intermediate (66 cm), and near (40 cm) distances following bilateral implantation of the enVista Envy IOL.
Preoperatively and at 1, 3, and 6 months postoperatively.
Neuroadaptation time.
Tidsramme: From surgery to 6 months postoperatively.
Reduction in the time required for neuroadaptation following bilateral implantation of the enVista Envy IOL.
From surgery to 6 months postoperatively.
Intraoperative and postoperative complications.
Tidsramme: From surgery to 6 months postoperatively.
Assessment of adverse events and complications associated with cataract surgery and implantation of the enVista Envy IOL.
From surgery to 6 months postoperatively.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Binocular contrast sensitivity.
Tidsramme: Preoperatively and at 1, 3, and 6 months postoperatively.
Assessment of binocular contrast sensitivity under photopic and mesopic conditions.
Preoperatively and at 1, 3, and 6 months postoperatively.
Quality of vision and Near vision-related quality of life assessed using Questionnaires
Tidsramme: 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).
At 1, 3, and 6 months postoperatively.
Incidence and severity of photic phenomena.
Tidsramme: At 1, 3, and 6 months postoperatively.
Assessment of the occurrence and severity of photic phenomena reported by participants.
At 1, 3, and 6 months postoperatively.
Spectacle independence.
Tidsramme: At 1, 3, and 6 months postoperatively.
Assessment of participants' need for spectacles for distance, intermediate, and near vision tasks.
At 1, 3, and 6 months postoperatively.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pomeranian Medical University Szczecin

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2026

Primær fullføring (Antatt)

1. februar 2029

Studiet fullført (Antatt)

1. februar 2029

Datoer for studieregistrering

Først innsendt

24. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juli 2026

Først lagt ut (Faktiske)

10. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • enVista Envy

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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