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

RecruitingNAAges 50 Years - 75 YearsAllPomeranian Medical University Szczecin
NCT07696130 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • cataract surgery
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Where

1 site
II Department of Ophthalmology, Pomeranian Medical University
Szczecin, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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