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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Wojciech Lubiński
- Номер телефона: +48 91 466 12 93
- Электронная почта: oko@pum.edu.pl
Учебное резервное копирование контактов
- Имя: Zuzanna Warenik
- Номер телефона: +48 91 466 12 93
- Электронная почта: z.warenik@usk2.szczecin.pl
Места учебы
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Zachodnipomorskie
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Szczecin, Zachodnipomorskie, Польша, 70-111
- Рекрутинг
- II Department of Ophthalmology, Pomeranian Medical University
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Контакт:
- Wojciech Lubiński
- Номер телефона: +48 91466 12 93
- Электронная почта: oko@pum.edu.pl
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 20 patients (40 eyes)
Patients who meet all inclusion criteria and none of the exclusion criteria.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Visual function at distance, intermediate, and near ranges.
Временное ограничение: 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.
Временное ограничение: 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.
Временное ограничение: From surgery to 6 months postoperatively.
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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.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Binocular contrast sensitivity.
Временное ограничение: Preoperatively and at 1, 3, and 6 months postoperatively.
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Assessment of binocular contrast sensitivity under photopic and mesopic conditions.
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Preoperatively and at 1, 3, and 6 months postoperatively.
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Quality of vision and Near vision-related quality of life assessed using Questionnaires
Временное ограничение: At 1, 3, and 6 months postoperatively.
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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.
Временное ограничение: 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.
Временное ограничение: At 1, 3, and 6 months postoperatively.
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Assessment of participants' need for spectacles for distance, intermediate, and near vision tasks.
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At 1, 3, and 6 months postoperatively.
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- enVista Envy
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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