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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Visual function at distance, intermediate, and near ranges. [Срок оценки: Preoperatively and at 1, 3, and 6 months postoperatively.]
• Neuroadaptation time. [Срок оценки: From surgery to 6 months postoperatively.]
• Intraoperative and postoperative complications. [Срок оценки: From surgery to 6 months postoperatively.]

Вторичные конечные точки (4)

• Binocular contrast sensitivity. [Срок оценки: Preoperatively and at 1, 3, and 6 months postoperatively.]
• Quality of vision and Near vision-related quality of life assessed using Questionnaires [Срок оценки: At 1, 3, and 6 months postoperatively.]
• Incidence and severity of photic phenomena. [Срок оценки: At 1, 3, and 6 months postoperatively.]
• Spectacle independence. [Срок оценки: At 1, 3, and 6 months postoperatively.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• II Department of Ophthalmology, Pomeranian Medical University — Szczecin

Идентификаторы

NCT: NCT07696130 · enVista Envy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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