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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Wojciech Lubiński
- Número de telefone: +48 91 466 12 93
- E-mail: oko@pum.edu.pl
Estude backup de contato
- Nome: Zuzanna Warenik
- Número de telefone: +48 91 466 12 93
- E-mail: z.warenik@usk2.szczecin.pl
Locais de estudo
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Zachodnipomorskie
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Szczecin, Zachodnipomorskie, Polônia, 70-111
- Recrutamento
- II Department of Ophthalmology, Pomeranian Medical University
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Contato:
- Wojciech Lubiński
- Número de telefone: +48 91466 12 93
- E-mail: oko@pum.edu.pl
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Visual function at distance, intermediate, and near ranges.
Prazo: 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.
Prazo: 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.
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Binocular contrast sensitivity.
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- enVista Envy
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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