Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Neuroadaptation time.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Neuroadaptation time.
时间窗: From surgery to 6 months postoperatively.
Reduction in the time required for neuroadaptation following bilateral implantation of the enVista Envy IOL.
Visual function at distance, intermediate, and near ranges.
时间窗: 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.
Intraoperative and postoperative complications.
时间窗: From surgery to 6 months postoperatively.
Assessment of adverse events and complications associated with cataract surgery and implantation of the enVista Envy IOL.
次要结局
- Binocular contrast sensitivity.(Preoperatively and at 1, 3, and 6 months postoperatively.)
- Quality of vision and Near vision-related quality of life assessed using Questionnaires(At 1, 3, and 6 months postoperatively.)
- Incidence and severity of photic phenomena.(At 1, 3, and 6 months postoperatively.)
- Spectacle independence.(At 1, 3, and 6 months postoperatively.)