Comparison of Visual Function of Enhanced Monofocal Intraocular Lenses After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Distance-corrected intermediate visual acuity
研究概览
简要总结
Comparison of the visual function of two enhanced monofocal intraocular lenses after cataract surgery
详细描述
Cataracts remain the leading cause of preventable blindness in many developing countries. Over the past decades, cataract surgery has undergone significant advancements. With the development of refined surgical techniques, such as smaller incisions, and the introduction of advanced intraocular lens (IOL) technologies, the procedure has transformed into a refractive approach for visual rehabilitation. The primary goal is to achieve a high level of spectacle independence for patient.
Monofocal lenses are designed with a single fixed focal length and refractive power. While they provide excellent distance vision, patients still need glasses for intermediate and near vision. However, modern patients have increasingly high expectations, often seeking full independence from spectacles after cataract surgery. This growing demand has fueled ongoing research and innovation in the development of advanced IOLs. In contrast, enhanced monofocal IOLs offer optical properties that deliver good intermediate vision outcomes without the negative aspects of multifocal IOLs such as photic phenomena or loss in contrast vision.
The aim of the study is therefore to compare two refractive enhanced monofocal IOLs in an intra-individual approach.
60 eyes of 30 patients will be included into this study. After randomization one eye is implanted with the Art 25 IOL, whereas the other eye gets the Eyhance IOL. Follow-up visits will be 1 week and 3 months after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age-related bilateral cataract
- •Age 21 or older
- •Visual acuity > 0.05
- •Axial length: 21.00-27.00mm
- •Astigmatism < 1.0 dpt
- •Normal findings in the medical history and physical examination
- •Written informed consent prior to surgery
排除标准
- •Reduced contrast vision, binocularity or stereoscopic vision (e.g. amblyopia, strabismus)
- •Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post- operative visual acuity
- •Relevant other ophthalmic diseases such as pseudoexfoliation syndrome
- •Irregular astigmatism on corneal tomography
- •Pronounced dry eye disease
- •Nystagmus or pathologies that might affect patient's fixation
- •Previous ocular surgery or trauma
- •Persons who are pregnant or nursing
结局指标
主要结局
Distance-corrected intermediate visual acuity
时间窗: 3 months
The difference in distance-corrected intermediate visual acuity before and after surgery will be measured at 66 cm and compared between the two different IOLs
次要结局
- Corrected and uncorrected distance visual acuity(3 months)
- Corrected and uncorrected near visual acuity(3 months)
- Uncorrected intermediate visual acuity(3 months)
- Defocus curve(3 months)
- Contrast Sensitivity(3 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery