Performance of Two Non-diffractive Intraocular Lenses With Extended Depth of Vision Set for Mini-monovision
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Visual acuity at intermediate distance
研究概览
简要总结
Comparison of the capsular bag performance of two extended depth of vision (EDOF) intraocular lenses (IOLs), the Rayone EMV and the Alcon Acrysof IQ Vivity, in a mini-monovision setting
详细描述
Spectacle independence is a rising aim in modern cataract surgery. Although bilateral monofocal IOL implantation, aiming for emmetropia leads to high levels of patient satisfaction for distance vision, spectacle dependence for reading and intermediate vision tasks is the usual result.
The option commonly used to achieve spectacle independence in all distances are multifocal intraocular lenses. One concept of multifocality is the trifocal lens. This lens provides good vision in three focal distances: far, intermediate, and near. However, one potential disadvantage of trifocal IOLs is slightly poorer near vision with need for reading gasses for prolonged fine near work and loss of contrast sensitivity in the intermediate distance.
A better intermediate performance concerning contrast vision compared to trifocal IOLs can be reached using enhanced depth of focus (EDOF) lenses. These IOLs have an extended far focus area, which reaches to the intermediate distance, providing high-quality vision over a continuous range of focus, rather than distinct foci with blur in between. In the last years several technologies for EDOF IOLs appeared on the market. The disadvantage compared to monofocal lenses in all of these technologies is the potentially worse contrast sensitivity as well as dysphotopsia.
A new monofocal non-diffractive lens with an extended depth of vision (Rayone EMV) promises an increased range of functional vision and less dysphotopsias. Especially in a monovision setting, where the dominant eye is set for emmetropia and the other eye for low myopia is believe dto be a promising concept for spectacle independence.
Hence, the aim of this study is to compare a new monofocal IOL wit a non-diffractive extended depth of vision (Rayone EMV) with an already established non-diffractive EDOF IOL (Alcon Acrysof IQ Vivity) in a mini-monovision setting.
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: 22.0 - 26.0 mm
- •normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •written informed consent prior to surgery
排除标准
- •active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
- •relevant othe rophthalmic diseases such as pseudoexfoliation syndrome (PEX), intraoperative floppy iris syndrome (IFIS)
- •corneal decompensation or corneal endothelial cell insufficiency
- •previous ocular surgery or trauma
- •persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
- •corneal astigmatism > 1 dpt.
- •retinopathies
结局指标
主要结局
Visual acuity at intermediate distance
时间窗: 24 months
The visual acuity at the intermediate distance will be measured using ETDRS charts at a distance of 80 centimetres and compared between the two different IOLs
次要结局
- Reading speed(24 months)
- Visual acuity at far distance(24 months)
- Visual acuity at near distance(24 months)
- Visual acuity in the defocus curve(24 months)
- Halometry(24 months)
- Contrast sensitivity(24 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery