Difference in Visual Performance of a Refractive Extended Depth of Focus Intraocular Lens in an Emmetropic or Monovision Modality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Corrected and uncorrected binocular visual acuity for near distance
研究概览
简要总结
Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality
详细描述
With an expanding market of different types of intraocular lenses (IOL), spectacle independence is a rising aim in modern cataract surgery. The procedure has in many cases changed from a vision restoring to a presbyopia correcting approach. 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 at intermediate distance (e.g., PC work) is the implantation of enhanced depth of focus (EDOF) IOLs. 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 spectrum ranges from small aperture design, bioanalogic design, to diffractive and non-diffractive optics. The disadvantage compared to monofocal lenses in all the technologies mentioned is the potentially worse distance vision and contrast sensitivity as well as dysphotopsia.
A new refractive EDOF lens segment with an extended depth of vision was introduced which promises an increased range of functional vision and less dysphotopsias compared to diffractive EDOF lenses. These non-diffractive IOLs are believed to be a presbyopia correcting alternative for people with existing corneal or macula pathologies, which would preclude them from receiving premium lenses because of the loss of light in the diffractive process. To increase spectacle independence for these patients, IOLs may be used in a monovision modality, with an offset of up to 1.5dpt. This method showed good results in the literature so far for monofocal and multifocal intraocular lenses.
Aim of the study is to compare a new non-diffractive EDOF-IOL, namely the PureSee, set for emmetropia or monovision.
120 eyes of 60 patients will be included into this study. Patients will be either randomized in the emmetropia or the monovision group
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
- •Written informed consent prior to surgery
排除标准
- •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 (PEX)
- •Irregular astigmatism on corneal tomography
- •Pronounced dry eye disease
- •Previous ocular surgery or trauma
- •Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
结局指标
主要结局
Corrected and uncorrected binocular visual acuity for near distance
时间窗: 12 months
Corrected and uncorrected binocular visual acuity for near distance will be assessed at 40 cm using ETDRS charts
次要结局
- Corrected and uncorrected binocular visual acuity for distance(12 months)
- Corrected and uncorrected binocular visual acuity for intermediate distance(12 months)
- Contrast sensitivity(12 months)
- Subjective quality of vision(12 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery