Comparison Between Bilateral Extended Depth of Focus (EDOF) Intraocular Lens Myopic Monovision and Monofocal Intraocular Lens Myopic Monovision for Myopic Patients: a Randomised Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Spectacle independence
研究概览
简要总结
Comparison of EDOF IOLs versus monofocal IOLs with mini-monovision concerning intermediate and near visual acuity.
详细描述
Spectacle independence is one of the main aims in modern cataract surgery. Although bilateral monofocal IOL implantation, aiming for emmetropia or low myopia, leads to high levels of patient satifsfaction in distance vision, spectacle dependence for reading and other near vision tasks is the usual result.
There are different techniques to reduce spectacle dependence, the most common one is the use of multifocal IOLs. However, a variable number of patients complain of problems, such as glare or haloes. It appears that multifocal IOL technology does lead to less satisfying results in patients with pre-operative myopia. These patients are used to very good near vision when taking off their spectacles. Many of these patients would prefer to keep their distance spectacles and ideally would like to function well at intermediate and near distance without glasses for e.g. reading and computer- or household work.
One option to enhance intermediate vision and to leave patients with good contrast sensitivity is the use of extended depth of focus (EDOF) IOLs. One example is the ACUNEX Vario AN6V with a near add of 1.50 D. In particular, this design provides improved vision at a distance of 66 cm and more. Additional key features of the low-add IOL include good contrast sensitivity for twilight vision, optimized depth of focus, and natural imaging quality and color sensitivity.
Another option to allow spectacle independence is (mini-)monovision. For some people, who are in need of intermediate and near reading vision most of the time, mini-monovision with one eye having intermediate (arms length) and one eye having near (reading) vision is a good option ("myopic monovision").
Hence, the aim of the study is to analyse intermediate and near vision outcomes in myopic patients with either EDOF IOLs or monofocal IOLs with mini-monovision.
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 cataract in both eyes
- •bilateral cataract surgery
- •motivated to be less spectacle dependent in the intermediate to near vision range
- •expected CDVA of 0.8 snellen or better
- •myopic patients with shorter eye having an axial length of at least 25.5 mm
- •age 21 and older
- •planned postoperative astigmatis lower than or 0.75 D
- •written informed consent prior to recruitment
排除标准
- •pregnancy (pregnancy test will be taken pre-operatively in women of reproductive age)
- •retinitis pigmentosa
- •chronic uveitis
- •amblyopia
- •pupil decentration > 0.8 mm, pupil size < 2.8 mm
- •preceded retinal surgery
- •preceded LASIK
- •any ophthalmic abnormality that could compromise visual function or the measurements
结局指标
主要结局
Spectacle independence
时间窗: 24 months
Spectacle independence will be assessed using a questionnaire and compared between patients with EDOF IOLs and patients with the monofocal IOL
次要结局
- Reading speed(24 months)
- Visual acuity(24 months)
- Stereo vision(24 months)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery
