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临床试验/NCT03538964
NCT03538964Unknown不适用

Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism

Prim. Prof. Dr. Oliver Findl, MBA2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
2
主要终点
Subjective refraction to detect remaining astigmatism (in Diopters) between both groups

研究概览

简要总结

Comparison of the astigmatism reducing effect of a toric IOL with a non toric IOL in eyes with low corneal astigmatism.

详细描述

With increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more widely to cataract surgery. Originally, toric IOLs were used mainly for patients with high degrees of astigmatism. Since a couple of years, toric IOLs are available from numerous manufacturers to correct moderate amounts of astigmatism which are much more prevalent with about 8% having a corneal astigmatism of 2.0D or more in the cataract population. 5Using toric IOLs for these eyes results in less spectacle dependence of patients due to the astigmatic correction. Other astigmatism reducing techniques, such as peripheral corneal relaxing incisions and opposite clear corneal incisions were shown to be less predictable. Although the use of toric IOLs became the gold standard to correct corneal astigmatism during cataract surgery , there is still uncertainty, if low astigmatism should be corrected. Visser et al. showed that moderate astigmatism of than 1.5D should be corrected for monofocal IOLs and Hayashi showed that remaining astigmatism of 1.0D already decreases visual quality in eyes with multifocal IOLs. Although correction of low corneal astigmatism appears to be beneficial, some hurdles have to be taken into account. In eyes with low corneal astigmatism the accuracy of measuring the astigmatism meridian is relatively low. Furthermore, different corneal measurement techniques are not always comparable and it is difficult to know, which device shows the correct amount of astigmatism. Additionally, the correction of the spherical equivalent is of high importance, as a refractive surprise will also attenuate the astigmatism reducing effect of the toric IOL. Aim of this study is to assess, if toric IOLs are useful in patients with low amounts of corneal astigmatism and to quantify the sources of error in toric IOL power calculation.

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
None

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 21 and older
  • Regular corneal astigmatism 0.5D up to 1.5 D and difference between eyes not more than 0.75D
  • written informed consent prior to surgery

排除标准

  • relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
  • Irregular corneal astigmatism on corneal topography
  • In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

研究组 & 干预措施

Toric intraocular lens (IOL)

Active Comparator

toric intraocular lens for low astigmatism correction

干预措施: toric intraocular lens (Procedure)

Non toric intraocular lens (IOL)

Sham Comparator

non toric intraocular lens

干预措施: non toric intraocular lens (Procedure)

结局指标

主要结局

Subjective refraction to detect remaining astigmatism (in Diopters) between both groups

时间窗: 12 months

次要结局

  • Wavefront analysis of high order aberrations (root mean square, in microns)(12 months)
  • Purkinjemeter measurement of Tilt (in degrees) and Decentration (in degrees) of the intraocular lens(12 months)
  • Biometrical measurement of axial length (in mm), anterior chamber depth (in mm), corneal astigmatism (radii and axial degrees)(12 months)
  • Questionnaire to asses patients subjective satisfaction with visual outcome(12 months)

研究者

发起方
Prim. Prof. Dr. Oliver Findl, MBA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Vienna Institute for Research in Ocular Surgery

研究点 (2)

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