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临床试验/NCT03774992
NCT03774992已完成不适用

Clinical Study Of Nearsightedness, TReatment With Orthokeratology Lenses 2

Vejle Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Axial length

研究概览

简要总结

Myopia is a common disease of the eye with increasing prevalence all over the world including Denmark where the prevalence has increased from 12,8% in 2004 among young adults (mean age 19,3 years) till 17,9% in 2017 among school children (mean age 15,4 years). High myopia is associated with an increasing risk of sight threatening complications such as retinal detachment, glaucoma, macular choroidal degeneration, and myopic choroidal neovascularization. In myopia the eye is elongated compared to an emmetropic eye. If the elongation of the eye can be controlled the progression of myopia can be controlled. Asian studies have shown reduction in axial length growth by 36-46% in children using orthokeratology contact lenses (OKL). OKL are custom fit, form stable lenses. During sleep the cornea is reshaped creating an emmetropic vision during the day, so no glasses or contact lenses are needed.

In the CONTROL-study 60 Danish children aged six to 13 years were randomized 1:1 to either OKL (intervention group) or single vision spectacles (SVS) (control group) and followed for 18 months to compare changes in axial length (AL). In CONTROL2 the intervention group will be followed for another 18 month and the control group will be crossed over to OKL treatment.

The aims of CONTROL2 is to:

  1. Investigate changes in axial length after 3 years of OKL wear (DreamliteR, Procornea, Nederlands).
  2. Investigate changes in progression rate 18 month before and after OKL wear.
  3. Investigate correlations between changes in choroidal thickness and changes in AL.
  4. Investigate the safety of OKL treatment (Efron score).
  5. Investigate changes in quality of life before and after OKL treatment using Pediatric Refractive Error Profile 2 (PREP2).
  6. Investigate correlations between AC/A-ratio, peripheral refraction and higher order aberrations on myopia progression.

详细描述

Myopia is a common disease of the eye with increasing prevalence in the Western World as well as in South East Asia where 60-90% of the children are affected. A Danish study found that early debut of myopia is associated with a higher degree of myopia later on in life. Myopia may be corrected with spectacles, contact lenses or surgically, but despite this socio-economic burden, high myopia is associated with an increasing risk of sight threatening complications such as retinal detachment, glaucoma, macular choroidal degeneration and myopic choroidal neovascularization.

Myopia is a complex disease with a multi-factorial etiology. Twin studies and family studies have shown a high heritability for development of myopia, and more than 40 genetic loci have been identified. Outdoor activity seems to reduce the myopia progression. The shape of the eye may be of importance; axial growth makes the eye ellipsoidal which increase the peripheral defocus on the retina. Peripheral defocus has been suggested to induce further axial growth of the eyeball.

Accommodation is a significant covariant of near work and reading. A cross section study has shown a reduced precision in accommodation (A) on a near object combined with increased convergence (C) in myopic eyes. This increased AC/A ratio (dynamic) may be a predictor for myopia progression.

Interventions for reducing myopia progression have been many. The effects of progressive additional lenses, multifocal lenses and bifocal lenses have been limited. Anticholinergic eyedrops (Atropin 0.01%) significantly reduce the progression of myopia in Asian children by approximately 50% over a period of two years with limited side effects. Almost similar results have been found in Asian children using orthokeratology contact lenses (OKL) for reducing myopia progression.

OKL are custom fit, form stable lenses used during sleep. The lenses induce a temporary flattening of the cornea, which modify or eliminate refractive errors, leaving no need for glasses or contact lenses during daytime. OKL were introduced in the 1960 ́s, but with limited success due to lens material (PMMA) which was not gas-permeable. Decentration was also a problem making the effect variable and unpredictable. With new gas permeable lens materials and computer assisted topographic measurements of the cornea, fitting of the lenses has been improved significantly, so that nightly wear is now standard treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • subjects enrolled in the CONTROL-study

排除标准

  • 未提供

结局指标

主要结局

Axial length

时间窗: 18 months

Change in axial length (mm)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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