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临床试验/NCT05250440
NCT05250440招募中不适用

Noninvasive and Dynamic Monitoring the Biological Parameters of Eyes in Different Age Groups

Zhongnan Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
1
主要终点
Anterior scleral thickness

研究概览

简要总结

Myopia is the most common refractive eye disease worldwide. The number of cases is up to 2 billion. In recent years, the incidence of myopia in China is obviously rising trend. As early as the 2018 national health committee epidemiological data show that teenage myopia rate in China has been the first in the world, and has become the influence in China, especially the youth eye health major public health problem. In recent years, prevention and control measures for myopia have emerged in endlessly, such as increasing outdoor activity time, sufficient sunlight exposure, orthokeratology and local use of low-concentration atropine can partially prevent the occurrence or slow down the progression of myopia. But the effects are limited and cannot completely inhibit the development of myopia.

In recent years, with the in-depth study of myopia, it is found that myopia is not only the change of diopter, but also the pathological changes of the whole eyeball shape and corresponding tissues. The incidence of myopia is closely related to the biological parameters of the eyeball, which has become a hotspot of clinical research in recent years. Current studies believe that eyeball biological parameters such as axial length, scleral thickness, choroid thickness are related to the occurrence of myopia, among which the change of scleral structure and shape, namely scleral remodeling, is considered to be an important factor in all visual stimuli leading to myopia. A large number of studies have also shown that scleral remodeling can lead to changes in the scleral biomechanics, thereby promoting the development of myopia. Multiple studies have shown a negative correlation between myopia and scleral thickness, with the thinning of the lower anterior sclera being the most significant. The lower anterior sclera is considered to be a marker for predicting the development of myopia, but some studies have found no correlation between the two. Such differences in the results may be related to the precision of the measurement instrument, the sample size of the included cases, age, and the grouping of different refractive states. The correlation between various biological parameters of the eyeball, especially the sclera, and myopia is not clear at present. Therefore, more penetrating and clearer instruments, more sample sizes, and more scientific grouping are needed for further research and confirmation.

详细描述

The Department of Ophthalmology, Zhongnan Hospital of Wuhan University, has a variety of the most advanced instruments and equipment in the world, such as the newly listed TOMEY CASIA2, which is non-invasive and non-contact, and can quickly obtain the living body tomography of the anterior part of the eye tissue structure at one time, and can conduct quantitative analysis. The latest generation of Ultra Wide Angle fundus imager (Optoc) that is, under the small pupil to obtain nearly 200 degrees fundus image, Heidelberg confocal fundus diagnostic instrument, IOL MASTER700 biometric instrument, etc. This topic is proposed to use an eye the forefront of the latest generation of instruments and equipment, to emmetropia, mild myopia, moderate myopia and high myopia eyeball all biological parameters measurement, explore various biological parameters and the correlation of myopia, for myopia prevention and control such as nearsightedness in the process of the follow-up biological indicators need to focus on monitoring, provide powerful clinical basis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Resident population in Hubei Province
  • No gender preference
  • Healthy population aged between 12 and 35

排除标准

  • Systemic diseases
  • History of other eye diseases, surgery and/or medications, and eye trauma
  • Anisometropia > 2.00 D
  • Astigmatism > 2.00 D
  • The best corrected visual acuity was less than 0.8

结局指标

主要结局

Anterior scleral thickness

时间窗: 10 am to 12 am, every day

Anterior segment OCT images used to determine anterior scleral thickness obtained by gazing in 4 directions (superior, temporal, inferior, and nasal).

Axial length

时间窗: 10 am to 12 am, every day

Axial length was measured by IOL Master700 partially coherent interferometry.

Choroid thickness

时间窗: 10 am to 12 am, every day

Spectralis HRA+OCT images used to determine choroid thickness obtained by gazing in 4 directions (superior, temporal, inferior, and nasal).

Posterior scleral thickness

时间窗: 10 am to 12 am, every day

Spectralis HRA+OCT images used to determine posterior scleral thickness under fovea.

次要结局

未报告次要终点

研究者

发起方
Zhongnan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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