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临床试验/NCT03666052
NCT03666052Enrolling By Invitation不适用

Shanghai Child and Adolescent Large-scale Eye Study -High Myopia Registration

Shanghai Eye Disease Prevention and Treatment Center1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
2,000
试验地点
1
主要终点
spherical equivalent(SE)

研究概览

简要总结

1.1 Research objectives A.To observe the fundus changes in the posterior pole (morphology, thickness, asymmetry, blood flow density, etc) with the myopia progression.

B.To observe morphological changes in choroid and peripheral region of retina with myopia progression.

C. To observe changes of visual function (contrast sensitivity, Microperimetry, etc) with myopia progression.

D. To detect the susceptibility genes related to high myopia and myopic fundus changes; to test the levels of Vitamin D, riboflavin, transforming growth factor(TGF), insulin-like growth factor(IGF), fibroblast growth factor(FGF), etc.

E. To observe the changes of living quality, psychology, behavior and social activities of high myopic children.

1.2 Research design Prospective cohort study. After completing the baseline survey, the planned follow-up frequency is once a year.

1.3 Research cycle 2018.06~2038.06 (at least).

1.4 Expected results A. Registration completed a study of high myopia research for children and adolescents covering around 3,000 people; B. Establish a database information management system and workflow SOP(standard operating procedure)file for the study of high myopia registration in children and adolescents; C. Further clarify the changes in the retinal, choroidal and scleral tissue structures, blood flow density, etc. in the macular area and the optic disc; D. Revealing the changes of the retina, choroid and other tissues in the peripheral area with the progression of myopia; E. To clarify the relationship between changes in the fundus structure and changes in visual function in the posterior pole; F. Further clarify the etiology and pathogenesis of high myopia, pathological myopia and myopic fundus lesions, and identify the relationship between high myopia and pathological myopia; G. From the perspectives of society, behavior and psychology, the effects of high myopia and pathological myopia on children and adolescents will be fully demonstrated.

  1. Research object 2.1 General characteristics of the research object

Based on the refraction development archive system that has been constructed in Shanghai, the list of children and adolescents with high myopia was selected from the database of children's refractive development archives information in Shanghai. Children of different ages with high myopia must meet the following conditions:

  1. 4-5 years old, equivalent spherical error(SE) ≤ -4.0 diopter(D);
  2. 6-8 years old, equivalent spherical error(SE) ≤ -6.0 diopter(D);
  3. 9-18 years old, equivalent spherical error(SE) ≤ -8.0 diopter(D).

2.2 Sample size A total of 1.25 million children and adolescents are currently registered, 4,006 (0.32%) of which meet the entry requirements. Among the 4~5 year olds, there are 815 people with SE≤-4D; 842 people with SE≤-6 D among the 6~8 year olds; 2349 people with SE≤-8D among the people aged 9 and over . Taking into account the 50% non-response and the proportion of the exclusion, the initial registration number is about 2,000.

2.3 Source of study object Children and adolescents who meet the inclusion criteria in the Shanghai Children's Refractive Development Archives Information Database System.

详细描述

  1. introduction 1.1 Overview of myopia and high myopia Myopia is the most common eye disease in the world . Among them, the incidence and prevalence of myopia are highest in developed countries and regions in East and Southeast Asia. It is predicted that by 2050, global myopia patients would reach 5 billion, 1 billion of which were high myopia. In developed countries and regions in East and Southeast Asia, the prevalence of myopia in high school graduates is as high as 80% to 90%. A study in Taiwan showed that more than 80% of adolescents suffered from myopia when they graduated from high school, 10% of whom were high myopia. Another study which focused on university students in Shanghai showed that 95.5% of college students suffered from myopia, and 19.5% of them were high myopia. In stark contrast, the prevalence of myopia in the same age in western developed countries is between 20% and 40%. In less developed countries and regions of the world, the incidence of myopia in young people is about 5% to 10% due to the low level of education.

At present, the etiology and pathogenesis of myopia and high myopia are still unclear. Environmental and genetic factors are involved in the development of myopia and high myopia. Among them, the level of education and outdoor activity time are closely related to the development of myopia and high myopia. At present, most studies believe that the higher the education level, the higher the incidence of myopia and the deeper the degree of myopia. In addition, most studies suggest that outdoor activities was a protective factor for myopia, and increasing outdoor activity time could reduce the incidence of myopia. Also, some studies have shown that the age of onset of myopia was closely related to high myopia. Furthermore, genes may also be closely related to the occurrence of myopia and high myopia. At least 19 myopic loci have been identified through family studies and twin studies till now. With the completion of the Human Genome Project, genome-wide association analysis technology is becoming more and more mature, and more and more related genes and mutation sites have been elucidated, but the pathogenic genes of myopia are still not completely clear. In addition, the genes related to pathological myopia and fundus lesions are currently unclear. In recent studies, high myopia and pathological myopia are not strictly differentiated (pathological myopia is defined by diopter or axial length alone). Therefore, genes related to pathological myopia need further research, in order to judge whether high myopia and pathological myopia are two different diseases at genetic level or different states controlled by the same genes.

1.2 Relationship between high myopia and pathological myopia The fundus of patients with high myopia is often accompanied by a series of pathological changes, such as posterior scleral staphyloma, retinal choroidal atrophy, lacquer crack, choroidal neovascularization(CNV), macular hemorrhage, Fuchs plaque, retinal palpebral fissure, retinal tear, retinal detachment. These pathological changes are important causes of decreased vision and even blindness. Some studies have shown that macular degeneration caused by myopia has become a major cause of blindness and low vision. In Jing'an District of Shanghai, high myopia with macular degeneration has leapt to the first place in adult blindness. A study in Beijing showed that pathological myopia has become the leading cause of blindness and visual impairment in the 40-49 age group.

Although high myopia is closely related to pathological myopia, and most patients with pathological myopia are highly myopic, high myopia is not equivalent to pathological myopia. The change of diopter and axial length do not fully reflect the characteristics of pathological myopia. Some patients with high myopia have no definite fundus lesions, and some non-high myopia patients may also have posterior scleral staphyloma, retinochoroid atrophy and other complications. At present, Ohno-Matsui K et al define pathological myopia as: myopic macular degeneration ≥ 2 (diffuse retinochoroid atrophy), or additional lesions (lacquer cracks, choroidal neovascularization, Fuchs plaque), or posterior scleral staphyloma. In this definition of pathological myopia, we focus on fundus lesions caused by myopia, and do not emphasize diopter and axial length.

At present, there are still many unknowns about the relationship between high myopia and pathological myopia. The process of developing simple high myopia in children and adolescents as pathological myopia is still unclear. Does high myopia eventually evolve into pathological myopia? Are pathological myopia and high myopia different stages of the same disease or two different diseases? Which fundus changes can predict the occurrence of pathological myopia? These problems need further exploration.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents between the ages of 4 and 18 years old, SE ≤ -4 D under 5 years old, SE ≤ -6 D at 6-8 years old, SE ≤ -8 D over 9 years old;
  • No eye disease, good general condition, can cooperate with the examiner;
  • Obtaining the consent of the child and his/her guardian;
  • Long-term residence in this city, there is no plan to move out of this city in the short term.

排除标准

  • Amblyopia (best corrected visual acuity (BCVA) less than 0.8 for children over 6 years old, BCVA less than 0.63 for children 6 years old and younger) and strabismus;
  • Secondary myopia, genetic disease or connective tissue-related myopia;
  • Moderate or severe ptosis;
  • Congenital cataract, glaucoma;
  • Other fundus diseases other than myopic related fundus lesions;
  • Intraocular or refractive surgery history;
  • The refractive medium is turbid, and it is impossible to take a clear fundus image;
  • Unable to cooperate with fundus image shooting and other examination;
  • Do not receive cycloplegia or have contraindications;
  • Poor overall condition, unable to follow up for a long time;
  • The child or the guardian refuses to participate in the research;
  • Other cases in which the researcher judges that it is not suitable for participation in the study.

结局指标

主要结局

spherical equivalent(SE)

时间窗: June 31, 2038

SE=spherical power+1/2\*cylindrical power

axial length(AL)

时间窗: June 31, 2038

collected by IOL master

corneal curvature

时间窗: June 31, 2038

collected by IOL master

concentration of IGF-1 in plasma(IGF-1)

时间窗: June 31, 2038

concentration of IGF-1 in plasma

concentration of testosterone in plasma

时间窗: June 31, 2038

concentration of testosterone in plasma

lens thickness(LT)

时间窗: June 31, 2038

collected by Pentacam

anterior chamber depth(ACD)

时间窗: June 31, 2038

collected by Pentacam

visual function of macula

时间窗: June 31, 2038

using a Microperimetry

myopic retinopathy

时间窗: June 31, 2038

using color fundus photography and ultra-wide fundus photography

concentration of microelement in plasma

时间窗: June 31, 2038

concentration of microelement in plasma

vitreous chamber depth(VCD)

时间窗: June 31, 2038

collected by Pentacam

SS-OCT

时间窗: June 31, 2038

morphology of fundus( en-face and B-scan images)

SS-OCTA

时间窗: June 31, 2038

blood flow of retina and choroid

concentration of growth factor(GF) in plasma

时间窗: June 31, 2038

concentration of growth factor in plasma

concentration of estradiol in plasma

时间窗: June 31, 2038

concentration of estradiol in plasma

whole exome sequency of DNA

时间窗: June 31, 2019

find related mutations of myopia

次要结局

  • best corrected visual acuity(June 31, 2038)
  • corrected visual acuity(June 31, 2038)
  • spherical power(June 31, 2038)
  • weight(June 31, 2038)
  • uncorrected visual acuity(June 31, 2038)
  • cylindrical power(June 31, 2038)
  • intraocular pressure(IOP)(June 31, 2038)
  • height(June 31, 2038)
  • BMI(June 31, 2038)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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