High Myopia clinical trials

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

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. 2. 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.