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

NCT03666052 | Enrolling By Invitation DMC

• 1 other identifier: SCALE-HM
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.4-5 years old, equivalent spherical error(SE) ≤ -4.0 diopter(D）;
2. 2.6-8 years old, equivalent spherical error(SE) ≤ -6.0 diopter(D）;
3. 3.9-18 years old, equivalent spherical error(SE) ≤ -8.0 diopter(D）.

Conditions

High Myopia; Pathologic Myopia

Keywords

children and adolescent; high myopia; prospective study

Outcome Measures

Primary Outcomes (16)

• spherical equivalent(SE)

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

  June 31, 2038

• axial length(AL)

  collected by IOL master

  June 31, 2038

• corneal curvature

  collected by IOL master

  June 31, 2038

• lens thickness(LT)

  collected by Pentacam

  June 31, 2038

• anterior chamber depth(ACD)

  collected by Pentacam

  June 31, 2038

• vitreous chamber depth(VCD)

  collected by Pentacam

  June 31, 2038

• visual function of macula

  using a Microperimetry

  June 31, 2038

• SS-OCT

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

  June 31, 2038

• SS-OCTA

  blood flow of retina and choroid

  June 31, 2038

• myopic retinopathy

  using color fundus photography and ultra-wide fundus photography

  June 31, 2038

• concentration of microelement in plasma

  concentration of microelement in plasma

  June 31, 2038

• concentration of growth factor(GF) in plasma

  concentration of growth factor in plasma

  June 31, 2038

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

  concentration of IGF-1 in plasma

  June 31, 2038

• concentration of testosterone in plasma

  concentration of testosterone in plasma

  June 31, 2038

• concentration of estradiol in plasma

  concentration of estradiol in plasma

  June 31, 2038

• whole exome sequency of DNA

  find related mutations of myopia

  June 31， 2019

Secondary Outcomes (9)

• uncorrected visual acuity

  June 31, 2038

• corrected visual acuity

  June 31, 2038

• best corrected visual acuity

  June 31, 2038

• spherical power

  June 31, 2038

• cylindrical power

  June 31, 2038

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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 ≤ -4.0 D; 2. 6-8 years old, equivalent spherical error ≤ -6.0 D; 3. 9-18 years old, equivalent spherical error ≤ -8.0 D. 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (1)

• Deng J, Xu X, Pan CW, Wang J, He M, Zhang B, Yang J, Hou XW, Zhu Z, Borchert G, Chen J, Cheng T, Yu S, Fan Y, Liu K, Zou H, Xu X, He X. Myopic maculopathy among Chinese children with high myopia and its association with choroidal and retinal changes: the SCALE-HM study. Br J Ophthalmol. 2024 May 21;108(5):720-728. doi: 10.1136/bjo-2022-321839.

  PMID: 37290823 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

saliva and blood sample 5-10ml

Study Officials

• Xu Xian

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: September 11, 2018
• Study Start: September 16, 2018
• Primary Completion: September 1, 2019
• Study Completion (Estimated): September 1, 2038
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)