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临床试验/NCT05247099
NCT05247099Unknown不适用

Constructing Children's Eye Data Sharing Platform in Multiple Centers and Multiple Disciplines

Zhongshan Ophthalmic Center, Sun Yat-sen University0 个研究点目标入组 1,000 人开始时间: 2022年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
主要终点
change of the lipid layer of tear film

研究概览

简要总结

Use cohort research to analyze and compare eyes of healthy children and children with systemic diseases. Understand and analyze the incidence, characteristics and influencing factors of children's ocular surface diseases. Establish a multi-center children's eye data sharing platform to provide basic data support for the diagnosis and treatment of children's ocular surface diseases.

详细描述

Use cohort research to analyze and compare eyes of healthy children and children with systemic diseases. Understand and analyze the incidence, characteristics and influencing factors of children's ocular surface diseases. Establish a multi-center children's eye data sharing platform to provide basic data support for the diagnosis and treatment of children's ocular surface diseases.

All participants will be recruited from Zhongshan Ophthalmic Center, Sun Yat-sen University and Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University. Only children with written informed consent from their parents can participate in this study.

Participants will be excluded for (1) age>18; (2) previous use of orthokeratology lenses or low-concentration atropine; (3) allergy to compound tropicamide eye drop; (4) any history of ocular surgery.

All participants will undergo optometry and biometric measurements by a trained team. The axial length (AL), central corneal thickness (CCT), anterior corneal radii of curvature, anterior chamber depth (ACD), lens thickness (LT), the curvature power of the central flat meridian (K1) and the central steep meridian (K2), the ocular surface and fundus will be measured. All measurements will be taken in room light condition (1000 lux).

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Cooperate with eye examination
  • Sign informed consent

排除标准

  • Cannot cooperate with eye examination
  • The researcher believes that the patient is not suitable to participate in the study.

结局指标

主要结局

change of the lipid layer of tear film

时间窗: baseline, 24th months

change of the lipid layer of tear film in nanometers

change of the non-invasive tear break-up time

时间窗: baseline, 24th months

change of the non-invasive tear break-up time in seconds

次要结局

  • intraocular pressure(baseline, 6th months, 12th months, 18th months, 24th months)
  • Anterior chamber depth(baseline, 6th months, 12th months, 18th months, 24th months)
  • Eye axis length(baseline, 6th months, 12th months, 18th months, 24th months)
  • non-invasive tear break-up time(6th months, 12th months, 18th months)
  • vision(baseline, 6th months, 12th months, 18th months, 24th months)
  • central corneal thickness(baseline, 6th months, 12th months, 18th months, 24th months)
  • Retina thickness(baseline, 6th months, 12th months, 18th months, 24th months)
  • Corneal curvature(baseline, 6th months, 12th months, 18th months, 24th months)
  • Lens thickness(baseline, 6th months, 12th months, 18th months, 24th months)
  • choroid thickness(baseline, 6th months, 12th months, 18th months, 24th months)
  • the lipid layer of the tear film(6th months, 12th months, 18th months)

研究者

申办方类型
Other
责任方
Sponsor

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