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Pediatric Eye Care Investigated Team

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05247099
Acronym
PECT
Enrollment
1000
Registered
2022-02-18
Start date
2022-02-28
Completion date
2022-07-31
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Eye Diseases, Ocular Surface Disease, Systemic Disease

Brief summary

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.

Detailed description

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).

Interventions

None listed

Sponsors

Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University ( Foshan Maternity & Child Healthcare Hospital)
CollaboratorUNKNOWN
Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* 1\. Age≤18 * 2\. Cooperate with eye examination * 3\. Sign informed consent

Exclusion criteria

* 1\. Cannot cooperate with eye examination * 2\. The researcher believes that the patient is not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
change of the lipid layer of tear filmbaseline, 24th monthschange of the lipid layer of tear film in nanometers
change of the non-invasive tear break-up timebaseline, 24th monthschange of the non-invasive tear break-up time in seconds

Secondary

MeasureTime frameDescription
Eye axis lengthbaseline, 6th months, 12th months, 18th months, 24th monthsEye axis length in millimeters
visionbaseline, 6th months, 12th months, 18th months, 24th monthsspherical equivalent in diopters
Anterior chamber depthbaseline, 6th months, 12th months, 18th months, 24th monthsAnterior chamber depth in millimeters
central corneal thicknessbaseline, 6th months, 12th months, 18th months, 24th monthscentral corneal thickness in millimeters
Lens thicknessbaseline, 6th months, 12th months, 18th months, 24th monthsAnterior chamber depth in millimeters
choroid thicknessbaseline, 6th months, 12th months, 18th months, 24th monthschoroid thickness in millimeters
Corneal curvaturebaseline, 6th months, 12th months, 18th months, 24th monthsCorneal curvature in diopters
non-invasive tear break-up time6th months, 12th months, 18th monthsnon-invasive tear break-up time in seconds
the lipid layer of the tear film6th months, 12th months, 18th monthsthe lipid layer of the tear film in nanometers
Retina thicknessbaseline, 6th months, 12th months, 18th months, 24th monthsretina thickness in millimeters
intraocular pressurebaseline, 6th months, 12th months, 18th months, 24th monthsthe intraocular pressure in mm Hg

Other

MeasureTime frameDescription
ocular surface disease indexbaseline, 6th months, 12th months, 18th months, 24th monthsIt's a scale for the diagnostic score of dry eye. The total score ranges from 0 to 100, with higher scores indicating more severe symptoms.

Contacts

Primary ContactYingting Zhu
ytzhu16@163.com13580585671
Backup ContactRui Xie
sherie97@163.com17673125119

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026