Clinical trial NCT05247099: Pediatric Eye Care Investigated Team
Official title: Constructing Children's Eye Data Sharing Platform in Multiple Centers and Multiple Disciplines
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eye Diseases
Ocular Surface Disease
Systemic Disease
Children
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University ( Foshan Maternity & Child Healthcare Hospital)
First posted: 2022-02-18
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Choose suitable patients from the ophthalmology hospital outpatient clinic or the ophthalmology and pediatric outpatient clinics of the Maternal and Child Health Hospital.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: change of the non-invasive tear break-up time
timeFrame: baseline, 24th months
measure: change of the lipid layer of tear film
timeFrame: baseline, 24th months
Secondary outcomes:
measure: vision
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
measure: intraocular pressure
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
measure: Eye axis length
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
measure: Anterior chamber depth
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
measure: central corneal thickness
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
measure: Lens thickness
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
measure: Retina thickness
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
measure: choroid thickness
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
measure: Corneal curvature
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
measure: non-invasive tear break-up time
timeFrame: 6th months, 12th months, 18th months
measure: the lipid layer of the tear film
timeFrame: 6th months, 12th months, 18th months
Other outcomes:
measure: ocular surface disease index
timeFrame: baseline, 6th months, 12th months, 18th months, 24th months
Locations:
Study officials:
References:
citation: Wang Z, Xie R, Luo R, Yao J, Jin L, Zhou Z, Chen K, Zhuo X, Zhu Y, Zhuo Y. Comparisons of Using Cycloplegic Biometry Versus Non-cycloplegic Biometry in the Calculation of the Cycloplegic Refractive Lens Powers. Ophthalmol Ther. 2022 Dec;11(6):2101-2115. doi: 10.1007/s40123-022-00569-w. Epub 2022 Sep 16.