Pediatric Eye Care Investigated Team

Children Clinical Trial

— PECT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05247099
• Other study ID #: 2021KYPJ185
• Status: Not yet recruiting
• Start date: February 2022
• Est. completion date: July 2022

Study information

• Verified date: January 2022
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Yingting Zhu
• Phone: 13580585671
• Email: ytzhu16[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Eye Diseases
• Ocular Surface Disease
• Systemic Disease

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ocular surface disease index	It'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.	baseline, 6th months, 12th months, 18th months, 24th months
Primary	change of the non-invasive tear break-up time	change of the non-invasive tear break-up time in seconds	baseline, 24th months
Primary	change of the lipid layer of tear film	change of the lipid layer of tear film in nanometers	baseline, 24th months
Secondary	vision	spherical equivalent in diopters	baseline, 6th months, 12th months, 18th months, 24th months
Secondary	intraocular pressure	the intraocular pressure in mm Hg	baseline, 6th months, 12th months, 18th months, 24th months
Secondary	Eye axis length	Eye axis length in millimeters	baseline, 6th months, 12th months, 18th months, 24th months
Secondary	Anterior chamber depth	Anterior chamber depth in millimeters	baseline, 6th months, 12th months, 18th months, 24th months
Secondary	central corneal thickness	central corneal thickness in millimeters	baseline, 6th months, 12th months, 18th months, 24th months
Secondary	Lens thickness	Anterior chamber depth in millimeters	baseline, 6th months, 12th months, 18th months, 24th months
Secondary	Retina thickness	retina thickness in millimeters	baseline, 6th months, 12th months, 18th months, 24th months
Secondary	choroid thickness	choroid thickness in millimeters	baseline, 6th months, 12th months, 18th months, 24th months
Secondary	Corneal curvature	Corneal curvature in diopters	baseline, 6th months, 12th months, 18th months, 24th months
Secondary	non-invasive tear break-up time	non-invasive tear break-up time in seconds	6th months, 12th months, 18th months
Secondary	the lipid layer of the tear film	the lipid layer of the tear film in nanometers	6th months, 12th months, 18th months