Pediatric Eye Care Investigated Team

NCT05247099 | Unknown

• 1 other identifier: 2021KYPJ185
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eye Diseases; Ocular Surface Disease; Systemic Disease; Children

Outcome Measures

Primary Outcomes (2)

• change of the non-invasive tear break-up time

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

  baseline, 24th months

• change of the lipid layer of tear film

  change of the lipid layer of tear film in nanometers

  baseline, 24th months

Secondary Outcomes (11)

• vision

  baseline, 6th months, 12th months, 18th months, 24th months

• intraocular pressure

  baseline, 6th months, 12th months, 18th months, 24th months

• Eye axis length

  baseline, 6th months, 12th months, 18th months, 24th months

• Anterior chamber depth

  baseline, 6th months, 12th months, 18th months, 24th months

• central corneal thickness

  baseline, 6th months, 12th months, 18th months, 24th months

Other Outcomes (1)

• ocular surface disease index

  baseline, 6th months, 12th months, 18th months, 24th months

Study Arms (2)

children with systemic diseases

Systemic diseases such as Nephritic syndrome, and other systemic diseases that can affect the eyes.

healthy children

The exclusion criteria for the subjects were eye diseases or other systemic diseases that can affect the quality or volume of tears or the secretion of tears. These included 1. eyelid diseases: eyelid entropion, eyelid ectropion, ptosis, and palpebral dyskinesia; 2. conjunctival diseases: pterygium and conjunctivitis; 3. history of ocular surface chemical injury; 4. history of eye surgery within 6 months or history of retinal laser photocoagulation; 5. systemic diseases: Sjogren syndrome, Parkinson's disease, rheumatoid arthritis, Grave's disease, systemic lupus erythematosus, and others.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• \. Age≤18
• \. Cooperate with eye examination
• \. Sign informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead
• Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University ( Foshan Maternity & Child Healthcare Hospital): collaborator

Related Publications (1)

• 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.

  PMID: 36114405 DERIVED

MeSH Terms

Conditions

Eye Diseases

Central Study Contacts

Yingting Zhu

CONTACT

13580585671; ytzhu16@163.com

Rui Xie

CONTACT

17673125119; sherie97@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 18, 2022
• Study Start: February 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-01