PECT: Pediatric Eye Care Investigated Team

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05247099
Collaborator
Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University ( Foshan Maternity & Child Healthcare Hospital) (Other)
1,000
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Constructing Children's Eye Data Sharing Platform in Multiple Centers and Multiple Disciplines
    Anticipated Study Start Date :
    Feb 1, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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 eyelid diseases: eyelid entropion, eyelid ectropion, ptosis, and palpebral dyskinesia; conjunctival diseases: pterygium and conjunctivitis; history of ocular surface chemical injury; history of eye surgery within 6 months or history of retinal laser photocoagulation; systemic diseases: Sjogren syndrome, Parkinson's disease, rheumatoid arthritis, Grave's disease, systemic lupus erythematosus, and others.

    Outcome Measures

    Primary Outcome Measures

    1. change of the non-invasive tear break-up time [baseline, 24th months]

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

    2. change of the lipid layer of tear film [baseline, 24th months]

      change of the lipid layer of tear film in nanometers

    Secondary Outcome Measures

    1. vision [baseline, 6th months, 12th months, 18th months, 24th months]

      spherical equivalent in diopters

    2. intraocular pressure [baseline, 6th months, 12th months, 18th months, 24th months]

      the intraocular pressure in mm Hg

    3. Eye axis length [baseline, 6th months, 12th months, 18th months, 24th months]

      Eye axis length in millimeters

    4. Anterior chamber depth [baseline, 6th months, 12th months, 18th months, 24th months]

      Anterior chamber depth in millimeters

    5. central corneal thickness [baseline, 6th months, 12th months, 18th months, 24th months]

      central corneal thickness in millimeters

    6. Lens thickness [baseline, 6th months, 12th months, 18th months, 24th months]

      Anterior chamber depth in millimeters

    7. Retina thickness [baseline, 6th months, 12th months, 18th months, 24th months]

      retina thickness in millimeters

    8. choroid thickness [baseline, 6th months, 12th months, 18th months, 24th months]

      choroid thickness in millimeters

    9. Corneal curvature [baseline, 6th months, 12th months, 18th months, 24th months]

      Corneal curvature in diopters

    10. non-invasive tear break-up time [6th months, 12th months, 18th months]

      non-invasive tear break-up time in seconds

    11. the lipid layer of the tear film [6th months, 12th months, 18th months]

      the lipid layer of the tear film in nanometers

    Other Outcome Measures

    1. ocular surface disease index [baseline, 6th months, 12th months, 18th months, 24th months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      1. Ageā‰¤18
      1. Cooperate with eye examination
      1. Sign informed consent
    Exclusion Criteria:
      1. Cannot cooperate with eye examination
      1. The researcher believes that the patient is not suitable to participate in the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05247099
    Other Study ID Numbers:
    • 2021KYPJ185
    First Posted:
    Feb 18, 2022
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2022