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Plasma Biomarker in Amblyopia Patients

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05705778
Collaborator
(none)
600
Enrollment
1
Location
60
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective study aims to observe the predictive effect of peripheral blood plasma biomarker on the outcome of treatment in children with different types of amblyopia. We also investigated the mechanism of neuromodulation in the visual development of amblyopic children.

Condition or Disease Intervention/Treatment Phase
  • Procedure: standard amblyopia treatment

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Prognostic Value of Plasma Biomarkers Among Patients With Amblyopia
Actual Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2025
Anticipated Study Completion Date :
Oct 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Strabismic

Procedure: standard amblyopia treatment
amblyopia treatment following international guidelines and genetic tests.
Other Names:
  • plasma biomarker test

    		•
    Anisometropic

    Procedure: standard amblyopia treatment
    amblyopia treatment following international guidelines and genetic tests.
    Other Names:
  • plasma biomarker test

    		•
    Isoametropic

    Procedure: standard amblyopia treatment
    amblyopia treatment following international guidelines and genetic tests.
    Other Names:
  • plasma biomarker test

    		•
    Visual deprivation

    Procedure: standard amblyopia treatment
    amblyopia treatment following international guidelines and genetic tests.
    Other Names:
  • plasma biomarker test

    		•
    Mixed group

    Procedure: standard amblyopia treatment
    amblyopia treatment following international guidelines and genetic tests.
    Other Names:
  • plasma biomarker test

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma protein predictor screening for visual acuity improvement following amblyopia therapy using Tandem Mass Tags proteomics [2 years after including into this clinical trial]

      Peripheral blood will be collected prior and after treatment. The plasma will be separated and Tandem Mass Tags will be used for proteomics. We will detect the different expression of plasma protein between successfully treated and untreated amblyopia patients to find biomarkers that predict amblyopia treatment success. Amblyopia treatment success is defined as best corrected visual acuity (BCVA) improvement of 3 or more logMAR lines.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Diagnosed with amblyopia

    • 3-12 years of age

    • Able to tolerate amblyopia treatment

    • Agree to be involved in this study and agree to have a follow up visit every 3 months.

    Exclusion Criteria:

    • Have previous treatment history before

    • Have pathological ocular anomalies known to cause reduced visual acuity

    • Have previous psychiatric, visual or neurological disorders

    • Have eccentric fixation and/or abnormal retinal correspondence

    • Have attention disorder and learning disability that cannot comprehend psychophysical test instructions given and/or consent for themselves

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center Guangzhou Guangdong China 510060

    Sponsors and Collaborators

    • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jingrong Li, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05705778
    Other Study ID Numbers:
    • 2022KYPJ102
    First Posted:
    Jan 31, 2023
    Last Update Posted:
    Jan 31, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jingrong Li, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
    amblyopia
    plasma biomarker
    prediction
    treatment outcome
    Additional relevant MeSH terms:
    Amblyopia

    Study Results

    No Results Posted as of Jan 31, 2023