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NCT Number: NCT05705778

Plasma Biomarker in Amblyopia Patients

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.

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Jinrong Li, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard amblyopia treatment

Procedure

amblyopia treatment following international guidelines and genetic tests.

Other names: plasma biomarker test

Primary outcomes

  1. Plasma protein predictor screening for visual acuity improvement following amblyopia therapy using Tandem Mass Tags proteomics

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinrong Li, PhD

CONTACT

[email protected]

86-020-87330351

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

Prognostic Value of Plasma Biomarkers Among Patients With Amblyopia

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jan 31, 2023
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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