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

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

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

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

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.

Interested in participating?

Recruiting

Interested in participating?

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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.

Published trials that share one or more normalized conditions with this study.

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