Plasma Biomarker in Amblyopia Patients

Amblyopia Clinical Trial

Official title:

Prognostic Value of Plasma Biomarkers Among Patients With Amblyopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705778
• Other study ID #: 2022KYPJ102
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: October 31, 2027

Study information

• Verified date: January 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Jinrong Li, PhD
• Phone: 86-020-87330351
• Email: lijingr3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia

Intervention

Procedure:
• standard amblyopia treatment
amblyopia treatment following international guidelines and genetic tests.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma protein predictor screening for visual acuity improvement following amblyopia therapy using Tandem Mass Tags proteomics	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.	2 years after including into this clinical trial