Plasma Biomarker in Amblyopia Patients

Recruiting

• Conditions: Amblyopia
• Interventions: Procedure: standard amblyopia treatment

• Registration Number: NCT05705778
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-12-19
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-30
• Last Update Submitted: 2023-01-30
• Study First Posted: 2023-01-31
• Last Update Posted: 2023-01-31
• Primary Completion: 2025-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Strabismic	standard amblyopia treatment	-
Anisometropic	standard amblyopia treatment	-
Mixed group	standard amblyopia treatment	-
Isoametropic	standard amblyopia treatment	-
Visual deprivation	standard amblyopia treatment	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China