Plasma Biomarker in Amblyopia Patients

NCT05705778 | Recruiting DMC

• 1 other identifier: 2022KYPJ102
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia

Keywords

amblyopia; plasma biomarker; prediction; treatment outcome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Strabismic

Procedure: standard amblyopia treatment

Anisometropic

Procedure: standard amblyopia treatment

Isoametropic

Procedure: standard amblyopia treatment

Visual deprivation

Procedure: standard amblyopia treatment

Mixed group

Procedure: standard amblyopia treatment

Interventions

standard amblyopia treatment PROCEDURE

amblyopia treatment following international guidelines and genetic tests.

Also known as: plasma biomarker test

Anisometropic; Isoametropic; Mixed group; Strabismic; Visual deprivation

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

amblyopia patients

You may qualify if:

• Diagnosed with amblyopia
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jinrong Li, PhD

CONTACT

86-020-87330351; lijingr3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 31, 2023
• Study Start: November 1, 2022
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)