Plasma Biomarker in Amblyopia Patients

January 30, 2023 updated by: Jingrong Li, Zhongshan Ophthalmic Center, Sun Yat-sen University

Prognostic Value of Plasma Biomarkers Among Patients With Amblyopia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

amblyopia patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Strabismic
Procedure: standard amblyopia treatment
amblyopia treatment following international guidelines and genetic tests.
Other Names:
  • plasma biomarker test
Anisometropic
Procedure: standard amblyopia treatment
amblyopia treatment following international guidelines and genetic tests.
Other Names:
  • plasma biomarker test
Isoametropic
Procedure: standard amblyopia treatment
amblyopia treatment following international guidelines and genetic tests.
Other Names:
  • plasma biomarker test
Visual deprivation
Procedure: standard amblyopia treatment
amblyopia treatment following international guidelines and genetic tests.
Other Names:
  • plasma biomarker test
Mixed group
Procedure: standard amblyopia treatment
amblyopia treatment following international guidelines and genetic tests.
Other Names:
  • plasma biomarker test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years after including into this clinical trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2022

Primary Completion (ANTICIPATED)

October 31, 2025

Study Completion (ANTICIPATED)

October 31, 2027

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

January 30, 2023

First Posted (ACTUAL)

January 31, 2023

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022KYPJ102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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