RecruitingNCT05705778Updated Jan 31, 2023

Plasma Biomarker in Amblyopia Patients

An observational study in Amblyopia, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational

Study type: Observational
Model: Cohort
Time perspective: Other
Enrollment: 600
Ages: 3 Years to 12 Years
Sex: All

Study 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 studied

Amblyopia

Browse trials for

Amblyopia 182

Keywords

amblyopia
plasma biomarker
prediction
treatment outcome

Who can participate

Ages eligible: 3 Years to 12 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

amblyopia patients

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

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

Observational model: Cohort
Time perspective: Other
Enrollment: 600 participants (estimated)
Patient registry: No

Groups and cohorts

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

Procedurestandard amblyopia treatment
amblyopia treatment following international guidelines and genetic tests.
Also known as: plasma biomarker test

What researchers measure

Primary outcomes

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.
Time frame: 2 years after including into this clinical trial

Study locations

1 of 1 sites recruiting

Zhongshan Ophthalmic Center
Guangzhou, Guangdong 510060, China
- Jinrong Li, PhD · Contact · lijingr3@mail.sysu.edu.cn
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT05705778
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party: Jingrong Li (Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted: Jan 31, 2023
Start date: Nov 1, 2022
Primary completion: Oct 31, 2025 (estimated)
Completion: Oct 31, 2027 (estimated)
Last update: Jan 31, 2023

Study contacts

Jinrong Li, PhD

Contact

lijingr3@mail.sysu.edu.cn

86-020-87330351

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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