AmblyopiaNCT05705778
Plasma Biomarker in Amblyopia Patients
An observational study of Amblyopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia
- What is being tested?
- standard amblyopia treatment
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: amblyopia patients
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
Jinrong Li, PhD, lijingr3@mail.sysu.edu.cn
About this study
Official title: 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.
- Conditions
- Amblyopia
- Being tested
- standard amblyopia treatment
- Keywords
- amblyopia, plasma biomarker, prediction, treatment outcome
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard amblyopia treatmentProcedure or surgery
Also called plasma biomarker test
amblyopia treatment following international guidelines and genetic tests.
| Study group | Role | What they receive |
|---|---|---|
| Strabismic | Not described Receives: Procedure: standard amblyopia treatment | |
| Anisometropic | Not described Receives: Procedure: standard amblyopia treatment | |
| Isoametropic | Not described Receives: Procedure: standard amblyopia treatment | |
| Visual deprivation | Not described Receives: Procedure: standard amblyopia treatment | |
| Mixed group | Not described Receives: Procedure: standard amblyopia treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after including into this clinical trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Nov 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingrong Li, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705778
- Sponsor's protocol ID
- 2022KYPJ102
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Plasma Biomarkers Among Patients With Amblyopia
- ClinicalTrials.gov ID
- NCT05705778
- Acronym / sponsor ID
- 2022KYPJ102
- Conditions
- Amblyopia
- Keywords
- amblyopia, plasma biomarker, prediction, treatment outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- amblyopia patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard amblyopia treatmentAlso: plasma biomarker testamblyopia treatment following international guidelines and genetic tests. | Procedure or surgery | Anisometropic, Isoametropic, Mixed group, Strabismic, Visual deprivation |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Amblyopia
RecruitingPhase 3
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Amblyopia
Recruiting
OCT Eccentric Fixation and Amblyopia in Children
Amblyopia
Not yet recruiting
Non-invasive Induction of Metaplasticity for Amblyopia
Amblyopia, Amblyopia Unilateral
Recruiting
Evaluation of AmblyoFix for the Treatment of Unilateral Amblyopia in Children
Amblyopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amblyopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinrong Li, PhD (86-020-87330351, lijingr3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.