Child DevelopmentNCT03409094
Dongguan Eye Study of Schoolchildren and Adolescents（DESSA）
An observational study of Child Development, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a study to report the change of ocular biometry of schoolchildren and adolescents as well as its association with birth parameters in China. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Schoolchildren and adolescents ranging from 7 to 18 years old in Dongguan.
Who may be able to join
- Schoolchildren and adolescents aged 7 to18 years in Dongguan
- Parents are willing to sign the informed written consent.
Who cannot join
- Those without informed written consent or unable to obey the study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on Ocular Biometry Measurement of Schoolchildren and Adolescents in China
This is a study to report the change of ocular biometry of schoolchildren and adolescents as well as its association with birth parameters in China.
- Conditions
- Child Development
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of ocular fundus parameter in schoolchildren and adolescents
Record the change of retinal thickness during the follow-up periods.
Measured: 3 years
Secondary outcomes (2)
Changes of ocular biometry measurement in schoolchildren and adolescents
Record the change of choroidal thickness during the follow-up periods.
Measured: 3 years
Changes of ocular anterior segment in schoolchildren and adolescents
Record the change of corneal thickness during the follow-up periods.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Why it stopped: equipments and staff are unavailable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiulan Zhang, Sun Yat-sen University
- Investigators
- Xiulan Zhang, MD,PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409094
- Sponsor's protocol ID
- 2017KYPJ119
- Status last verified
- Apr 2019
- First submitted
- 17 Jan 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Ocular Biometry Measurement of Schoolchildren and Adolescents in China
- ClinicalTrials.gov ID
- NCT03409094
- Acronym / sponsor ID
- 2017KYPJ119
- Conditions
- Child Development
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: equipments and staff are unavailable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 24 Jan 2018 (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 is a study to report the change of ocular biometry of schoolchildren and adolescents as well as its association with birth parameters in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Schoolchildren and adolescents ranging from 7 to 18 years old in Dongguan.
Key inclusion criteria (2 listed)
- Schoolchildren and adolescents aged 7 to18 years in Dongguan
- Parents are willing to sign the informed written consent.
Key exclusion criteria (1 listed)
- Those without informed written consent or unable to obey the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of ocular fundus parameter in schoolchildren and adolescents
Time frame: 3 years
Record the change of retinal thickness during the follow-up periods.
2 secondary outcomes
Changes of ocular biometry measurement in schoolchildren and adolescents
Time frame: 3 years
Changes of ocular anterior segment in schoolchildren and adolescents
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xiulan Zhang, MD,PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 Child Development, run by 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 16 Apr 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of ocular fundus parameter in schoolchildren and adolescents (time frame: 3 years). 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 16 Apr 2019.