MyopiaNCT03589937
Ocular Development and Refractive Error Changes Among Children and Adolescent - A Longitudinal Study
An observational study of Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.
Trial summary
The study aims to observe the ocular development and refractive error changes among school children and adolescents Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Myopia
- How many people
- 7,050 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jul 2018to 20 Jul 2024
- 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 3 to 12 years
- All sexes
- Child
Study population: School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7)
Who may be able to join
- School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7).
- No allergy to tropicamide or topical anesthetics
- written informed consent is obtained from guardian
- Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.
Who cannot join
- No history of eye diseases
- Receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses
- A history of allergy to topic amide or topical anesthetics
- Have severe systemic disease
- Missing ability to give informed consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
Zengcheng
Guangzhou, Guangdong, 510000
Zengcheng
Guangzhou, Guangdong
About this study
Official title: A Longitudinal Study on Ocular Development and Refractive Error Changes Among children-and Adolescent
The study aims to observe the ocular development and refractive error changes among school children and adolescents
Read the detailed description
This study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.
- Conditions
- Myopia
- Keywords
- refractive error, ocular structural parameters
- Medical subject headings
- Myopia, Refractive Errors
What is being measured
The primary outcome is the main question the study is designed to answer.
spherical equivalent change
SE was measured by autorefractometer with cycloplegic once a year at scheduled time Every 12 months, follow up for 3 years
Measured: examine every 12 months, follow up for 3 years
Secondary outcomes (5)
Axial length
Axial length is measured by IOMaster once a year at scheduled time
Measured: examine every 12 months, follow up for 3 years
Anterior chamber depth
Anterior chamber depth is measured by IOMaster once a year at scheduled time
Measured: examine every 12 months, follow up for 3 years
lens thickness
lens thickness is measured by IOMaster once a year at scheduled time
Measured: examine every 12 months, follow up for 3 years
Vitreous length
Vitreous length was measured by IOMaster once a year at scheduled time
Measured: examine every 12 months, follow up for 3 years
Environmental factor
Time of outdoor activities \& short range reading,measured by questionnaire
Measured: examine every 12 months, follow up for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start20 Jul 2018
- Primary completion20 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Prospective
- Enrolment
- 7,050 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhi Liu, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Yizhi LIU, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-san University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589937
- Sponsor's protocol ID
- SYSU-OPH-004
- Status last verified
- Mar 2022
- First submitted
- 20 Jun 2018
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study on Ocular Development and Refractive Error Changes Among children-and Adolescent
- ClinicalTrials.gov ID
- NCT03589937
- Acronym / sponsor ID
- SYSU-OPH-004
- Conditions
- Myopia
- Keywords
- refractive error, ocular structural parameters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,050 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 20 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 18 Jul 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.
The study aims to observe the ocular development and refractive error changes among school children and adolescents
Detailed description
This study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7)
Key inclusion criteria (4 listed)
- School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7).
- No allergy to tropicamide or topical anesthetics
- written informed consent is obtained from guardian
- Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.
Key exclusion criteria (5 listed)
- No history of eye diseases
- Receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses
- A history of allergy to topic amide or topical anesthetics
- Have severe systemic disease
- Missing ability to give informed consent
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
spherical equivalent change
Time frame: examine every 12 months, follow up for 3 years
SE was measured by autorefractometer with cycloplegic once a year at scheduled time Every 12 months, follow up for 3 years
5 secondary outcomes
Axial length
Time frame: examine every 12 months, follow up for 3 years
Anterior chamber depth
Time frame: examine every 12 months, follow up for 3 years
lens thickness
Time frame: examine every 12 months, follow up for 3 years
Vitreous length
Time frame: examine every 12 months, follow up for 3 years
Environmental factor
Time frame: examine every 12 months, follow up for 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
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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.
Yizhi LIU, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-san University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
spherical equivalent change (time frame: examine every 12 months, follow up for 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 29 Mar 2022.