High MyopiaNCT03533647
Development and Pathological Changes of High Myopia Among Children and Adolescents in China
An observational study of High Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The study aims to observe the relationship between the changes of ocular structure parameters and pathological changes among children and adolescents with high myopia. Environmental factors and family history will also be collected to explore their impacts on high myopia progression. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- High Myopia
- What is being tested?
- Observational
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2018to 31 May 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 6 to 18 years old school students in Guangzhou. Age between 9-18 years old with either eye had myopia equal or greater than 6.0D ,age between 6-8 years old with either eye had myopia equal or greater than 3.0D
Who may be able to join
- 9 to 18 years old school students in Guangzhou, with either eye had myopia equal or greater than 6.0D
- Or 6 to 8 years old school students in Guangzhou, with either eye had myopia equal or greater than 3.0D
- Written informed consent for study participation
- Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.
Who cannot join
- None school students in Guangzhou
- Other contraindications
- A history of allergy to tropicamide or topical anesthetics
- Missing ability to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yet-san University
Guangzhou, Guangdong, 510000
Yuting LI, Master, +86-020-87334687, ytdorothy@163.com
Qianyun Chen, bachelor, +86-020-87334687, torunchen@163.com
About this study
Official title: A Longitudinal Study on the Development and Pathological Changes Among Children and Adolescents With High Myopia in China
The study aims to observe the relationship between the changes of ocular structure parameters and pathological changes among children and adolescents with high myopia. Environmental factors and family history will also be collected to explore their impacts on high myopia progression.
Read the detailed description
This study aims to observe children and adolescents with high myopia for 3 years, and to collect data of ocular pathological changes, family history and environmental factors so as to understand the natural course and internal laws of the development of high myopia.
- Conditions
- High Myopia
- Being tested
- Observational
- Keywords
- high myopia, ocular biometric parameters, adolescent, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
none (observational study)
| Study group | Role | What they receive |
|---|---|---|
| entire cohort (observational) | none (observational study) Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.
examine the ocular pathological changes
Measured: examine every 12 months, follow up 3 years
Secondary outcomes (1)
To explore the impact of environmental factors and genetic factors on the progression among children and adolescents with high myopia
axial length, refractive error changes, environmental factors, family history, exercise time, eye care habits, form of exercise
Measured: examine every 12 months, follow up 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start14 May 2018
- Primary completion13 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for High 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
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, MD,PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533647
- Sponsor's protocol ID
- SYSU-OPH-003
- Status last verified
- Jun 2018
- First submitted
- 10 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
PubMed 26875007Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singap. 2004 Jan;33(1):27-33.
PubMed 15008558Sun J, Zhou J, Zhao P, Lian J, Zhu H, Zhou Y, Sun Y, Wang Y, Zhao L, Wei Y, Wang L, Cun B, Ge S, Fan X. High prevalence of myopia and high myopia in 5060 Chinese university students in Shanghai. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7504-9. doi: 10.1167/iovs.11-8343.
PubMed 23060137
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study on the Development and Pathological Changes Among Children and Adolescents With High Myopia in China
- ClinicalTrials.gov ID
- NCT03533647
- Acronym / sponsor ID
- SYSU-OPH-003
- Conditions
- High Myopia
- Keywords
- high myopia, ocular biometric parameters, adolescent, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 13 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 23 May 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 relationship between the changes of ocular structure parameters and pathological changes among children and adolescents with high myopia. Environmental factors and family history will also be collected to explore their impacts on high myopia progression.
Detailed description
This study aims to observe children and adolescents with high myopia for 3 years, and to collect data of ocular pathological changes, family history and environmental factors so as to understand the natural course and internal laws of the development of high myopia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| entire cohort (observational) | – | Other: Observationalnone (observational study) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 6 to 18 years old school students in Guangzhou. Age between 9-18 years old with either eye had myopia equal or greater than 6.0D ,age between 6-8 years old with either eye had myopia equal or greater than 3.0D
Key inclusion criteria (4 listed)
- 9 to 18 years old school students in Guangzhou, with either eye had myopia equal or greater than 6.0D
- Or 6 to 8 years old school students in Guangzhou, with either eye had myopia equal or greater than 3.0D
- Written informed consent for study participation
- Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.
Key exclusion criteria (4 listed)
- None school students in Guangzhou
- Other contraindications
- A history of allergy to tropicamide or topical anesthetics
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationalnone (observational study) | Other | entire cohort (observational) |
Primary outcome
To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.
Time frame: examine every 12 months, follow up 3 years
examine the ocular pathological changes
1 secondary outcome
To explore the impact of environmental factors and genetic factors on the progression among children and adolescents with high myopia
Time frame: examine every 12 months, follow up 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Background: PubMed 26875007Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.
- Background: PubMed 15008558Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singap. 2004 Jan;33(1):27-33.
- Background: PubMed 23060137Sun J, Zhou J, Zhao P, Lian J, Zhu H, Zhou Y, Sun Y, Wang Y, Zhao L, Wei Y, Wang L, Cun B, Ge S, Fan X. High prevalence of myopia and high myopia in 5060 Chinese university students in Shanghai. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7504-9. doi: 10.1167/iovs.11-8343.
- Individual participant dataSharing planned: Undecided
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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, 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 High Myopia, 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 4 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 20 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuting LI, master (+86-020-87334687, ytdorothy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia. (time frame: examine every 12 months, follow up 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533647, which also lists 3 linked publications.
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 20 Jun 2018.