MyomaNCT05925153
Vision Screening Study for College Students at Nankai University
An observational study of Myoma, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
The prevalence of myopia among high school students in China is as high as 80%-90%. For college students with longer years of education, the majority of myopia and the factors influencing the prevalence of high myopia should be better understood for timely prevention and treatment. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Myoma
- How many people
- 8,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Oct 2022
- 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 16 to 30 years
- All sexes
- Child, Adult
Study population: All 1st-year freshmen at Nankai University with no significant systemic or eye diseases are eligible for vision screening
Who may be able to join
- All 1st year students
Who cannot join
- No eye diseases such as cataracts, glaucoma,keratoconus, etc.
- No psychiatric disorders
- Astigmatism ≤ -6.00D
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of myopia among high school students in China is as high as 80%-90%. For college students with longer years of education, the majority of myopia and the factors influencing the prevalence of high myopia should be better understood for timely prevention and treatment. This study aims to investigate the prevalence of myopia and education-related influencing factors among college students at Nankai University.
- Conditions
- Myoma
- Being tested
- No intervention
- Medical subject headings
- Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| College Students | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of myopia
Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye
Measured: One day measurement
Prevalence of high myopia
High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye
Measured: One day measurement
Secondary outcomes (2)
Blood pressure
Venous blood pressure was measured using a sphygmomanometer, and systolic and diastolic blood pressure results were recorded.
Measured: One day measurement
Pulse
Measure the number of pulses in the quiet state and record the number of beats per minute.
Measured: One day measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Sep 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 MyomaStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 8,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925153
- Sponsor's protocol ID
- KY2023030
- Status last verified
- Sep 2022
- First submitted
- 21 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei S, Sun Y, Li S, Hu J, Yang X, Lin C, Cao K, Du J, Guo J, Li H, Wang N. Refractive Errors in University Students in Central China: The Anyang University Students Eye Study. Invest Ophthalmol Vis Sci. 2018 Sep 4;59(11):4691-4700. doi: 10.1167/iovs.18-24363.
PubMed 30267091Wei S, Sun Y, Li SM, Hu J, Cao K, Du J, An W, Liang X, Guo J, Li H, Wang N. Visual Impairment and Spectacle Use in University Students in Central China: The Anyang University Students Eye Study. Am J Ophthalmol. 2019 Oct;206:168-175. doi: 10.1016/j.ajo.2019.04.026. Epub 2019 May 10.
PubMed 31078530Huang L, Kawasaki H, Liu Y, Wang Z. The prevalence of myopia and the factors associated with it among university students in Nanjing: A cross-sectional study. Medicine (Baltimore). 2019 Mar;98(10):e14777. doi: 10.1097/MD.0000000000014777.
PubMed 30855486
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision Screening Study for College Students at Nankai University
- ClinicalTrials.gov ID
- NCT05925153
- Acronym / sponsor ID
- KY2023030
- Conditions
- Myoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,500 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 29 Jun 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.
The prevalence of myopia among high school students in China is as high as 80%-90%. For college students with longer years of education, the majority of myopia and the factors influencing the prevalence of high myopia should be better understood for timely prevention and treatment. This study aims to investigate the prevalence of myopia and education-related influencing factors among college students at Nankai University.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| College Students | – | Other: No intervention |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All 1st-year freshmen at Nankai University with no significant systemic or eye diseases are eligible for vision screening
Key inclusion criteria (1 listed)
- All 1st year students
Key exclusion criteria (3 listed)
- No eye diseases such as cataracts, glaucoma,keratoconus, etc.
- No psychiatric disorders
- Astigmatism ≤ -6.00D
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 |
|---|---|---|
| No interventionNo intervention | Other | College Students |
Primary outcome
Prevalence of myopia
Time frame: One day measurement
Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye
Prevalence of high myopia
Time frame: One day measurement
High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye
2 secondary outcomes
Blood pressure
Time frame: One day measurement
Pulse
Time frame: One day measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Background: PubMed 30267091Wei S, Sun Y, Li S, Hu J, Yang X, Lin C, Cao K, Du J, Guo J, Li H, Wang N. Refractive Errors in University Students in Central China: The Anyang University Students Eye Study. Invest Ophthalmol Vis Sci. 2018 Sep 4;59(11):4691-4700. doi: 10.1167/iovs.18-24363.
- Background: PubMed 31078530Wei S, Sun Y, Li SM, Hu J, Cao K, Du J, An W, Liang X, Guo J, Li H, Wang N. Visual Impairment and Spectacle Use in University Students in Central China: The Anyang University Students Eye Study. Am J Ophthalmol. 2019 Oct;206:168-175. doi: 10.1016/j.ajo.2019.04.026. Epub 2019 May 10.
- Background: PubMed 30855486Huang L, Kawasaki H, Liu Y, Wang Z. The prevalence of myopia and the factors associated with it among university students in Nanjing: A cross-sectional study. Medicine (Baltimore). 2019 Mar;98(10):e14777. doi: 10.1097/MD.0000000000014777.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myoma, run by Tianjin Eye Hospital 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of myopia (time frame: One day measurement). The study lists 2 primary outcomes in all. 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 NCT05925153, 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 29 Jun 2023.