MyopiaNCT03244670
The Incidence and Progression of Myopia: Cohort Study
An observational study of Myopia, run by Sun Yat-sen University at 1 site in China.
Trial summary
A cohort study on incidence and progression of myopia in a group of medical students Read more about this study
- Who is it for?
- Ages 17 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Observation study only, no specific intervention
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2017to 19 Sep 2019
- 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 17 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: First-year medical college student from Zhongshan University
Who may be able to join
- Volunteer subject, , willing to follow the protocol and able to read, comprehend and sign the informed consent form,
- Age between 17 and 23 years
Who cannot join
- Vulnerability of the subject,
- Participation in another study which might have an influence on vision or interfere with study assessments,
- Aphakic or pseudophakic (intraocular lens)
- Participants who are wearing ortho-K lenses, or undergone any kind of myopia control treatments or undergone refractive surgery.
- Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with study assessments (e.g. AMD, glaucoma…),
- Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…),
- Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g. uncontrolled diabetes, uncontrolled high blood pressure…),
- Any medical treatment or medication which might have an influence on vision or interfere with study assessments (e.g. antidepressants, drugs with atropinic effects…),
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cohort Study on Incidence and Progression of Myopia in a Group of Medical Students
A cohort study on incidence and progression of myopia in a group of medical students
Read the detailed description
A prospective cohort study to investigate the refractive error development, progression and their risk factors in young adult population comprises a group of medical students in China for two years
- Conditions
- Myopia
- Being tested
- Observation study only, no specific intervention
- Keywords
- Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation study only, no specific interventionOther
Observation study only, no specific intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
refraction
The participants will be measured for their refractive error by optometrist, and observe the rate of progression of myopia
Measured: Change from baseline for two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start15 Aug 2017
- Primary completion19 Jul 2019
- Study completion19 Sep 2019
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 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Essilor International
- Responsible party
- Principal investigator, Xiang Chen, Sun Yat-sen University
- Investigators
- Chen xiang, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244670
- Sponsor's protocol ID
- TEX2017
- Status last verified
- Sep 2019
- First submitted
- 7 Aug 2017
- Last updated
- 20 Sep 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 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on Incidence and Progression of Myopia in a Group of Medical Students
- ClinicalTrials.gov ID
- NCT03244670
- Acronym / sponsor ID
- TEX2017
- Conditions
- Myopia
- Keywords
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Essilor International
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 9 Aug 2017 (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.
A cohort study on incidence and progression of myopia in a group of medical students
Detailed description
A prospective cohort study to investigate the refractive error development, progression and their risk factors in young adult population comprises a group of medical students in China for two years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- First-year medical college student from Zhongshan University
Key inclusion criteria (2 listed)
- Volunteer subject, , willing to follow the protocol and able to read, comprehend and sign the informed consent form,
- Age between 17 and 23 years
Key exclusion criteria (8 listed)
- Vulnerability of the subject,
- Participation in another study which might have an influence on vision or interfere with study assessments,
- Aphakic or pseudophakic (intraocular lens)
- Participants who are wearing ortho-K lenses, or undergone any kind of myopia control treatments or undergone refractive surgery.
- Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with study assessments (e.g. AMD, glaucoma…),
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 |
|---|---|---|
| Observation study only, no specific interventionObservation study only, no specific intervention | Other | – |
Primary outcome
refraction
Time frame: Change from baseline for two years
The participants will be measured for their refractive error by optometrist, and observe the rate of progression of myopia
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 20 Sep 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.
Chen xiang principal investigator
Associate Professor
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 Myopia, 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 8 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 20 Sep 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 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?
refraction (time frame: Change from baseline for two 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 20 Sep 2019.