Refraction ErrorNCT05305274
Age and Refraction in Predicting Myopia Progression in COVID-19
An observational study of Refraction Error and Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
To determine the longitudinal changes of age and refraction in predicting myopia progression with risk under the coronavirus disease 2019 (COVID-19) pandemic in a 3-year follow-up of a Chinese cohort. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Refraction Error, Myopia
- What is being tested?
- screening
- How many people
- 34,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Dec 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study includes 34,400 schoolchildren, with a 36-month follow-up from 2019 to 2021. In addition to RE considerations, the inclusion criteria were: no concurrent eye disease; age 6-15 years. The exclusion criteria were: significant systemic illnesses or ocular conditions that could affect the corneal curvature, including congenital corneal diseases, pterygium, keratoconus, other corneal degeneration or dystrophy conditions, media opacity, uveitis, glaucoma or a history of intraocular surgery, refractive surgery, neurologic or retinal diseases, current corneal refractive therapy (ortho-K), or low-dose atropine therapy for myopia control. The ethics board of the Tianjin Eye Hospital, Tianjin, China, approved this school-based cohort study (No: 2022018).
Who may be able to join
- no concurrent eye disease;
- age 6-15 years.
Who cannot join
- significant systemic illnesses
- ocular conditions that could affect the corneal curvature, including congenital corneal diseases,
- pterygium, keratoconus, other corneal degeneration or dystrophy conditions,
- media opacity, uveitis, glaucoma
- a history of intraocular surgery, refractive surgery,
- neurologic or retinal diseases, current corneal refractive therapy (ortho-K),
- low-dose atropine therapy for myopia control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Age and Refraction in Predicting Myopia Progression With Risk Under COVID-19 in a 3-year Follow-up of a Chinese Cohort
To determine the longitudinal changes of age and refraction in predicting myopia progression with risk under the coronavirus disease 2019 (COVID-19) pandemic in a 3-year follow-up of a Chinese cohort.
Read the detailed description
This was part of the large-scale Tianjin Eye Study, a population-based cohort study that longitudinally investigates the relationship between the age, refraction, and development of childhood RE in Tianjin, China.
- Conditions
- Refraction Error, Myopia
- Being tested
- screening
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screeningOther
This study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed.
| Study group | Role | What they receive |
|---|---|---|
| 2019 screening | 34,400 schoolchildren with a 36-month follow-up from 2019 to 2021. Receives: Other: screening | |
| 2020 screening | 34,400 schoolchildren with a 36-month follow-up from 2019 to 2021. Receives: Other: screening | |
| 2021 screening | 34,400 schoolchildren with a 36-month follow-up from 2019 to 2021. Receives: Other: screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of sphere
changes of sphere
Measured: change from baseline at 36 months
changes of cylinder
changes of cylinder
Measured: change from baseline at 36 months
changes of spherical equivalent
changes of spherical equivalent
Measured: change from baseline at 36 months
changes and distribution of visual acuity
changes and distribution of visual acuity
Measured: change from baseline at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Oct 2019
- Primary completion31 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refraction ErrorStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, director, Study chair, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305274
- Sponsor's protocol ID
- 2022018
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu Y, Zhao F, Ding X, Zhang S, Li Z, Guo Y, Feng Z, Tang X, Li Q, Guo L, Lu C, Yang X, He M. Rates of Myopia Development in Young Chinese Schoolchildren During the Outbreak of COVID-19. JAMA Ophthalmol. 2021 Oct 1;139(10):1115-1121. doi: 10.1001/jamaophthalmol.2021.3563.
PubMed 34529002Ma D, Wei S, Li SM, Yang X, Cao K, Hu J, Fan S, Zhang L, Wang N. Progression of myopia in a natural cohort of Chinese children during COVID-19 pandemic. Graefes Arch Clin Exp Ophthalmol. 2021 Sep;259(9):2813-2820. doi: 10.1007/s00417-021-05305-x. Epub 2021 Jul 21.
PubMed 34287693
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Age and Refraction in Predicting Myopia Progression With Risk Under COVID-19 in a 3-year Follow-up of a Chinese Cohort
- ClinicalTrials.gov ID
- NCT05305274
- Acronym / sponsor ID
- 2022018
- Conditions
- Refraction Error, Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34,400 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 31 Mar 2022 (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.
To determine the longitudinal changes of age and refraction in predicting myopia progression with risk under the coronavirus disease 2019 (COVID-19) pandemic in a 3-year follow-up of a Chinese cohort.
Detailed description
This was part of the large-scale Tianjin Eye Study, a population-based cohort study that longitudinally investigates the relationship between the age, refraction, and development of childhood RE in Tianjin, China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2019 screening | – | Other: screening34,400 schoolchildren with a 36-month follow-up from 2019 to 2021. |
| 2020 screening | – | Other: screening34,400 schoolchildren with a 36-month follow-up from 2019 to 2021. |
| 2021 screening | – | Other: screening34,400 schoolchildren with a 36-month follow-up from 2019 to 2021. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study includes 34,400 schoolchildren, with a 36-month follow-up from 2019 to 2021. In addition to RE considerations, the inclusion criteria were: no concurrent eye disease; age 6-15 years. The exclusion criteria were: significant systemic illnesses or ocular conditions that could affect the corneal curvature, including congenital corneal diseases, pterygium, keratoconus, other corneal degeneration or dystrophy conditions, media opacity, uveitis, glaucoma or a history of intraocular surgery, refractive surgery, neurologic or retinal diseases, current corneal refractive therapy (ortho-K), or low-dose atropine therapy for myopia control. The ethics board of the Tianjin Eye Hospital, Tianjin, China, approved this school-based cohort study (No: 2022018).
Key inclusion criteria (2 listed)
- no concurrent eye disease;
- age 6-15 years.
Key exclusion criteria (7 listed)
- significant systemic illnesses
- ocular conditions that could affect the corneal curvature, including congenital corneal diseases,
- pterygium, keratoconus, other corneal degeneration or dystrophy conditions,
- media opacity, uveitis, glaucoma
- a history of intraocular surgery, refractive surgery,
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 |
|---|---|---|
| screeningThis study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed. | Other | 2019 screening, 2020 screening, 2021 screening |
Primary outcome
changes of sphere
Time frame: change from baseline at 36 months
changes of sphere
changes of cylinder
Time frame: change from baseline at 36 months
changes of cylinder
changes of spherical equivalent
Time frame: change from baseline at 36 months
changes of spherical equivalent
changes and distribution of visual acuity
Time frame: change from baseline at 36 months
changes and distribution of visual acuity
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 31 Mar 2022.
- Background: PubMed 34529002Hu Y, Zhao F, Ding X, Zhang S, Li Z, Guo Y, Feng Z, Tang X, Li Q, Guo L, Lu C, Yang X, He M. Rates of Myopia Development in Young Chinese Schoolchildren During the Outbreak of COVID-19. JAMA Ophthalmol. 2021 Oct 1;139(10):1115-1121. doi: 10.1001/jamaophthalmol.2021.3563.
- Background: PubMed 34287693Ma D, Wei S, Li SM, Yang X, Cao K, Hu J, Fan S, Zhang L, Wang N. Progression of myopia in a natural cohort of Chinese children during COVID-19 pandemic. Graefes Arch Clin Exp Ophthalmol. 2021 Sep;259(9):2813-2820. doi: 10.1007/s00417-021-05305-x. Epub 2021 Jul 21.
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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.
Yan Wang, director study chair
Tianjin Eye Hospital
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 Refraction Error and Myopia, 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 2 inclusion and 7 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 31 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 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?
changes of sphere (time frame: change from baseline at 36 months). The study lists 4 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 NCT05305274, which also lists 2 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 31 Mar 2022.