Myopia, ProgressiveNCT05007626
Near Horizontal Heterophoria in Chinese Children
An observational study of Myopia, Progressive, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
This study aimed to assess the association of refraction and axial length with near-horizontal heterophoria in a large population-based study of school-aged Chinese children. The study makes a significant contribution to better know the etiology of myopia progression and ocular axial length development. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- axial length and refractive error
- How many people
- 15,081 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2017to 31 Dec 2017
- 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 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 15,081 Chinese children between the ages of 6 and 13 years were enrolled in this study. Subjects with eye diseases or strabismus were excluded, so data validated from 11,013 children were used for analysis.
Who may be able to join
- ages of 6 and 13 years
- Chinese school children
Who cannot join
- Subjects with eye diseases or strabismus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Axial Length and Refraction With Near Horizontal Heterophoria in Chinese Children
This study aimed to assess the association of refraction and axial length with near-horizontal heterophoria in a large population-based study of school-aged Chinese children. The study makes a significant contribution to better know the etiology of myopia progression and ocular axial length development. Further, this study will be of interest to the readership of your journal because its noteworthy finding and which could contribute to guide recommendations for targeted interventions to slow myopia progression.
Read the detailed description
Myopia is becoming a global public health burden which is believed to have a multifactorial etiology. The relationship between heterophoria and refraction remains controversial. We describe the association of refraction and axial length (AL) with heterophoria in a large population-based study of school-aged Chinese children. Eleven thousand thirteen elementary school children grades 1-6, were included in this school-based, cross-sectional study. Near phoria data was quantified by using Maddox rod test and prism at 33 cm. Children in each grade level were sorted into three groups based upon phoria: 1) those with more than six prism diopters (PD) exophoria, 2) those with zero to six PD exophoria, and 3) those with any amount of esophoria. Autorefraction was measured by autorefractor (Topcon KR8900, Japan) and AL was measured by Optical Biometer AL-Scan (Nidek AL-Scan, Japan). A generalized additive model (GAM) was applied with a Gaussian link to explore the association between the refractive error or axial length and heterophoria. An additional age-adjusted model was also employed for analysis.
- Conditions
- Myopia, Progressive
- Being tested
- axial length and refractive error
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axial length and refractive errorOther
Comparing the correlation between heterophoria and refraction, even after age adjustment.
| Study group | Role | What they receive |
|---|---|---|
| zero to six Exo | Not described Receives: Other: axial length and refractive error |
What is being measured
The primary outcome is the main question the study is designed to answer.
refractive error
Measured: change from baseline with EDTRS chart at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start29 Jan 2017
- Primary completion30 Dec 2017
- Study completion31 Dec 2017
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 Myopia, ProgressiveStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 15,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Wang, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007626
- Sponsor's protocol ID
- 2021020
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grzybowski A, Kanclerz P, Tsubota K, Lanca C, Saw SM. A review on the epidemiology of myopia in school children worldwide. BMC Ophthalmol. 2020 Jan 14;20(1):27. doi: 10.1186/s12886-019-1220-0.
PubMed 31937276Holden 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 26875007
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Axial Length and Refraction With Near Horizontal Heterophoria in Chinese Children
- ClinicalTrials.gov ID
- NCT05007626
- Acronym / sponsor ID
- 2021020
- Conditions
- Myopia, Progressive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,081 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 29 Jan 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 16 Aug 2021 (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.
This study aimed to assess the association of refraction and axial length with near-horizontal heterophoria in a large population-based study of school-aged Chinese children. The study makes a significant contribution to better know the etiology of myopia progression and ocular axial length development. Further, this study will be of interest to the readership of your journal because its noteworthy finding and which could contribute to guide recommendations for targeted interventions to slow myopia progression.
Detailed description
Myopia is becoming a global public health burden which is believed to have a multifactorial etiology. The relationship between heterophoria and refraction remains controversial. We describe the association of refraction and axial length (AL) with heterophoria in a large population-based study of school-aged Chinese children. Eleven thousand thirteen elementary school children grades 1-6, were included in this school-based, cross-sectional study. Near phoria data was quantified by using Maddox rod test and prism at 33 cm. Children in each grade level were sorted into three groups based upon phoria: 1) those with more than six prism diopters (PD) exophoria, 2) those with zero to six PD exophoria, and 3) those with any amount of esophoria. Autorefraction was measured by autorefractor (Topcon KR8900, Japan) and AL was measured by Optical Biometer AL-Scan (Nidek AL-Scan, Japan). A generalized additive model (GAM) was applied with a Gaussian link to explore the association between the refractive error or axial length and heterophoria. An additional age-adjusted model was also employed for analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zero to six Exo | – | Other: axial length and refractive error |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 15,081 Chinese children between the ages of 6 and 13 years were enrolled in this study. Subjects with eye diseases or strabismus were excluded, so data validated from 11,013 children were used for analysis.
Key inclusion criteria (2 listed)
- ages of 6 and 13 years
- Chinese school children
Key exclusion criteria (1 listed)
- Subjects with eye diseases or strabismus
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 |
|---|---|---|
| axial length and refractive errorComparing the correlation between heterophoria and refraction, even after age adjustment. | Other | zero to six Exo |
Primary outcome
refractive error
Time frame: change from baseline with EDTRS chart at 6 months
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 16 Aug 2021.
- Background: PubMed 31937276Grzybowski A, Kanclerz P, Tsubota K, Lanca C, Saw SM. A review on the epidemiology of myopia in school children worldwide. BMC Ophthalmol. 2020 Jan 14;20(1):27. doi: 10.1186/s12886-019-1220-0.
- 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.
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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 Myopia, Progressive, 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 1 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 16 Aug 2021. 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?
refractive error (time frame: change from baseline with EDTRS chart at 6 months). 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 NCT05007626, 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 16 Aug 2021.