High MyopiaNCT06204211
Genetic Research on High Myopic Individuals in Northern China
An observational study of High Myopia, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
HM, which can dramatically cripple the eyesight of those affected, is a rampant ophthalmic disorder around the globe. It is in recent years that substantial studies covering the relationship between distinct variations and HM susceptibility sprang expeditiously. Read more about this study
- Who is it for?
- Ages 1 year to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- High Myopia
- What is being tested?
- ophthalmologic examinations
- How many people
- 1,340 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Aug 2023
- 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 1 year to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We enrolled HM participants characterized by AL ≥ 26.00 mm or SE ≤ -6.00 D in at least one eye at the Department of Ophthalmology of the First Affiliated Hospital of Zhengzhou University (Zhengzhou, Henan Province, China) from May 2022 to April 2023 as cases and unrelated normal volunteers with SE ranging from -0.50 D to +0.50 D as controls.
Who may be able to join
- HM participants are characterized by AL ≥ 26.00 mm or SE ≤ -6.00 D in at least one eye.
Who cannot join
- Individuals with other ocular or systemic connective tissue diseases were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
HM, which can dramatically cripple the eyesight of those affected, is a rampant ophthalmic disorder around the globe. It is in recent years that substantial studies covering the relationship between distinct variations and HM susceptibility sprang expeditiously. However, these studies have not yielded sufficiently credible and universally significant conclusions. Consequently, the study is conducted by including HM subjects residing in Northern China to explicitly illustrate this issue.
Read the detailed description
As a serious pattern of myopia, high myopia (HM) generally refers to a condition where the spherical equivalent (SE) refraction exceeds -6.00 diopters (D) or the axial length (AL) is longer than 26.00 mm. Abundant studies have indicated the strong correlation of HM with multiple vision-threatening ophthalmic diseases, including rhegmatogenous retinal detachment, retinoschisis, retinochoroid atrophy and open-angle glaucoma. It is reported that the worldwide prevalence of HM has surpassed over 2.9% in recent years. And a study on subjects living in Minnesota from the 1960s to the 2010s demonstrates that the data has progressively increasing from 2.8% to 8.3%, which is not related with gender or race, although no evident significance has yet been proved in some groups. What's worse, it is speculated that HM patients are expected to account for 9.8% of the global population by 2050, which will gravely hinder the progress of social development. As a result, it is of profound implications to explore the pathogenesis of HM and the prospective therapeutic or remedial strategies.
What has been universally acknowledged is that both environmental and genetic factors matter much in the onset and exacerbation of myopia, with the latter particularly predominating in the etiology of HM. Accordingly, discussing the causation of HM from heredity version is likely to be the most promising research field, which is just the researchers' interest at the present.
- Conditions
- High Myopia
- Being tested
- ophthalmologic examinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmologic examinationsDiagnostic test
All the included personnel underwent routine ophthalmologic examinations on binoculus, including slit lamp microscope observation, intraocular pressure, diopters of refractive error, best corrected visual acuity, AL measurement, fundus photography and optical coherence tomography, adhering to the established and normalized principles.
| Study group | Role | What they receive |
|---|---|---|
| High myopia | HM participants characterized by AL ≥ 26.00 mm or SE ≤ -6.00 D in at least one eye at the Department of Ophthalmology of the First Affiliated Hospital of Zhengzhou University (Zhengzhou, Henan Province, China) from May 2022 to April 2023 are included as cases. Receives: Diagnostic Test: ophthalmologic examinations | |
| Control | Demographic-matched emmetropic volunteers without consanguinity serve as controls. Receives: Diagnostic Test: ophthalmologic examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
diopter
This study performs the subgroup analysis based on SE (≤ -20.00 D, -20.00 ~ -15.00 D, -15.00 ~ -10.00 D, and -10.00 ~ -6.00 D) to clarify the correlation between different genetic SNPs and HM inclination more thoroughly.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 May 2022
- Primary completion30 Apr 2023
- Study completion31 Aug 2023
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 High MyopiaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,340 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liping Du, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Liping Du, Study chair, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204211
- Sponsor's protocol ID
- 2022-KY-0512-002
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev. 2016 May 3;1:2. doi: 10.1186/s41073-016-0007-6. eCollection 2016.
PubMed 29451543Gao W, Zhang M, An G, Yang F, Li L, Jin X, Du L. The association of ARR3 genetic polymorphisms with pathologic myopia in Northern Chinese population. Exp Eye Res. 2025 Dec;261:110691. doi: 10.1016/j.exer.2025.110691. Epub 2025 Oct 9.
PubMed 41076047
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Research on High Myopic Individuals in Northern China
- ClinicalTrials.gov ID
- NCT06204211
- Acronym / sponsor ID
- 2022-KY-0512-002
- Conditions
- High Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,340 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 12 Jan 2024 (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.
HM, which can dramatically cripple the eyesight of those affected, is a rampant ophthalmic disorder around the globe. It is in recent years that substantial studies covering the relationship between distinct variations and HM susceptibility sprang expeditiously. However, these studies have not yielded sufficiently credible and universally significant conclusions. Consequently, the study is conducted by including HM subjects residing in Northern China to explicitly illustrate this issue.
Detailed description
As a serious pattern of myopia, high myopia (HM) generally refers to a condition where the spherical equivalent (SE) refraction exceeds -6.00 diopters (D) or the axial length (AL) is longer than 26.00 mm. Abundant studies have indicated the strong correlation of HM with multiple vision-threatening ophthalmic diseases, including rhegmatogenous retinal detachment, retinoschisis, retinochoroid atrophy and open-angle glaucoma. It is reported that the worldwide prevalence of HM has surpassed over 2.9% in recent years. And a study on subjects living in Minnesota from the 1960s to the 2010s demonstrates that the data has progressively increasing from 2.8% to 8.3%, which is not related with gender or race, although no evident significance has yet been proved in some groups. What's worse, it is speculated that HM patients are expected to account for 9.8% of the global population by 2050, which will gravely hinder the progress of social development. As a result, it is of profound implications to explore the pathogenesis of HM and the prospective therapeutic or remedial strategies.
What has been universally acknowledged is that both environmental and genetic factors matter much in the onset and exacerbation of myopia, with the latter particularly predominating in the etiology of HM. Accordingly, discussing the causation of HM from heredity version is likely to be the most promising research field, which is just the researchers' interest at the present.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High myopia | – | Diagnostic Test: ophthalmologic examinationsHM participants characterized by AL ≥ 26.00 mm or SE ≤ -6.00 D in at least one eye at the Department of Ophthalmology of the First Affiliated Hospital of Zhengzhou University (Zhengzhou, Henan Province, China) from May 2022 to April 2023 are included as cases. |
| Control | – | Diagnostic Test: ophthalmologic examinationsDemographic-matched emmetropic volunteers without consanguinity serve as controls. |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We enrolled HM participants characterized by AL ≥ 26.00 mm or SE ≤ -6.00 D in at least one eye at the Department of Ophthalmology of the First Affiliated Hospital of Zhengzhou University (Zhengzhou, Henan Province, China) from May 2022 to April 2023 as cases and unrelated normal volunteers with SE ranging from -0.50 D to +0.50 D as controls.
Key inclusion criteria (1 listed)
- HM participants are characterized by AL ≥ 26.00 mm or SE ≤ -6.00 D in at least one eye.
Key exclusion criteria (1 listed)
- Individuals with other ocular or systemic connective tissue diseases were excluded.
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 |
|---|---|---|
| ophthalmologic examinationsAll the included personnel underwent routine ophthalmologic examinations on binoculus, including slit lamp microscope observation, intraocular pressure, diopters of refractive error, best corrected visual acuity, AL measurement, fundus photography and optical coherence tomography, adhering to the established and normalized principles. | Diagnostic test | Control, High myopia |
Primary outcome
diopter
Time frame: 1 hour
This study performs the subgroup analysis based on SE (≤ -20.00 D, -20.00 ~ -15.00 D, -15.00 ~ -10.00 D, and -10.00 ~ -6.00 D) to clarify the correlation between different genetic SNPs and HM inclination more thoroughly.
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 12 Jan 2024.
- Background: PubMed 29451543Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Res Integr Peer Rev. 2016 May 3;1:2. doi: 10.1186/s41073-016-0007-6. eCollection 2016.
- Derived from this study: PubMed 41076047Gao W, Zhang M, An G, Yang F, Li L, Jin X, Du L. The association of ARR3 genetic polymorphisms with pathologic myopia in Northern Chinese population. Exp Eye Res. 2025 Dec;261:110691. doi: 10.1016/j.exer.2025.110691. Epub 2025 Oct 9.
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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.
Liping Du study chair
The First Affiliated Hospital of Zhengzhou 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 The First Affiliated Hospital of Zhengzhou 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 1 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 12 Jan 2024. 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?
diopter (time frame: 1 hour). 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 NCT06204211, 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 12 Jan 2024.