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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06204211
Other study ID # 2022-KY-0512-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date August 31, 2023

Study information

Verified date January 2024
Source The First Affiliated Hospital of Zhengzhou University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1340
Est. completion date August 31, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 80 Years
Eligibility Inclusion Criteria: - HM participants are characterized by AL = 26.00 mm or SE = -6.00 D in at least one eye. Exclusion Criteria: - Individuals with other ocular or systemic connective tissue diseases were excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ophthalmologic examinations
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.

Locations

Country Name City State
China Liping Du Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 hour
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