Genetic Research on High Myopic Individuals in Northern China

High Myopia Clinical Trial

Official title:

Genetic Research on High Myopic Individuals in Northern China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06204211
• Other study ID #: 2022-KY-0512-002
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• High Myopia
• Myopia

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