Clinical trial NCT06204211: Genetic Research on High Myopic Individuals in Northern China
Official title: Genetic Research on High Myopic Individuals in Northern China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Myopia
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 1340
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: diopter
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Liping Du
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Liping Du
role: STUDY_CHAIR
References:
citation: 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.