Genetic Research on High Myopic Individuals in Northern China

Completed

• Conditions: High Myopia
• Interventions: Diagnostic Test: ophthalmologic examinations

• Registration Number: NCT06204211
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-08-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Study First Posted: 2024-01-12
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1340

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High myopia	ophthalmologic examinations	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.
Control	ophthalmologic examinations	Demographic-matched emmetropic volunteers without consanguinity serve as controls.

Primary Outcome Measures

Name	Time	Method
diopter	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.

Trial Locations

Locations (1)

Liping Du; 🇨🇳 Zhengzhou, Henan, China