Genetic Research on High Myopic Individuals in Northern China

NCT06204211 | Completed DMC

• 1 other identifier: 2022-KY-0512-002
• Study Type: observational
• Target: 1,340
• Locations: 1 country
• Sites: 1

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.

Conditions

High Myopia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Diagnostic Test: ophthalmologic examinations

Control

Demographic-matched emmetropic volunteers without consanguinity serve as controls.

Diagnostic Test: ophthalmologic examinations

Interventions

ophthalmologic examinations DIAGNOSTIC_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.

Control; High myopia

Eligibility Criteria

• Age: 1 Year - 80 Years
• Gender Eligibility Details: The gender of subjects is divided according to the reports of Heidari et al (see the reference 1).
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• HM participants are characterized by AL ≥ 26.00 mm or SE ≤ -6.00 D in at least one eye.

You may not qualify if:

• Individuals with other ocular or systemic connective tissue diseases were excluded.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

Liping Du

Zhengzhou, Henan, 450052, China

Location

Related Publications (2)

• 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.

  PMID: 29451543 BACKGROUND

• Gao 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.

  PMID: 41076047 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood DNA were isolated utilizing the QIAamp DNA Blood Mini Kit (Qiagen, Hilden, North Rhine-Westphalia, Germany). And subsequently, the purity and concentration of obtained DNA were surveyed by the Nanodrop 2000 spectrophotometer (Thermo Fisher Scientific, Wilmington, Delaware, the United States of America), after which the normalization of qualified DNA samples followed. Finally, standardized DNA specimens were hold at -80 ℃ for future use.

Study Officials

• Liping Du

  The First Affiliated Hospital of Zhengzhou University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: May 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: August 31, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

CN (1)