NCT07030153

Brief Summary

This study aims to identify genetic factors linked to myopia, including those that influence a person's risk of developing it and how quickly it progresses (like changes in eye length). It will also examine how different treatments-such as low-dose atropine drops, orthokeratology lenses, specialized glasses, and increased outdoor time-interact with these genes. Finally, the research will develop a genetic risk score to help tailor personalized myopia prevention and treatment plans.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jul 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Jul 2025Dec 2028

First Submitted

Initial submission to the registry

April 22, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

3.2 years

First QC Date

April 22, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

Myopiageneticintervention

Outcome Measures

Primary Outcomes (1)

  • Polygenic Risk Score (PRS) for Myopia Progression

    1. Measure the Myopia Progression Rate (Change in Diopters/year) * Measurement Tool: Autorefractor (Topcon KR-8900) * Method: Spherical equivalent refraction (SER) will be measured at baseline and every 6 months, with the annual rate of change (ΔD/year) calculated. * Unit: Diopters (D) 2. Measure the Axial Length Growth Rate (mm/year) * Measurement Tool: Optical Biometer (Zeiss IOLMaster 700) * Method: Axial length (AL) will be measured at baseline and every 6 months, with the annual rate of change (Δmm/year) calcu 3. Genetic Risk Assessment Model * Measurement Tool: Candidate genetic loci will be screened using whole-exome sequencing (WES)or genome-wide association study (GWAS). * A PRS model for myopia progression will be constructed by integrating refractive error (SER) and axial length changes using LASSO, DBSLMM or LDpred2 regression. * The correlation between PRS and myopia progression rate will be evaluated (R² or AUC curve).

    Every 6 months for 3 years

Secondary Outcomes (1)

  • Genotype-Guided Decision Tree for Myopia Control Interventions

    Every 6 months for 3 years

Study Arms (2)

Genetic and myopia onset

Identify genetic variants (GWAS/WES) associated with: * Myopia onset risk (high-risk SNPs ). * Myopia progression rate (e.g., axial elongation/year).

Genetic: Oral swab DNA analyzed for myopia-related gene variants

Genetic and myopia intervention

Evaluate gene-intervention interactions for: * Low-dose atropine (0.01%, 0.05%). * Orthokeratology. * Defocus-incorporated spectacles. * Outdoor/sunlight exposure (≥2 hours/day).

Genetic: Oral swab DNA analyzed for myopia-related gene variants

Interventions

Beyond detecting links between gene variants and myopia development, the testing analyzes how these variants influence treatment effectiveness. The aim is to enable early risk prediction and personalized treatment guidance for children through oral DNA testing.

Genetic and myopia interventionGenetic and myopia onset

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Not limited to any specific population group

You may qualify if:

  • Age 6-18 years.
  • Any Spherical equivalent refraction (SER)
  • Parental consent for genetic testing.

You may not qualify if:

  • Suspected genetic syndromes (e.g., Stickler, Marfan).
  • Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
  • Prior refractive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing New Vision Eye Hospital

Beijing, 100020, China

RECRUITING

Beijing Visionly Plus Eye Hospital

Beijing, 100020, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Oral swab DNA

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2025

First Posted

June 22, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 22, 2025

Record last verified: 2025-06

Locations