MyopiaNCT07030153
Association of Genetic Variants With Myopia
An observational study of Myopia, run by Beijing Visionly Plus Eye Hospital at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Oral swab DNA analyzed for myopia-related gene variants
- Type of treatment
- Pill or oral medicine
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Not limited to any specific population group
Who may be able to join
- Age 6-18 years.
- Any Spherical equivalent refraction (SER)
- Parental consent for genetic testing.
Who cannot join
- Suspected genetic syndromes (e.g., Stickler, Marfan).
- Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
- Prior refractive surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing New Vision Eye Hospital
Beijing, 100020
Lin Yang, +86-17898805125, roc001cn@gmail.com
- Recruiting
Beijing Visionly Plus Eye Hospital
Beijing, 100020
Lin Yang, +8617898805125, roc001cn@gmail.com
About this study
Official title: Genetic Variants and Their Association With Myopia Risk, Progression, and Optimal Interventions in Children
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.
- Conditions
- Myopia
- Being tested
- Oral swab DNA analyzed for myopia-related gene variants
- Keywords
- Myopia, genetic, intervention
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral swab DNA analyzed for myopia-related gene variantsGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Genetic: Oral swab DNA analyzed for myopia-related gene variants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polygenic Risk Score (PRS) for Myopia Progression
- 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)
- 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
- 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).
Measured: Every 6 months for 3 years
Secondary outcomes (1)
Genotype-Guided Decision Tree for Myopia Control Interventions
- Data Collection
- error (spherical equivalent, ΔD/year) - Measured via autorefractor (per Primary Outcome Measure)
- Axial length (Δmm/year) - Measured via optical biometer (per Secondary Outcome Measure)
- Genetic Data: Myopia-associated SNPs (derived from WES/GWAS)
- Clinical Intervention Data: Type of myopia control intervention (e.g., 0.01% atropine, orthokeratology, defocus-incorporated spectacles, myopia-control soft contact lenses)
- Analytical Pipeline
- Compute individual PRS by aggregating weighted risk alleles (SNP effect sizes from GWAS or WES)
- Optimal Intervention Stratification
- Apply logistic regression/decision tree analysis to:Identify PRS threshold(s) predictive of treatment response. Test hypotheses ( "Subjects with PRS >X exhibit superior efficacy with atropine vs. orthokeratology")
- Clinical Translation
- Generate decision trees or nomograms to visualize:
- PRS-guided intervention selection
- Predicted treatment efficacy probabilities
Measured: Every 6 months for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Visionly Plus Eye Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing New Vision Eye Hospital, High Myopia Control Alliance (HIMALAYA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030153
- Sponsor's protocol ID
- Precvision202501
- Status last verified
- Jun 2025
- First submitted
- 22 Apr 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variants and Their Association With Myopia Risk, Progression, and Optimal Interventions in Children
- ClinicalTrials.gov ID
- NCT07030153
- Acronym / sponsor ID
- Precvision202501
- Conditions
- Myopia
- Keywords
- Myopia, genetic, intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Visionly Plus Eye HospitalUniversity, hospital or other
- Collaborators
- Beijing New Vision Eye Hospital, High Myopia Control Alliance (HIMALAYA)
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genetic and myopia onset | – | Genetic: Oral swab DNA analyzed for myopia-related gene variantsIdentify genetic variants (GWAS/WES) associated with: * Myopia onset risk (high-risk SNPs ). * Myopia progression rate (e.g., axial elongation/year). |
| Genetic and myopia intervention | – | Genetic: Oral swab DNA analyzed for myopia-related gene variantsEvaluate gene-intervention interactions for: * Low-dose atropine (0.01%, 0.05%). * Orthokeratology. * Defocus-incorporated spectacles. * Outdoor/sunlight exposure (≥2 hours/day). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Not limited to any specific population group
Key inclusion criteria (3 listed)
- Age 6-18 years.
- Any Spherical equivalent refraction (SER)
- Parental consent for genetic testing.
Key exclusion criteria (3 listed)
- Suspected genetic syndromes (e.g., Stickler, Marfan).
- Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
- Prior refractive surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral swab DNA analyzed for myopia-related gene variantsBeyond 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 | Genetic and myopia intervention, Genetic and myopia onset |
Primary outcome
Polygenic Risk Score (PRS) for Myopia Progression
Time frame: Every 6 months for 3 years
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).
1 secondary outcome
Genotype-Guided Decision Tree for Myopia Control Interventions
Time frame: Every 6 months for 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Beijing Visionly Plus Eye Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Yang, M.D. (+86-17898805125, roc001cn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polygenic Risk Score (PRS) for Myopia Progression (time frame: Every 6 months for 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.