MyopiaNCT06993077
Impact of Ultraviolet Radiation and Environmental Factors on Human Ocular Biomechanics
An observational study of Myopia, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
This observational study aims to explore whether ultraviolet (UV) radiation and other environmental factors are associated with ocular biomechanical properties in healthy volunteers aged 18-44 years without ocular diseases, ocular surgery history, or systemic diseases. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- environment Exposure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Oct 2025
- 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 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will include individuals aged 18 to 44 years who are undergoing routine ophthalmic examinations across multiple medical centers. Participants must have no history of ocular or systemic diseases and meet specific refractive criteria. Only one eye per subject will be analyzed, and all biomechanical measurements will be performed using the same model of Corvis ST device to ensure consistency.
Who may be able to join
- Age between 18 and 44 years (based on WHO criteria);
- Spherical equivalent refraction (SER) ≤ 6.00 diopters;
- No other ocular diseases;
- No systemic diseases (e.g., diabetes, hypertension, cardiovascular diseases);
- No severe psychiatric or psychological disorders;
- No history of ocular surgery.
Who cannot join
- Severe psychiatric disorders;
- Individuals diagnosed with keratoconus, suspected keratoconus, or subclinical keratoconus (based on the Global Consensus on Keratoconus Diagnosis);
- Presence of other ocular diseases (e.g., glaucoma, corneal opacity, uveitis);
- History of intraocular or ocular surface surgeries;
- Presence of nystagmus or inability to cooperate with examinations;
- History of intraocular surgery;
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- Presence of systemic diseases (e.g., diabetes, hypertension, cardiovascular diseases).
- Severe psychiatric disorders;
- Individuals diagnosed with keratoconus, suspected keratoconus, or subclinical keratoconus (based on the Global Consensus on Keratoconus Diagnosis);
- Presence of other ocular diseases (e.g., glaucoma, corneal opacity, uveitis);
- History of intraocular or ocular surface surgeries;
- Presence of nystagmus or inability to cooperate with examinations;
- History of intraocular surgery;
- Presence of systemic diseases (e.g., diabetes, hypertension, cardiovascular diseases).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Ultraviolet Radiation, Environmental Factors, and Ocular Biomechanical Properties: A Multicenter Cross-Sectional Study
This observational study aims to explore whether ultraviolet (UV) radiation and other environmental factors are associated with ocular biomechanical properties in healthy volunteers aged 18-44 years without ocular diseases, ocular surgery history, or systemic diseases.
The main questions it aims to answer are:
Read more
Is there a significant correlation between UV radiation levels and corneal biomechanical parameters?
Do environmental factors such as geographic region and seasonal variation affect corneal biomechanical behavior?
Researchers will compare ocular biomechanical parameters among populations from different geographic regions with varying levels of UV radiation to determine whether there are statistically significant correlations or differences.
Participants will:
Undergo standardized ophthalmic examinations, including visual acuity, intraocular pressure, slit-lamp evaluation, axial length, and corneal topography;
Receive corneal biomechanical assessments using the Corvis ST device;
Provide basic demographic information and medical history;
Have all data de-identified, with the study strictly following ethical approval and privacy protection protocols.
- Conditions
- Myopia
- Being tested
- environment Exposure
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
environment ExposureOther
No special intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Biomechanical Parameters Measured by Corvis ST
Central corneal thickness (CCT) mm
Measured: Baseline (at time of examination)
Corneal Biomechanical Parameters Measured by Corvis ST
,biomechanically corrected intraocular pressure (bIOP) mmHg
Measured: Baseline (at time of examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start1 Jan 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Oct 2025 (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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993077
- Sponsor's protocol ID
- KY-2025010
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Ultraviolet Radiation, Environmental Factors, and Ocular Biomechanical Properties: A Multicenter Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06993077
- Acronym / sponsor ID
- KY-2025010
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 28 May 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 observational study aims to explore whether ultraviolet (UV) radiation and other environmental factors are associated with ocular biomechanical properties in healthy volunteers aged 18-44 years without ocular diseases, ocular surgery history, or systemic diseases.
The main questions it aims to answer are:
Is there a significant correlation between UV radiation levels and corneal biomechanical parameters?
Do environmental factors such as geographic region and seasonal variation affect corneal biomechanical behavior?
Researchers will compare ocular biomechanical parameters among populations from different geographic regions with varying levels of UV radiation to determine whether there are statistically significant correlations or differences.
Participants will:
Undergo standardized ophthalmic examinations, including visual acuity, intraocular pressure, slit-lamp evaluation, axial length, and corneal topography;
Receive corneal biomechanical assessments using the Corvis ST device;
Provide basic demographic information and medical history;
Have all data de-identified, with the study strictly following ethical approval and privacy protection protocols.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will include individuals aged 18 to 44 years who are undergoing routine ophthalmic examinations across multiple medical centers. Participants must have no history of ocular or systemic diseases and meet specific refractive criteria. Only one eye per subject will be analyzed, and all biomechanical measurements will be performed using the same model of Corvis ST device to ensure consistency.
Key inclusion criteria (6 listed)
- Age between 18 and 44 years (based on WHO criteria);
- Spherical equivalent refraction (SER) ≤ 6.00 diopters;
- No other ocular diseases;
- No systemic diseases (e.g., diabetes, hypertension, cardiovascular diseases);
- No severe psychiatric or psychological disorders;
Key exclusion criteria (14 listed)
- Severe psychiatric disorders;
- Individuals diagnosed with keratoconus, suspected keratoconus, or subclinical keratoconus (based on the Global Consensus on Keratoconus Diagnosis);
- Presence of other ocular diseases (e.g., glaucoma, corneal opacity, uveitis);
- History of intraocular or ocular surface surgeries;
- Presence of nystagmus or inability to cooperate with examinations;
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 |
|---|---|---|
| environment ExposureNo special intervention | Other | – |
Primary outcome
Corneal Biomechanical Parameters Measured by Corvis ST
Time frame: Baseline (at time of examination)
Central corneal thickness (CCT) mm
Corneal Biomechanical Parameters Measured by Corvis ST
Time frame: Baseline (at time of examination)
,biomechanically corrected intraocular pressure (bIOP) mmHg
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 28 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Tianjin Eye Hospital at 1 site 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 6 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Biomechanical Parameters Measured by Corvis ST (time frame: Baseline (at time of examination)). The study lists 2 primary outcomes in all. 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 28 May 2025.