Impact of Ultraviolet Radiation and Environmental Factors on Human Ocular Biomechanics

NCT06993077 | Active Not Recruiting

• 1 other identifier: KY-2025010
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Corneal Biomechanical Parameters Measured by Corvis ST

  Central corneal thickness (CCT) mm

  Baseline (at time of examination)

• Corneal Biomechanical Parameters Measured by Corvis ST

  ,biomechanically corrected intraocular pressure (bIOP) mmHg

  Baseline (at time of examination)

Interventions

environment Exposure OTHER

No special intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

China, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 28, 2025
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-04

Locations

CN (1)