Noninvasive and Dynamic Monitoring the Biological Parameters of Eyes in Different Age Groups
1 other identifier
observational
240
1 country
1
Brief Summary
Myopia is the most common refractive eye disease worldwide. The number of cases is up to 2 billion. In recent years, the incidence of myopia in China is obviously rising trend. As early as the 2018 national health committee epidemiological data show that teenage myopia rate in China has been the first in the world, and has become the influence in China, especially the youth eye health major public health problem. In recent years, prevention and control measures for myopia have emerged in endlessly, such as increasing outdoor activity time, sufficient sunlight exposure, orthokeratology and local use of low-concentration atropine can partially prevent the occurrence or slow down the progression of myopia. But the effects are limited and cannot completely inhibit the development of myopia. In recent years, with the in-depth study of myopia, it is found that myopia is not only the change of diopter, but also the pathological changes of the whole eyeball shape and corresponding tissues. The incidence of myopia is closely related to the biological parameters of the eyeball, which has become a hotspot of clinical research in recent years. Current studies believe that eyeball biological parameters such as axial length, scleral thickness, choroid thickness are related to the occurrence of myopia, among which the change of scleral structure and shape, namely scleral remodeling, is considered to be an important factor in all visual stimuli leading to myopia. A large number of studies have also shown that scleral remodeling can lead to changes in the scleral biomechanics, thereby promoting the development of myopia. Multiple studies have shown a negative correlation between myopia and scleral thickness, with the thinning of the lower anterior sclera being the most significant. The lower anterior sclera is considered to be a marker for predicting the development of myopia, but some studies have found no correlation between the two. Such differences in the results may be related to the precision of the measurement instrument, the sample size of the included cases, age, and the grouping of different refractive states. The correlation between various biological parameters of the eyeball, especially the sclera, and myopia is not clear at present. Therefore, more penetrating and clearer instruments, more sample sizes, and more scientific grouping are needed for further research and confirmation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Typical duration for all trials
1 active site
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 Start
First participant enrolled
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 14, 2022
February 1, 2022
2.9 years
February 10, 2022
February 24, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Axial length
Axial length was measured by IOL Master700 partially coherent interferometry.
10 am to 12 am, every day
Anterior scleral thickness
Anterior segment OCT images used to determine anterior scleral thickness obtained by gazing in 4 directions (superior, temporal, inferior, and nasal).
10 am to 12 am, every day
Posterior scleral thickness
Spectralis HRA+OCT images used to determine posterior scleral thickness under fovea.
10 am to 12 am, every day
Choroid thickness
Spectralis HRA+OCT images used to determine choroid thickness obtained by gazing in 4 directions (superior, temporal, inferior, and nasal).
10 am to 12 am, every day
Study Arms (8)
(a1)Emmetropia: +0.75 to -0.75 D
age: 12 to 18 years old
(a2)Mild myopia: -1.00 to -3.00 D
age: 12 to 18 years old
(a3)Moderate myopia: -3.25 to -6.00 D
age: 12 to 18 years old
(a4)High myopia: >-6.00 D
age: 12 to 18 years old
(b1)Emmetropia: +0.75 to -0.75 D
age: 18 to 35 years old
(b2)Mild myopia: -1.00 to -3.00 D
age: 18 to 35 years old
(b3)Moderate myopia: -3.25 to -6.00 D
age: 18 to 35 years old
(b4)High myopia: >-6.00 D
age: 18 to 35 years old
Eligibility Criteria
1. Resident population in Hubei Province 2. No gender preference 3. Healthy population aged between 12 and 35
You may qualify if:
- Resident population in Hubei Province
- No gender preference
- Healthy population aged between 12 and 35
You may not qualify if:
- Systemic diseases
- History of other eye diseases, surgery and/or medications, and eye trauma
- Anisometropia \> 2.00 D
- Astigmatism \> 2.00 D
- The best corrected visual acuity was less than 0.8
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Min Ke, Doctor
Wuhan University
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
February 10, 2022
First Posted
February 22, 2022
Study Start
February 1, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
March 14, 2022
Record last verified: 2022-02