Noninvasive and Dynamic Monitoring the Biological Parameters of Eyes in Different Age Groups

Sponsor
Zhongnan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05250440
Collaborator
(none)
240
1
35
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Department of Ophthalmology, Zhongnan Hospital of Wuhan University, has a variety of the most advanced instruments and equipment in the world, such as the newly listed TOMEY CASIA2, which is non-invasive and non-contact, and can quickly obtain the living body tomography of the anterior part of the eye tissue structure at one time, and can conduct quantitative analysis. The latest generation of Ultra Wide Angle fundus imager (Optoc) that is, under the small pupil to obtain nearly 200 degrees fundus image, Heidelberg confocal fundus diagnostic instrument, IOL MASTER700 biometric instrument, etc. This topic is proposed to use an eye the forefront of the latest generation of instruments and equipment, to emmetropia, mild myopia, moderate myopia and high myopia eyeball all biological parameters measurement, explore various biological parameters and the correlation of myopia, for myopia prevention and control such as nearsightedness in the process of the follow-up biological indicators need to focus on monitoring, provide powerful clinical basis.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Noninvasive and Dynamic Monitoring the Biological Parameters of Eyes in Different Age Groups
    Actual Study Start Date :
    Feb 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    (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

    Outcome Measures

    Primary Outcome Measures

    1. Axial length [10 am to 12 am, every day]

      Axial length was measured by IOL Master700 partially coherent interferometry.

    2. Anterior scleral thickness [10 am to 12 am, every day]

      Anterior segment OCT images used to determine anterior scleral thickness obtained by gazing in 4 directions (superior, temporal, inferior, and nasal).

    3. Posterior scleral thickness [10 am to 12 am, every day]

      Spectralis HRA+OCT images used to determine posterior scleral thickness under fovea.

    4. Choroid thickness [10 am to 12 am, every day]

      Spectralis HRA+OCT images used to determine choroid thickness obtained by gazing in 4 directions (superior, temporal, inferior, and nasal).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Resident population in Hubei Province

    • No gender preference

    • Healthy population aged between 12 and 35

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430071

    Sponsors and Collaborators

    • Zhongnan Hospital

    Investigators

    • Study Director: Min Ke, Doctor, Wuhan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhongnan Hospital
    ClinicalTrials.gov Identifier:
    NCT05250440
    Other Study ID Numbers:
    • 2022020901
    First Posted:
    Feb 22, 2022
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 14, 2022