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

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia

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 Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Min Ke, Doctor; Phone Number: +86-18672395959; Email: keminyk@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Recruiting
      • Zhongnan Hospital of Wuhan University
      • Contact: Min Ke, Doctor; Phone Number: +86-18672395959; Email: keminyk@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Resident population in Hubei Province
2. No gender preference
3. Healthy population aged between 12 and 35

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
(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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhongnan Hospital
• Investigators: Study Director: Min Ke, Doctor, Wuhan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (ACTUAL): February 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2022020901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: gender, age, refractive diopter, best corrected visual acuity, ocular axial length, anterior scleral thickness, choroid thickness, posterior scleral thickness

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No