MyopiaNCT05250440
Noninvasive and Dynamic Monitoring the Biological Parameters of Eyes in Different Age Groups
An observational study of Myopia, run by Zhongnan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 1. Resident population in Hubei Province 2. No gender preference 3. Healthy population aged between 12 and 35
Who may be able to join
- Resident population in Hubei Province
- No gender preference
- Healthy population aged between 12 and 35
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Min Ke, Doctor, +86-18672395959, keminyk@163.com
About this study
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.
Read the 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.
- Conditions
- Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| (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 being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Axial length was measured by IOL Master700 partially coherent interferometry.
Measured: 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).
Measured: 10 am to 12 am, every day
Posterior scleral thickness
Spectralis HRA+OCT images used to determine posterior scleral thickness under fovea.
Measured: 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).
Measured: 10 am to 12 am, every day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Ke, Doctor, Study director, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250440
- Sponsor's protocol ID
- 2022020901
- Status last verified
- Feb 2022
- First submitted
- 10 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: gender, age, refractive diopter, best corrected visual acuity, ocular axial length, anterior scleral thickness, choroid thickness, posterior scleral thickness
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive and Dynamic Monitoring the Biological Parameters of Eyes in Different Age Groups
- ClinicalTrials.gov ID
- NCT05250440
- Acronym / sponsor ID
- 2022020901
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Feb 2022 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| (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 |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 1. Resident population in Hubei Province 2. No gender preference 3. Healthy population aged between 12 and 35
Key inclusion criteria (3 listed)
- Resident population in Hubei Province
- No gender preference
- Healthy population aged between 12 and 35
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Axial length
Time frame: 10 am to 12 am, every day
Axial length was measured by IOL Master700 partially coherent interferometry.
Anterior scleral thickness
Time frame: 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).
Posterior scleral thickness
Time frame: 10 am to 12 am, every day
Spectralis HRA+OCT images used to determine posterior scleral thickness under fovea.
Choroid thickness
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Undecided. gender, age, refractive diopter, best corrected visual acuity, ocular axial length, anterior scleral thickness, choroid thickness, posterior scleral thickness
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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.
Min Ke, Doctor study director
Wuhan University
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 Zhongnan 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Ke, Doctor (+86-18672395959, keminyk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 10 am to 12 am, every day). The study lists 4 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 14 Mar 2022.