MyopiaCMPMRTNCT06758843
Comparing Relative Peripheral Refraction on Myopia Progression
An observational study of Myopia, run by Fuzhou Southeast Institute of Visual Ophthalmology at 1 site in China.
Trial summary
The investigators will test our hypothesis that parameters on peripheral defocus can regulate eye growth: For instance, the relative peripheral refraction measured by Multispectral Refraction Topography (MRT) would be significant different between two groups: fast speed and slow speed of axial length elongation… Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-month
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2022to 29 Dec 2024
- How long will I take part?
- 2 Years
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children in primary school and middle school, heathy or myopia at baseline
Who may be able to join
- Will to attend the baseline and all the follow-ups
- Sign the Inform Consent Form
- Could co-operate to ask for the correction and accept the axial length measurement and refraction devices including MRT
- Without eye surgery and trauma history
- His/Her refractive error and axial length could be measured
Who cannot join
- Without data of primary outcome
- With only one measurement
- Others condition that investigators consider not elilgible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Controlled, Parallel Trial of Comparing Relative Peripheral Refraction Between Parameters Before and After Myopia Progression with Multispectral Refraction Topography
The investigators will test our hypothesis that parameters on peripheral defocus can regulate eye growth: For instance, the relative peripheral refraction measured by Multispectral Refraction Topography (MRT) would be significant different between two groups: fast speed and slow speed of axial length elongation (myopia progression) for 1 year with 2-3 follow-ups.
The goal of this observation study is to confirm the value of MRT in clinic. Could it predict myopia progression or not? By the parameters on relative peripheral refraction in children myopia, could include any of the following: both genders, 7~17 years age groups, including healthy volunteers. The main question it aims to answer is:
Read more
Is any of relative peripheral refraction parameters measured by MRT could guide the clinics for predict myopia progression? Which parameters from MRT could predict the myopia fast progression at baseline ? There is a comparison between groups. Researchers will compare fast myopia progression group versus slow myopia progression group to see if any parameters differs at baseline.
Participants will be asked to the collection methods (such as spectacles, orhtokeratology, contact lens) and interventions; And each participant would be followed up for at least 2 times in one year to test the axial length and refractive error as well as parameters with MRT.
Read the detailed description
Visual signals from the surrounding retina play a crucial role in the process of emmetropization in the peripheral area of retina and may be a key factor in the development of myopia.
Peripheral defocus can regulate eye growth, particularly peripheral hyperopic defocus, which is a high-risk factor for promoting eye growth and the onset and progression of myopia.
In recent years, with the establishment of new experimental animal models and the emergence of new detection technologies, the relationship between peripheral defocus and myopia has received increasing attention.
The axial length of the eye is the most important indicator for assessing myopia progression.
About 7000 students from Ningbo would be follow-up for the MRT and their myopia progression for at least 1 year.
- Conditions
- Myopia
- Being tested
- measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-month
- Keywords
- Myopia progression, Peripheral myopia defocus, children, Refraction
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-monthOther
the intervention is follow-up with parameters to measure and data to record
| Study group | Role | What they receive |
|---|---|---|
| Fast progression group of myopia | The axial length elongation is equal or larger than 0.40 mm per year Receives: Other: measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-month | |
| Slow progression group of myopia | The axial length elongation is less than 0.30 mm per year Receives: Other: measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total value of relative peripheral refraction from MRT (D)
The parameter obtained using MRT for analysis is = total peripheral refraction - central refractive error.
Measured: 12 months
Total relative peripheral refraction from MRT (D)
The parameter obtained using MRT for analysis
- total peripheral refraction error - central refractive error
Measured: 6 months
Secondary outcomes (17)
Superior peripheral myopic defocus (D)
which indicates the average peripheral refractive error from the center to the peripheral of superior area of the retina.
Measured: 12 months
peripheral refraction difference value 15 degree (D)
which indicates the average paracentral refractive error from the center to 15◦ of the retina
Measured: 12 months
Peripheral refraction difference value-30 (D)
which indicate the average peripheral refractive error at 30 ◦
Measured: 12 months
refraction difference value- 45 which indicate the average peripheral refractive error at 45◦ of the posterior retina (D)
the relative refraction difference value- 45which indicate the average peripheral refractive error at 45◦ of the posterior retina measured by MRT
Measured: 12 months
relative refraction difference value-inferior (D）
the relative refraction difference value of inferior, which is measured by MRT
Measured: 12 months
relative refraction difference value-nasal (D)
the relative refraction difference value-nasal measured by MRT
Measured: 12 months
relative refraction difference value-temporal (D).
the relative refraction difference value-temporal measured by MRT.
Measured: 12 months
Change of refractive error (D)
the change of refractive error is measured by auto-refractor without cycloplegia
Measured: 12 months
Visual acuity (decimal )
the visual acuity is test with decimal visual acuity chart at distance
Measured: 12 months
Visual acuity (decimal )
the visual acuity is test with decimal visual acuity chart at distance
Measured: 6 months
Superior peripheral myopic defocus (D)
which indicates the average peripheral refractive error from the center to the peripheral of superior area of the retina.
Measured: 6 months
peripheral refraction difference value 15 degree (D)
which indicates the average paracentral refractive error from the center to 15◦ of the retina
Measured: 6 months
Change of refractive error (D)
the change of refractive error is measured by auto-refractor without cycloplegia
Measured: 6 months
relative refraction difference value-inferior (D）
the relative refraction difference value of inferior, which is measured by MRT
Measured: 6 months
relative refraction difference value-nasal (D)
the relative refraction difference value-nasal measured by MRT
Measured: 6 months
refraction difference value- 45 which indicate the average peripheral refractive error at 45◦ of the posterior retina (D)
the relative refraction difference value- 45which indicate the average peripheral refractive error at 45◦ of the posterior retina measured by MRT
Measured: 6 months
Peripheral refraction difference value-30 (D)
which indicate the average peripheral refractive error at 30 ◦
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start23 Jul 2022
- Primary completion29 Dec 2024
- Study completion29 Dec 2024
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
- 6,000 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fuzhou Southeast Institute of Visual Ophthalmology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758843
- Sponsor's protocol ID
- Ningbo Eye Hospital
- Other IDs
- 2020Y55
- Acronym
- CMPMRT
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled, Parallel Trial of Comparing Relative Peripheral Refraction Between Parameters Before and After Myopia Progression with Multispectral Refraction Topography
- ClinicalTrials.gov ID
- NCT06758843
- Acronym / sponsor ID
- CMPMRT / Ningbo Eye Hospital
- Conditions
- Myopia
- Keywords
- Myopia progression, Peripheral myopia defocus, children, Refraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Fuzhou Southeast Institute of Visual OphthalmologyUniversity, hospital or other
- Study start
- 23 Jul 2022 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 6 Jan 2025 (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.
The investigators will test our hypothesis that parameters on peripheral defocus can regulate eye growth: For instance, the relative peripheral refraction measured by Multispectral Refraction Topography (MRT) would be significant different between two groups: fast speed and slow speed of axial length elongation (myopia progression) for 1 year with 2-3 follow-ups.
The goal of this observation study is to confirm the value of MRT in clinic. Could it predict myopia progression or not? By the parameters on relative peripheral refraction in children myopia, could include any of the following: both genders, 7~17 years age groups, including healthy volunteers. The main question it aims to answer is:
Is any of relative peripheral refraction parameters measured by MRT could guide the clinics for predict myopia progression? Which parameters from MRT could predict the myopia fast progression at baseline ? There is a comparison between groups. Researchers will compare fast myopia progression group versus slow myopia progression group to see if any parameters differs at baseline.
Participants will be asked to the collection methods (such as spectacles, orhtokeratology, contact lens) and interventions; And each participant would be followed up for at least 2 times in one year to test the axial length and refractive error as well as parameters with MRT.
Detailed description
Visual signals from the surrounding retina play a crucial role in the process of emmetropization in the peripheral area of retina and may be a key factor in the development of myopia.
Peripheral defocus can regulate eye growth, particularly peripheral hyperopic defocus, which is a high-risk factor for promoting eye growth and the onset and progression of myopia.
In recent years, with the establishment of new experimental animal models and the emergence of new detection technologies, the relationship between peripheral defocus and myopia has received increasing attention.
The axial length of the eye is the most important indicator for assessing myopia progression.
About 7000 students from Ningbo would be follow-up for the MRT and their myopia progression for at least 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast progression group of myopia | – | Other: measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-monthThe axial length elongation is equal or larger than 0.40 mm per year |
| Slow progression group of myopia | – | Other: measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-monthThe axial length elongation is less than 0.30 mm per year |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children in primary school and middle school, heathy or myopia at baseline
Key inclusion criteria (5 listed)
- Will to attend the baseline and all the follow-ups
- Sign the Inform Consent Form
- Could co-operate to ask for the correction and accept the axial length measurement and refraction devices including MRT
- Without eye surgery and trauma history
- His/Her refractive error and axial length could be measured
Key exclusion criteria (3 listed)
- Without data of primary outcome
- With only one measurement
- Others condition that investigators consider not elilgible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-monththe intervention is follow-up with parameters to measure and data to record | Other | Fast progression group of myopia, Slow progression group of myopia |
Primary outcome
Total value of relative peripheral refraction from MRT (D)
Time frame: 12 months
The parameter obtained using MRT for analysis is = total peripheral refraction - central refractive error.
Total relative peripheral refraction from MRT (D)
Time frame: 6 months
The parameter obtained using MRT for analysis * total peripheral refraction error - central refractive error
17 secondary outcomes
Superior peripheral myopic defocus (D)
Time frame: 12 months
peripheral refraction difference value 15 degree (D)
Time frame: 12 months
Peripheral refraction difference value-30 (D)
Time frame: 12 months
refraction difference value- 45 which indicate the average peripheral refractive error at 45◦ of the posterior retina (D)
Time frame: 12 months
relative refraction difference value-inferior (D）
Time frame: 12 months
relative refraction difference value-nasal (D)
Time frame: 12 months
relative refraction difference value-temporal (D).
Time frame: 12 months
Change of refractive error (D)
Time frame: 12 months
Visual acuity (decimal )
Time frame: 12 months
Visual acuity (decimal )
Time frame: 6 months
Superior peripheral myopic defocus (D)
Time frame: 6 months
peripheral refraction difference value 15 degree (D)
Time frame: 6 months
Change of refractive error (D)
Time frame: 6 months
relative refraction difference value-inferior (D）
Time frame: 6 months
relative refraction difference value-nasal (D)
Time frame: 6 months
refraction difference value- 45 which indicate the average peripheral refractive error at 45◦ of the posterior retina (D)
Time frame: 6 months
Peripheral refraction difference value-30 (D)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fuzhou Southeast Institute of Visual Ophthalmology 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 7 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total value of relative peripheral refraction from MRT (D) (time frame: 12 months). The study lists 2 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 7 Jan 2025.