Comparing Relative Peripheral Refraction on Myopia Progression (CMPMRT)

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:

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Other: measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-month

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 Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Ningbo Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

children in primary school and middle school, heathy or myopia at baseline

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Without data of primary outcome
• With only one measurement
• Others condition that investigators consider not elilgible

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fast progression group of myopia; The axial length elongation is equal or larger than 0.40 mm per year	Other: measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-month; the intervention is follow-up with parameters to measure and data to record
Slow progression group of myopia; The axial length elongation is less than 0.30 mm per year	Other: measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-month; the intervention is follow-up with parameters to measure and data to record

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total value of relative peripheral refraction from MRT (D)	The parameter obtained using MRT for analysis is = total peripheral refraction - central refractive error.	12 months
Total relative peripheral refraction from MRT (D)	The parameter obtained using MRT for analysis; total peripheral refraction error - central refractive error	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superior peripheral myopic defocus (D)	which indicates the average peripheral refractive error from the center to the peripheral of superior area of the retina.	12 months
peripheral refraction difference value 15 degree (D)	which indicates the average paracentral refractive error from the center to 15◦ of the retina	12 months
Peripheral refraction difference value-30 (D)	which indicate the average peripheral refractive error at 30 ◦	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	12 months
relative refraction difference value-inferior (D）	the relative refraction difference value of inferior, which is measured by MRT	12 months
relative refraction difference value-nasal (D)	the relative refraction difference value-nasal measured by MRT	12 months
relative refraction difference value-temporal (D).	the relative refraction difference value-temporal measured by MRT.	12 months
Change of refractive error (D)	the change of refractive error is measured by auto-refractor without cycloplegia	12 months
Visual acuity (decimal )	the visual acuity is test with decimal visual acuity chart at distance	12 months
Visual acuity (decimal )	the visual acuity is test with decimal visual acuity chart at distance	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.	6 months
peripheral refraction difference value 15 degree (D)	which indicates the average paracentral refractive error from the center to 15◦ of the retina	6 months
Change of refractive error (D)	the change of refractive error is measured by auto-refractor without cycloplegia	6 months
relative refraction difference value-inferior (D）	the relative refraction difference value of inferior, which is measured by MRT	6 months
relative refraction difference value-nasal (D)	the relative refraction difference value-nasal measured by MRT	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	6 months
Peripheral refraction difference value-30 (D)	which indicate the average peripheral refractive error at 30 ◦	6 months

Collaborators and Investigators

• Sponsor: Fuzhou Southeast Institute of Visual Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2022
• Primary Completion (Actual): December 29, 2024
• Study Completion (Actual): December 29, 2024

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: December 29, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: children; Refraction; Myopia progression; Peripheral myopia defocus
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Eye Diseases; Refractive Errors; Myopia; Disease Progression
• Other Study ID Numbers: Ningbo Eye Hospital; 2020Y55 (Other Grant/Funding Number: the Science and Technology Program of Ningbo, China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No