Comparing Relative Peripheral Refraction on Myopia Progression

Completed

• Conditions: Myopia

• Registration Number: NCT06758843
• Lead Sponsor: Fuzhou Southeast Institute of Visual Ophthalmology

Brief 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 (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 Timeline

• Study Start: 2022-07-23
• Primary Completion: 2024-12-29
• Study Completion: 2024-12-29
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2024-12-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-04
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Superior peripheral myopic defocus (D)	6 months	which indicates the average peripheral refractive error from the center to the peripheral of superior area of the retina.
peripheral refraction difference value 15 degree (D)	6 months	which indicates the average paracentral refractive error from the center to 15◦ of the retina
Peripheral refraction difference value-30 (D)	6 months	which indicate the average peripheral refractive error at 30 ◦
refraction difference value- 45 which indicate the average peripheral refractive error at 45◦ of the posterior retina (D)	6 months	the relative refraction difference value- 45which indicate the average peripheral refractive error at 45◦ of the posterior retina measured by MRT
relative refraction difference value-inferior (D）	6 months	the relative refraction difference value of inferior, which is measured by MRT
relative refraction difference value-nasal (D)	6 months	the relative refraction difference value-nasal measured by MRT
relative refraction difference value-temporal (D).	12 months	the relative refraction difference value-temporal measured by MRT.
Change of refractive error (D)	6 months	the change of refractive error is measured by auto-refractor without cycloplegia
Visual acuity (decimal )	6 months	the visual acuity is test with decimal visual acuity chart at distance

Trial Locations

Locations (1)

Ningbo Eye Hospital; 🇨🇳 Ningbo, Zhejiang, China