Comparing Relative Peripheral Refraction on Myopia Progression

NCT ID: NCT06758843

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-23
• Study Completion Date: 2024-12-29

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.

Conditions

Myopia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fast progression group of myopia

The axial length elongation is equal or larger than 0.40 mm per year

measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-month

Intervention Type: OTHER

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

measure the axial length, visual acuity, and refraction at follow-up of 6- and 12-month

Intervention Type: OTHER

the intervention is follow-up with parameters to measure and data to record

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fuzhou Southeast Institute of Visual Ophthalmology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ningbo Eye Hospital

Ningbo, Zhejiang, China

Countries

China

Other Identifiers

2020Y55

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Ningbo Eye Hospital

Identifier Type: -

Identifier Source: org_study_id