Comparing Relative Peripheral Refraction on Myopia Progression

NCT06758843 | Completed DMC

• 2 other identifiers: Ningbo Eye Hospital2020Y55
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

Myopia progression; Peripheral myopia defocus; children; Refraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Superior peripheral myopic defocus (D)

  12 months

• peripheral refraction difference value 15 degree (D)

  12 months

• Peripheral refraction difference value-30 (D)

  12 months

• refraction difference value- 45 which indicate the average peripheral refractive error at 45◦ of the posterior retina (D)

  12 months

• relative refraction difference value-inferior (D）

  12 months

Study Arms (2)

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

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

Interventions

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

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

Fast progression group of myopia; Slow progression group of myopia

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fuzhou Southeast Institute of Visual Ophthalmology: lead

Study Sites (1)

Ningbo Eye Hospital

Ningbo, Zhejiang, 315000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

ocular axial length, visual acuity, refractive error, peripheral retina refraction parameters such as total MRT value of both eyes, 15 degree MRT value, 30 degree MRT value, 45 degree MRT values, superior MRT values, inferior MRT values, nasal MRT values, temporal MRT values.

MeSH Terms

Conditions

Myopia

Interventions

Visual Acuity

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: July 23, 2022
• Primary Completion: December 29, 2024
• Study Completion: December 29, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)