Clinical trial NCT06758843: Comparing Relative Peripheral Refraction on Myopia Progression
Official title: A Prospective, Controlled, Parallel Trial of Comparing Relative Peripheral Refraction Between Parameters Before and After Myopia Progression with Multispectral Refraction Topography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: Myopia progression
Peripheral myopia defocus
children
Refraction
Lead sponsor: Fuzhou Southeast Institute of Visual Ophthalmology
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 6000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children in primary school and middle school, heathy or myopia at baseline

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.

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

Primary outcomes:
measure: Total value of relative peripheral refraction from MRT (D)
timeFrame: 12 months
measure: Total relative peripheral refraction from MRT (D)
timeFrame: 6 months
Secondary outcomes:
measure: Superior peripheral myopic defocus (D)
timeFrame: 12 months
measure: peripheral refraction difference value 15 degree (D)
timeFrame: 12 months
measure: Peripheral refraction difference value-30 (D)
timeFrame: 12 months
measure: refraction difference value- 45 which indicate the average peripheral refractive error at 45◦ of the posterior retina (D)
timeFrame: 12 months
measure: relative refraction difference value-inferior (D）
timeFrame: 12 months
measure: relative refraction difference value-nasal (D)
timeFrame: 12 months
measure: relative refraction difference value-temporal (D).
timeFrame: 12 months
measure: Change of refractive error (D)
timeFrame: 12 months
measure: Visual acuity (decimal )
timeFrame: 12 months
measure: Visual acuity (decimal )
timeFrame: 6 months
measure: Superior peripheral myopic defocus (D)
timeFrame: 6 months
measure: peripheral refraction difference value 15 degree (D)
timeFrame: 6 months
measure: Change of refractive error (D)
timeFrame: 6 months
measure: relative refraction difference value-inferior (D）
timeFrame: 6 months
measure: relative refraction difference value-nasal (D)
timeFrame: 6 months
measure: refraction difference value- 45 which indicate the average peripheral refractive error at 45◦ of the posterior retina (D)
timeFrame: 6 months
measure: Peripheral refraction difference value-30 (D)
timeFrame: 6 months
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo Eye Hospital
state: Zhejiang
Study officials:
References: