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Completed

NCT Number: NCT06758843

Comparing Relative Peripheral Refraction on Myopia Progression

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ningbo Eye Hospital

Ningbo, Zhejiang, 315000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Total value of relative peripheral refraction from MRT (D)

    Time frame: 12 months

    The parameter obtained using MRT for analysis is = total peripheral refraction - central refractive error.

  2. Total relative peripheral refraction from MRT (D)

    Time frame: 6 months

    The parameter obtained using MRT for analysis

    • total peripheral refraction error - central refractive error

Secondary outcomes

  1. Superior peripheral myopic defocus (D)

    Time frame: 12 months

    which indicates the average peripheral refractive error from the center to the peripheral of superior area of the retina.

  2. peripheral refraction difference value 15 degree (D)

    Time frame: 12 months

    which indicates the average paracentral refractive error from the center to 15◦ of the retina

  3. Peripheral refraction difference value-30 (D)

    Time frame: 12 months

    which indicate the average peripheral refractive error at 30 ◦

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

    Time frame: 12 months

    the relative refraction difference value- 45which indicate the average peripheral refractive error at 45◦ of the posterior retina measured by MRT

  5. relative refraction difference value-inferior (D）

    Time frame: 12 months

    the relative refraction difference value of inferior, which is measured by MRT

  6. relative refraction difference value-nasal (D)

    Time frame: 12 months

    the relative refraction difference value-nasal measured by MRT

  7. relative refraction difference value-temporal (D).

    Time frame: 12 months

    the relative refraction difference value-temporal measured by MRT.

  8. Change of refractive error (D)

    Time frame: 12 months

    the change of refractive error is measured by auto-refractor without cycloplegia

  9. Visual acuity (decimal )

    Time frame: 12 months

    the visual acuity is test with decimal visual acuity chart at distance

  10. Visual acuity (decimal )

    Time frame: 6 months

    the visual acuity is test with decimal visual acuity chart at distance

  11. Superior peripheral myopic defocus (D)

    Time frame: 6 months

    which indicates the average peripheral refractive error from the center to the peripheral of superior area of the retina.

  12. peripheral refraction difference value 15 degree (D)

    Time frame: 6 months

    which indicates the average paracentral refractive error from the center to 15◦ of the retina

  13. Change of refractive error (D)

    Time frame: 6 months

    the change of refractive error is measured by auto-refractor without cycloplegia

  14. relative refraction difference value-inferior (D）

    Time frame: 6 months

    the relative refraction difference value of inferior, which is measured by MRT

  15. relative refraction difference value-nasal (D)

    Time frame: 6 months

    the relative refraction difference value-nasal measured by MRT

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

    Time frame: 6 months

    the relative refraction difference value- 45which indicate the average peripheral refractive error at 45◦ of the posterior retina measured by MRT

  17. Peripheral refraction difference value-30 (D)

    Time frame: 6 months

    which indicate the average peripheral refractive error at 30 ◦

Sponsors and collaborators

Lead sponsor

Fuzhou Southeast Institute of Visual Ophthalmology

Other

Registry information

Official study title

A Prospective, Controlled, Parallel Trial of Comparing Relative Peripheral Refraction Between Parameters Before and After Myopia Progression with Multispectral Refraction Topography

Acronym: CMPMRT

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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