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Study on the Effect of Two Ways of Cycloplegia on Biological Parameters of Ciliary Muscle

NCT05449015 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-01-04

No results posted yet for this study

Summary

Atropine has a ciliary muscle-paralysing effect and causes hyperopic drift. Besides, atropine has been proven to slow the progression of myopia. Many studies have suggested that atropine can increase the thickness of the choroid. However, few studies have discussed changes in the ciliary muscle after treatment with atropine or other cycloplegic agents.

This study aimed to assess the difference in ciliary muscle morphology before and after two different cycloplegic agents and to analyze the correlation between the changes of ciliary muscle biological parameters and the changes of eye axis, spherical equivalent, lens diopter, choroidal thickness, etc. One hundred and forty-four children would be randomly assigned 1:1 to the 1% atropine group and the tropicamide group. This study might provide clinical evidence for the role of regulatory factors in the occurrence and development of myopia.

Conditions

  • Accomodation
  • Refractive Errors
  • Myopia
  • Cycloplegia

Interventions

DRUG

1% atropine

Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia

Sponsors & Collaborators

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Principal Investigators

  • Haidong Zou, M.D. · Shanghai Eye Diseases Prevention Treatment Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2023-03-31
Completion
2023-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05449015 on ClinicalTrials.gov