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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors; Myopia; Accomodation; Cycloplegia
• Intervention / Treatment: Drug: 1% atropine

Detailed Description

The ciliary muscle exhibited an inward-forward contraction during accommodation, resulting in a significant thickening of the anterior area of the ciliary muscle. In addition to ultrasound biomicroscope (UBM), anterior segment optical coherence tomography (AS-OCT) is also commonly used to study morphological changes in the ciliary muscle. Studies using AS-OCT revealed that the posterior area of the ciliary muscle thinned during accommodation.

The morphology of the ciliary muscles differs in individuals with refractive errors. Many researchers found that the ciliary muscle became thicker with an increase of axial length (AL) Some studies suggested that myopia primarily affected the posterior area of the ciliary muscle.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yan Xu, M.D.; Phone Number: +86 18621080996; Email: drxuyan_2004@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Recruiting
      • Shanghai Eye Diseases Prevention & Treatment Center
      • Contact: Haidong Zou, M.D.; Phone Number: 021-62717733; Email: zouhaidong@sjtu.edu.cn
      • Principal Investigator: Yan Xu, M.D.
      • Sub-Investigator: zhaoyu xiang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ①Age 3 to 12 years old;

  • Astigmatism <2.00D, binocular anisometropia <3.00D, and the best corrected distance visual acuity is at least 0.8, near vision at least 0.8;

    • A clear anterior segment image can be obtained through anterior segment OCT;

      • Have normal thinking and language communication skills, and can actively cooperate with the inspection process; ⑤ No contraindications to atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.; ⑥Written informed consent of the guardian and the child himself

Exclusion Criteria:

• ① Combined with neurological diseases and have allergies or contraindications to cycloplegic drugs or other drugs;

  • Intraocular pressure ≥21mmHg; history of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, and retinal macular lesions or damage;

    • Patients with chronic eye diseases such as ocular trauma and allergic conjunctivitis;

      • Those who wear contact lenses and those who use myopia control-related drugs within 1 month; ⑤ Patients with previous varus trichiasis, severe horn, conjunctiva infection and other eye diseases;

        • Insufficient image quality, such as inconsistent field of view, poor image exposure, inaccurate image focus, stains, shadows or crescent shadows, etc.;

          • There are systemic diseases; ⑧ Epilepsy, mental disorders unable to communicate normally; ⑨ Other circumstances judged by the investigator to be unsuitable to participate in the research

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1% atropine; 1% atropine eye drops, in the conjunctival sac, once a night, for 7 days	Drug: 1% atropine; Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia
Placebo Comparator: tropicamide; tropicamide eye drops, in the conjunctival sac, once every 5 minutes, after 3 consecutive doses, close eyes for 20 minutes	Drug: 1% atropine; Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ciliary thickness parameters	ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software	before intervention
ciliary thickness parameters	ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software	immediately after the last intervention
the distance between ciliary muscle apex and scleral spur	ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software	before intervention
the distance between ciliary muscle apex and scleral spur	ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software	immediately after the last intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spherical equivalent	spherical equivalent(SE)，Diopter(D), measured by subjective optometry	before intervention
spherical equivalent	spherical equivalent(SE)，Diopter(D), measured by subjective optometry	immediately after the last intervention
axial length	axial length(AL), millimeter(mm), measured by IOL master	before intervention
axial length	axial length(AL), millimeter(mm), measured by IOL master	immediately after the last intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
choroidal thickness	choroidal thickness, microns(um), measured by SSOCT	before intervention
choroidal thickness	choroidal thickness, microns(um), measured by SSOCT	immediately after the last intervention
lens thickness	lens thickness(LT), millimeter(mm), measured by IOL master	before intervention
lens thickness	lens thickness(LT), millimeter(mm), measured by IOL master	immediately after the last intervention
lens power	lens power(LP), diopter(D), calculated by Bennett formula	before intervention
lens power	lens power(LP), diopter(D), calculated by Bennett formula	immediately after the last intervention
corneal parameters	central corneal thickness(CTC), micron(um), measured by IOL master	before intervention
corneal parameters	central corneal thickness(CTC), micron(um), measured by IOL master	immediately after the last intervention
retinal thickness	retina thickness, microns(um), measured by SSOCT	before intervention
retinal thickness	retina thickness, microns(um), measured by SSOCT	immediately after the last intervention

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Study Director: Haidong Zou, M.D., Shanghai Eye Diseases Prevention Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: 2022SQ006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No