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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05449015
• Other study ID #: 2022SQ006
• Status: Recruiting
• Phase: Phase 4
• Start date: December 22, 2020
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Yan Xu, M.D.
• Phone: +86 18621080996
• Email: drxuyan_2004[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

• ?Age 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; ? No contraindications to atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.; ?Written informed consent of the guardian and the child himself

Exclusion Criteria:

• ? 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; ? 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; ? Epilepsy, mental disorders unable to communicate normally; ? Other circumstances judged by the investigator to be unsuitable to participate in the research

Related Conditions & MeSH terms

• Accomodation
• Myopia
• Refractive Errors

Intervention

Drug:
• 1% atropine
Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia

Locations

Country	Name	City	State
China	Shanghai Eye Diseases Prevention & Treatment Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	choroidal thickness	choroidal thickness, microns(um), measured by SSOCT	before intervention
Other	choroidal thickness	choroidal thickness, microns(um), measured by SSOCT	immediately after the last intervention
Other	lens thickness	lens thickness(LT), millimeter(mm), measured by IOL master	before intervention
Other	lens thickness	lens thickness(LT), millimeter(mm), measured by IOL master	immediately after the last intervention
Other	lens power	lens power(LP), diopter(D), calculated by Bennett formula	before intervention
Other	lens power	lens power(LP), diopter(D), calculated by Bennett formula	immediately after the last intervention
Other	corneal parameters	central corneal thickness(CTC), micron(um), measured by IOL master	before intervention
Other	corneal parameters	central corneal thickness(CTC), micron(um), measured by IOL master	immediately after the last intervention
Other	retinal thickness	retina thickness, microns(um), measured by SSOCT	before intervention
Other	retinal thickness	retina thickness, microns(um), measured by SSOCT	immediately after the last intervention
Primary	ciliary thickness parameters	ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software	before intervention
Primary	ciliary thickness parameters	ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software	immediately after the last intervention
Primary	the distance between ciliary muscle apex and scleral spur	ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software	before intervention
Primary	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	spherical equivalent	spherical equivalent(SE),Diopter(D), measured by subjective optometry	before intervention
Secondary	spherical equivalent	spherical equivalent(SE),Diopter(D), measured by subjective optometry	immediately after the last intervention
Secondary	axial length	axial length(AL), millimeter(mm), measured by IOL master	before intervention
Secondary	axial length	axial length(AL), millimeter(mm), measured by IOL master	immediately after the last intervention