Study on the Effect of Two Ways of Cycloplegia on Biological Parameters of Ciliary Muscle
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- ciliary thickness parameters [before intervention]
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
- ciliary thickness parameters [immediately after the last intervention]
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
- the distance between ciliary muscle apex and scleral spur [before intervention]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
- the distance between ciliary muscle apex and scleral spur [immediately after the last intervention]
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Secondary Outcome Measures
- spherical equivalent [before intervention]
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
- spherical equivalent [immediately after the last intervention]
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
- axial length [before intervention]
axial length(AL), millimeter(mm), measured by IOL master
- axial length [immediately after the last intervention]
axial length(AL), millimeter(mm), measured by IOL master
Other Outcome Measures
- choroidal thickness [before intervention]
choroidal thickness, microns(um), measured by SSOCT
- choroidal thickness [immediately after the last intervention]
choroidal thickness, microns(um), measured by SSOCT
- lens thickness [before intervention]
lens thickness(LT), millimeter(mm), measured by IOL master
- lens thickness [immediately after the last intervention]
lens thickness(LT), millimeter(mm), measured by IOL master
- lens power [before intervention]
lens power(LP), diopter(D), calculated by Bennett formula
- lens power [immediately after the last intervention]
lens power(LP), diopter(D), calculated by Bennett formula
- corneal parameters [before intervention]
central corneal thickness(CTC), micron(um), measured by IOL master
- corneal parameters [immediately after the last intervention]
central corneal thickness(CTC), micron(um), measured by IOL master
- retinal thickness [before intervention]
retina thickness, microns(um), measured by SSOCT
- retinal thickness [immediately after the last intervention]
retina thickness, microns(um), measured by SSOCT
Eligibility Criteria
Criteria
Inclusion Criteria:
-
①Age 6 to 12 years old;
-
Both eyes are in line with the diagnosis of myopic refractive error and the myopia is 0.25D < myopia spherical lens <6.00D, 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;
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A clear anterior segment image can be obtained through anterior segment OCT;
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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:
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① Combined with neurological diseases and have allergies or contraindications to cycloplegic drugs or other drugs;
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Intraocular pressure ≥21mmHg; history of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, and retinal macular lesions or damage;
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Patients with chronic eye diseases such as ocular trauma and allergic conjunctivitis;
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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;
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Insufficient image quality, such as inconsistent field of view, poor image exposure, inaccurate image focus, stains, shadows or crescent shadows, etc.;
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai Eye Disease Prevention and Treatment Center
Investigators
- Study Director: Haidong Zou, M.D., Shanghai Eye Diseases Prevention Treatment Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 2022SQ006