A Phase 4 interventional study of 1% atropine in Accomodation, Refractive Errors and Myopia, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Status unknown at 1 site in China. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Phase 4, Interventional, and Diagnostic
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.
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.
427 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's planned enrollment of 144 is above the median of 81 across 307 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 65 studies on the registry; 30 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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;
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.;
1% atropine eye drops, in the conjunctival sac, once a night, for 7 days
Drug: 1% atropine
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
ciliary thickness parameters
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
Time frame: before intervention
ciliary thickness parameters
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
Time frame: 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
Time frame: before intervention
the distance between ciliary muscle apex and scleral spur
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time frame: immediately after the last intervention
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Time frame: before intervention
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Time frame: immediately after the last intervention
axial length
axial length(AL), millimeter(mm), measured by IOL master
Time frame: before intervention
axial length
axial length(AL), millimeter(mm), measured by IOL master
Time frame: immediately after the last intervention
choroidal thickness
choroidal thickness, microns(um), measured by SSOCT
Time frame: before intervention
choroidal thickness
choroidal thickness, microns(um), measured by SSOCT
Time frame: immediately after the last intervention
lens thickness
lens thickness(LT), millimeter(mm), measured by IOL master
Time frame: before intervention
lens thickness
lens thickness(LT), millimeter(mm), measured by IOL master
Time frame: immediately after the last intervention
lens power
lens power(LP), diopter(D), calculated by Bennett formula
Time frame: before intervention
lens power
lens power(LP), diopter(D), calculated by Bennett formula
Time frame: immediately after the last intervention
corneal parameters
central corneal thickness(CTC), micron(um), measured by IOL master
Time frame: before intervention
corneal parameters
central corneal thickness(CTC), micron(um), measured by IOL master
Time frame: immediately after the last intervention
retinal thickness
retina thickness, microns(um), measured by SSOCT
Time frame: before intervention
retinal thickness
retina thickness, microns(um), measured by SSOCT
Time frame: immediately after the last intervention
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Plan to share: No
Started Dec 2020 (actual). Primary completion is estimated for Mar 2023, 27 months after the start.
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Studies of the drug tested here: Atropine
Shanghai Eye Disease Prevention and Treatment Center