Myopia
Conditions
Brief summary
Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. 1% atropine ophthalmic drug has obvious curative effect for controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine 5+3 myopia control program and 1% atropine alternate eye myopia control program. Retrospective clinical research data showed that it could significantly reduce side effects and improve use compliance, but there is currently no evidence from prospective clinical studies.
Detailed description
Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. Among them, low-concentration atropine has few side effects and is the primary recommendation, but many clinical practices and studies suggest that its effect in controlling myopia is limited. 1% atropine ophthalmic drug has obvious curative effect advantages in controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine 5+3 myopia control (eye instillation for 5 consecutive nights in the first week of each month, one night per week in the 2nd, 3rd, and 4th weeks; after 3 months of monocular application, change to the contralateral eye), data from retrospective clinical studies have shown that it can significantly reduce side effects and improve compliance, but there is currently a lack of evidence from prospective clinical studies. Therefore, this study intends to use a randomized controlled trial, with 1% atropine used in both eyes once a week as the control group, to evaluate the effect of the 5+3 regimen in controlling myopia (spherical equivalent and axial length), safety (accommodation amplitude, amount of phoria, binocular vision function, etc.), and the compliance and side effects (photophobia, blurred vision, etc.).
Interventions
DRUG1% atropine 5+3
A method for myopia control using high-concentration atropine
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Age 6 to 12 years old; * Both eyes are in line with the diagnosis of myopic refractive error and 0.25D \< myopia spherical lens \<4.00D after mydriasis, astigmatism \<2.00D, binocular anisometropia \<3.00D, and the best corrected distance vision is at least 0.8, myopia The force is at least 0.8; * Visual function: Timus≤100 seconds, exophoria \<5△, accommodation amplitude (AMP) ≥ age-related minimum accommodation amplitude value (minimum accommodation amplitude=15-0.25×age); * No contraindications for atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.; * The written informed consent of the guardian and the child himself.
Exclusion criteria
* History of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, fundus macular lesions or damage; * Corneal curvature examination, the average K value of the anterior surface of the cornea is ≥45; * Patients with ocular trauma, oblique or surgical eyes, atopic keratoconjunctivitis and other chronic eye diseases; * Those with previous ophthalmia, severe angular, conjunctival infection and other eye diseases; * Patients with neurological diseases and allergic or contraindications to atropine or other therapeutic drugs; * Received other treatments to control the development of myopia in the past, such as the use of anticholinergic drugs such as atropine within 3 months, or participated in other relevant researchers such as functional frame mirrors and multifocal flexible mirrors; * Other circumstances judged by the investigator to be unsuitable to participate in the research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| spherical equivalent | Before atropine treatment | spherical equivalent(SE)，Diopter(D), measured by subjective optometry |
| axial length | Before atropine treatment | axial length(AL), millimeter(mm), measured by IOL master |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| binocular vision function | Before atropine treatment | measured by Titmus method, second |
| photophobia | 1months after treatment | the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire |
| accommodation amplitude | Before atropine treatment | Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D) |
| Other discomfort | 1months after treatment | Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire |
| blurred vision | 1months after treatment | the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire |
| amount of phoria | Before atropine treatment | measured by Von-Graefe method, degree(°) |
Other
| Measure | Time frame | Description |
|---|---|---|
| lens thickness | Before atropine treatment | lens thickness(LT), millimeter(mm), measured by IOL master |
| the distance between ciliary muscle apex and scleral spur | Before atropine treatment | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software |
| lens power | Before atropine treatment | lens power(LP), diopter(D), calculated by Bennett formula |
| anterior chamber depth | Before atropine treatment | anterior chamber depth(ACD), millimeter(mm), measured by IOL master |
| corneal power | Before atropine treatment | corneal power, diopter(D), measured by IOL master |
| central corneal thickness | Before atropine treatment | central corneal thickness(CTC), micron(um), measured by IOL master |
| retinal thickness | Before atropine treatment | retina thickness, microns(um), measured by SSOCT |
| choroidal thickness | Before atropine treatment | choroidal thickness, microns(um), measured by SSOCT |
| ciliary muscle thickness | Before atropine treatment | ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software |
Countries
China
Contacts
Primary ContactYan Xu, M.D.
Outcome results
None listed