Clinical trial NCT05448989: Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia
Official title: Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myopia
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 192
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).

Eligibility criteria: 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.

Primary outcomes:
measure: spherical equivalent
timeFrame: Before atropine treatment
measure: spherical equivalent
timeFrame: 1months after treatment
measure: spherical equivalent
timeFrame: 3months after treatment
measure: spherical equivalent
timeFrame: 6months after treatment
measure: spherical equivalent
timeFrame: 9months after treatment
measure: spherical equivalent
timeFrame: 12months after treatment
measure: axial length
timeFrame: Before atropine treatment
measure: axial length
timeFrame: 1months after treatment
measure: axial length
timeFrame: 3months after treatment
measure: axial length
timeFrame: 6months after treatment
measure: axial length
timeFrame: 9months after treatment
measure: axial length
timeFrame: 12months after treatment
Secondary outcomes:
measure: accommodation amplitude
timeFrame: Before atropine treatment
measure: accommodation amplitude
timeFrame: 1months after treatment
measure: accommodation amplitude
timeFrame: 3months after treatment
measure: accommodation amplitude
timeFrame: 6months after treatment
measure: accommodation amplitude
timeFrame: 9months after treatment
measure: accommodation amplitude
timeFrame: 12months after treatment
measure: amount of phoria
timeFrame: Before atropine treatment
measure: amount of phoria
timeFrame: 1months after treatment
measure: amount of phoria
timeFrame: 3months after treatment
measure: amount of phoria
timeFrame: 6months after treatment
measure: amount of phoria
timeFrame: 9months after treatment
measure: amount of phoria
timeFrame: 12months after treatment
measure: binocular vision function
timeFrame: Before atropine treatment
measure: binocular vision function
timeFrame: 1months after treatment
measure: binocular vision function
timeFrame: 3months after treatment
measure: binocular vision function
timeFrame: 6months after treatment
measure: binocular vision function
timeFrame: 9months after treatment
measure: binocular vision function
timeFrame: 12months after treatment
measure: photophobia
timeFrame: 1months after treatment
measure: photophobia
timeFrame: 3months after treatment
measure: photophobia
timeFrame: 6months after treatment
measure: photophobia
timeFrame: 9months after treatment
measure: photophobia
timeFrame: 12months after treatment
measure: blurred vision
timeFrame: 1months after treatment
measure: blurred vision
timeFrame: 3months after treatment
measure: blurred vision
timeFrame: 6months after treatment
measure: blurred vision
timeFrame: 9months after treatment
measure: blurred vision
timeFrame: 12months after treatment
measure: Other discomfort
timeFrame: 1months after treatment
measure: Other discomfort
timeFrame: 3months after treatment
measure: Other discomfort
timeFrame: 6months after treatment
measure: Other discomfort
timeFrame: 9months after treatment
measure: Other discomfort
timeFrame: 12months after treatment
Other outcomes:
measure: lens thickness
timeFrame: Before atropine treatment
measure: lens thickness
timeFrame: 1months after treatment
measure: lens thickness
timeFrame: 3months after treatment
measure: lens thickness
timeFrame: 6months after treatment
measure: lens thickness
timeFrame: 9months after treatment
measure: lens thickness
timeFrame: 12months after treatment
measure: lens power
timeFrame: Before atropine treatment
measure: lens power
timeFrame: 1months after treatment
measure: lens power
timeFrame: 3months after treatment
measure: lens power
timeFrame: 6months after treatment
measure: lens power
timeFrame: 9months after treatment
measure: lens power
timeFrame: 12months after treatment
measure: anterior chamber depth
timeFrame: Before atropine treatment
measure: anterior chamber depth
timeFrame: 1months after treatment
measure: anterior chamber depth
timeFrame: 3months after treatment
measure: anterior chamber depth
timeFrame: 6months after treatment
measure: anterior chamber depth
timeFrame: 9months after treatment
measure: anterior chamber depth
timeFrame: 12months after treatment
measure: corneal power
timeFrame: Before atropine treatment
measure: corneal power
timeFrame: 1months after treatment
measure: corneal power
timeFrame: 3months after treatment
measure: corneal power
timeFrame: 6months after treatment
measure: corneal power
timeFrame: 9months after treatment
measure: corneal power
timeFrame: 12months after treatment
measure: central corneal thickness
timeFrame: Before atropine treatment
measure: central corneal thickness
timeFrame: 1months after treatment
measure: central corneal thickness
timeFrame: 3months after treatment
measure: central corneal thickness
timeFrame: 6months after treatment
measure: central corneal thickness
timeFrame: 9months after treatment
measure: central corneal thickness
timeFrame: 12months after treatment
measure: retinal thickness
timeFrame: Before atropine treatment
measure: retinal thickness
timeFrame: 1months after treatment
measure: retinal thickness
timeFrame: 3months after treatment
measure: retinal thickness
timeFrame: 6months after treatment
measure: retinal thickness
timeFrame: 9months after treatment
measure: retinal thickness
timeFrame: 12months after treatment
measure: choroidal thickness
timeFrame: Before atropine treatment
measure: choroidal thickness
timeFrame: 1months after treatment
measure: choroidal thickness
timeFrame: 3months after treatment
measure: choroidal thickness
timeFrame: 6months after treatment
measure: choroidal thickness
timeFrame: 9months after treatment
measure: choroidal thickness
timeFrame: 12months after treatment
measure: ciliary muscle thickness
timeFrame: Before atropine treatment
measure: ciliary muscle thickness
timeFrame: 1months after treatment
measure: ciliary muscle thickness
timeFrame: 3months after treatment
measure: ciliary muscle thickness
timeFrame: 6months after treatment
measure: ciliary muscle thickness
timeFrame: 9months after treatment
measure: ciliary muscle thickness
timeFrame: 12months after treatment
measure: the distance between ciliary muscle apex and scleral spur
timeFrame: Before atropine treatment
measure: the distance between ciliary muscle apex and scleral spur
timeFrame: 1months after treatment
measure: the distance between ciliary muscle apex and scleral spur
timeFrame: 3months after treatment
measure: the distance between ciliary muscle apex and scleral spur
timeFrame: 6months after treatment
measure: the distance between ciliary muscle apex and scleral spur
timeFrame: 9months after treatment
measure: the distance between ciliary muscle apex and scleral spur
timeFrame: 12months after treatment
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Diseases Prevention & Treatment Center
state: Shanghai
Study officials:
affiliation: Shanghai Eye Diseases Prevention Treatment Center
name: Yan Xu, M.D.
role: STUDY_DIRECTOR
References: