Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia
Phase: PHASE4
Conditions: Myopia
Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Efficacy and Safety of 1% Atropine 5+3 Regimen in Children and Adolescents
Controlling Myopia
2022/06/28
Shanghai Eye Diseases Prevention & Treatment Center
Department of Optometry
Research Background
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.).
Research purposes
To observe the efficacy and safety of 1% atropine ophthalmic "5+3" regimen in controlling
myopia in children and adolescents
Research content
This study was designed as a prospective, randomized controlled clinical study
Grouping
96 people in the 1% atropine 5+3 group
96 people in the 1% atropine weekly group
Children mainly from the optometry clinic of Shanghai Eye Disease Control Center
Inclusion criteria
1. Age 6 to 12 years old;
2. 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;
3. Visual function: Timus≤100 seconds, exophoria <5△, accommodation amplitude (AMP) ≥
age-related
minimum
accommodation
amplitude
value
(minimum
accommodation
amplitude=15-0.25×age);
4. No contraindications for atropine treatment such as acute eye inflammation, dry eye,
keratoconus, diabetes, etc.;
5. The written informed consent of the guardian and the child himself.
Exclusion criteria
1. History of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, fundus
macular lesions or damage;
2. Corneal curvature examination, the average K value of the anterior surface of the cornea is
≥45;
3. Patients with ocular trauma, oblique or surgical eyes, atopic keratoconjunctivitis and other
chronic eye diseases;
4. Those with previous ophthalmia, severe angular, conjunctival infection and other eye
diseases;
5. Patients with neurological diseases and allergic or contraindications to atropine or other
therapeutic drugs;
6. 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;
7. Other circumstances judged by the investigator to be unsuitable to participate in the
research.
Interventions
1.
1% atropine 5+3 group
1% atropine eye drops used 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
Total treatment time 1 year
2. 1% atropine weekly group
1% atropine eye drops once a week in both eyes
Total treatment time 1 year
Outcome

Main outcomes
Spherical equivalent and axial length before atropine treatment, and 1, 3, 6, 9, 12 months
after treatment
Secondary outcomes
safety (accommodation amplitude, amount of phoria, binocular vision function), and the
compliance and side effects (photophobia, blurred vision, etc.) before atropine treatment, and
1, 3, 6, 9, 12 months after treatment
Other outcomes
Changes in uncorrected visual acuity, corrected visual acuity, intraocular pressure, pupil
diameter, corneal thickness, anterior chamber depth, lens thickness, choroid/retina thickness,
and ciliary muscle parameters
Security indicators
1. Observe changes in intraocular pressure, headache, nausea and vomiting, etc.
2. Questionnaire survey: self-perceived photophobia, near blurred vision and other side
effects levels
3. Incidence of allergic reactions
Research methods
Sample size
Select the ciliary muscle apex thickness difference after cycloplegia for sample size
calculation
α (inspection level) = 0.05
β (test power) = 0.90
Lost to follow-up rate/dropout rate is 20%
The ratio of the two groups of samples is 1:1
The final calculated sample size is 96 (1% atropine 5+3 group) + 95 (1% atropine weekly
group) = 192 (total sample size)
grouping
Generate random numbers through a random number table, divide the random numbers
by the number of groups, and group them according to the remainder
Technical Risk

After atropine treatment, near vision blurring may occur, and there may be temporary eye
burning sensation, stinging pain, and photophobia; for people with near vision blurry, the
phenomenon affecting reading needs to be explained patiently, and the subjects should be
informed to keep correct reading distance.
1% atropine may cause dry mouth, dry skin and mucous membranes, nausea, facial
flushing, palpitations and other symptoms after systemic absorption of atropine. Stop the drug
immediately.
A small number of patients have allergic reactions such as itching, redness, and
conjunctival hyperemia of the eyelids, and the drug should be discontinued immediately.
In
case
of
increased
intraocular
pressure,
headache,
eye
pain
and
vomiting
(manifestations of acute angle-closure glaucoma). The solution is to perform initial slit-lamp
screening in all subjects before dilation, and patients with very narrow angles will not be dilated.
If the subject has symptoms such as increased intraocular pressure, headache, eye pain, etc.,
timely drug treatment.
Expected results
Prove the efficacy and safety of 1% atropine ophthalmology "5+3" program in the control
of myopia in children and adolescents.