💬In plain words
What the trial is, and whether it could suit you
Atropine is a non-selective muscarinic acetylcholine (M) receptor antagonist that paralyzes the ciliary muscle, dilates the pupil, and reduces the power of accommodation. Current studies have confirmed the effect of low concentrations of atropine drops in slowing the progression of myopia. In the atropine treatment for myopia (ATOM2) study, there was a rapid and dose-dependent decrease in accommodation after atropine drops: after 2 weeks of use, accommodation decreased from baseline 16.2D to 11.3D (4.9D) in the 0.01% atropine drops group, from baseline 16.7D to 3.8D (12.9D) in the 0.1% atropine group, and from baseline 15.8 D to 2.2 D (13.6 D) in the 0.5% atropine group; one year after withdrawal, there was some recovery of the accommodation in all the three groups, but it was still lower than the baseline values for each group, with a mean decrease of 2.56 D.Similar results were found i
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* The age ranged from 5 to 14 years;
* Astigmatism \< 2.5D, spherical power: - 1.00D \~ -6.00D; difference between eyes in spherical power \< 1.5D, difference between eyes in astigmatism \< 1.00D;
* Intraocular pressure \< 21mmHg;
* Ocular alignment fulfilling the following criteria：Exophoria with an exodeviation at near \> 6PD12; Intermittent exotropia with an exodeviation ≤25 PD both at distance and at near, Titmus \<=400 arc seconds; Intermittent exotropia patients underwent strabismus surgery, 6 months after operation, fulling the criteria of exophoria and intermittent exotropia mentioned before.
* Subjects and their parents or legal guardians have signed informed consent and are willing to accept randomized grouping and regular follow-up.
Exclusion Criteria:
* Amblyopia
* Have heart disease or serious respiratory disease
* Allergic to atropine, cyclopentantone, propoxybenzocaine and benzalkonium chloride;
* Those who have used contact lenses, bifocal lenses, or other measures to control myopia (including atropine);
* No binocular vision;
* Combined with vertical strabismus≥5PD, abnormal oblique muscle function≥ 2+, cyclodeviation, DVD or A-V pattern, paralytic and restrictive strabismus, comitant esotropia；
* Previous history of other ocular surgery;
* Severe complications during or after strabismus surgery, such as perforation of the sclera, tear and detachment of extraocular muscle; postoperative eye movement limitation; visual acuity decreased after operation;
* Combined with other ocular diseases;
* Craniofacial malformations affecting the orbits;
* significant neurological disorders;
* Birth less than 34 weeks or birth weight less than 1500 g;
* Intraocular pressure \> 21mmhg;
* Unable to cooperate with the examination.
💊
What it tests
- 0.01% atropine eye drops
- placebo eye drops (0.1% sodium hyaluronate ophthalmic solution)
- 0.05% atropine eye drops
Eye and ENT Hospital, Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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