Phase
Condition
Myopia
Treatment
0.05% atropine eye drops
0.01% atropine eye drops
placebo eye drops (0.1% sodium hyaluronate ophthalmic solution)
Clinical Study ID
Ages 5-14 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The age ranged from 5 to 14 years;
Astigmatism < 2.5D, spherical power: - 1.00D ~ -6.00D; difference between eyes inspherical power < 1.5D, difference between eyes in astigmatism < 1.00D;
Intraocular pressure < 21mmHg;
Ocular alignment fulfilling the following criteria:Exophoria with an exodeviation atnear > 6PD12; Intermittent exotropia with an exodeviation ≤25 PD both at distanceand at near, Titmus <=400 arc seconds; Intermittent exotropia patients underwentstrabismus surgery, 6 months after operation, fulling the criteria of exophoria andintermittent exotropia mentioned before.
Subjects and their parents or legal guardians have signed informed consent and arewilling to accept randomized grouping and regular follow-up.
Exclusion
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 controlmyopia (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, comitantesotropia;
Previous history of other ocular surgery;
Severe complications during or after strabismus surgery, such as perforation of thesclera, tear and detachment of extraocular muscle; postoperative eye movementlimitation; 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.
Study Design
Study Description
Connect with a study center
Eye and ENT Hospital, Fudan University
Shanghai,
ChinaActive - Recruiting

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