Department of Ophthalmology - An Sinh Hospital
Ho Chi Minh City, 700000, Vietnam
NCT Number: NCT03699423
To assess the two-week ocular responses, especially on pupillary size and accommodative amplitude, of nightly application of 0.01% or 0.02% or 0.03% atropine eye drops in children with myopia who were randomized to use of three different low-concentration atropine eye drops
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Notify Me6 year–12 year
All sexes
Interventional
Phase 1
Ho Chi Minh City, 700000, Vietnam
Atropine was proven to be effective in controlling myopia progression. However, the most common side effects of the use of atropine eye drop are dilation of pupil and decrease of accommodation. The investigators wish to evaluate the ocular responses of three low concentration atropine eye drops, 0.01% or 0.02% or 0.03%, mainly on the pupillary size and accommodative responses in children aged between 6 to 12 years old over two-week usage.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
0.01% atropine sulphate
0.02% atropine sulphate
0.03% atropine sulphate
Time frame: at baseline, at three day and at two week
Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops
Time frame: at baseline, at three day and at two week
Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops
Hai Yen Eye Care
Industry
Evaluation of Two-week Effects of 0.01%, 0.02% and 0.03% Atropine Eye Drops on Children Eyes With Myopia
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