Effects of Low Concentration Atropine on Pupillary Size and Accommodative Amplitude

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of Two-week Effects of 0.01%, 0.02% and 0.03% Atropine Eye Drops on Children Eyes With Myopia

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Drug: 0.01% atropine eye drops
* Drug: 0.02% atropine eye drops
* Drug: 0.03% atropine eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read and comprehend Vietnamese and having parents or legal guardians who give informed consent as demonstrated by signing a record of informed consent. Be between 6 and 12 years old, male or female. Willing to apply eye drops once nightly at bedtime for two weeks and follow the clinical trial visit schedule as directed by the Investigator. Willing to answer the questionnaire about subjective measurements Have ocular findings deemed to be normal No contact lens wearing history Vision correctable to at least 20/25 or better in each eye with spectacles Exclusion Criteria: Any pre-existing ocular irritation, injury or condition, including infection or disease. Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial. Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. 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. History of eye surgery History of use of any myopia control interventions such as Orthokeratology, Rigid Permeable Contact Lenses Eye surgery within 12 weeks immediately prior to enrolment for this trial. Currently treated with other interventions for myopia control Contraindications to atropine such as pulmonary disease, heart conditions and ADHD Known allergy or intolerance to ingredients to atropine eye-drops and other derivatives of anti-muscarinic receptor agents. Currently enrolled in another clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.01% atropine eye drops<br>Participants will receive one drop per eye every night for two weeks | Drug: 0.01% atropine eye drops<br>* 0.01% atropine sulphate<br>|
| Active Comparator: 0.02% atropine eye drops<br>Participants will receive one drop per eye every night for two weeks | Drug: 0.02% atropine eye drops<br>* 0.02% atropine sulphate<br>|
| Active Comparator: 0.03% atropine eye drops<br>Participants will receive one drop per eye every night for two weeks | Drug: 0.03% atropine eye drops<br>* 0.03% atropine sulphate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pupillary diameter | Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops | at baseline, at three day and at two week | 
| Change in accommodative amplitude | Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops | at baseline, at three day and at two week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myopia control, low concentration atropine eye drops, anti-muscarinic receptors, pupil size, accommodative amplitude