Evaluation of Two-week Effects of 0.01%, 0.02% and 0.03% Atropine Eye Drops on Children Eyes With Myopia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in pupillary diameter
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study treatments will be labelled as A, B and C by one of the team member who does not involve in the assessment and follow-up. The masked study products will then be sent to the study coordinator to dispense
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
0.01% atropine eye drops
Participants will receive one drop per eye every night for two weeks
干预措施: 0.01% atropine eye drops (Drug)
0.02% atropine eye drops
Participants will receive one drop per eye every night for two weeks
干预措施: 0.02% atropine eye drops (Drug)
0.03% atropine eye drops
Participants will receive one drop per eye every night for two weeks
干预措施: 0.03% atropine eye drops (Drug)
结局指标
主要结局
Change in pupillary diameter
时间窗: 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
Change in accommodative amplitude
时间窗: at baseline, at three day and at two week
Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops
次要结局
未报告次要终点