The Effects of Low Dose Atropine on Choroidal Thickness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Choroidal thickness
研究概览
简要总结
Atropine eye drops are considered to be an effective form of myopia control in human eyes. However, the mechanism by which it exerts it effects are not fully understood. Thickening of the choroid subsequent to atropine administration may play an important role in the mechanisms by which atropine induces myopia control. Literature also notes that choroidal thickness undergoes diurnal variations, which is a variable that will be controlled in this study in order to examine atropine's effects on different baseline choroidal thicknesses.
The purpose of the proposed study is to characterize better the influence of atropine on choroid thickness. The study aims are to:
- Determine the effect of low dose concentration of topical atropine (0.1% and 0.01%) on choroid thickness
- Determine the effect of topical atropine on choroid thickness in relationship to baseline thickness throughout the day and after one week of daily instillation
Hypothesis: Atropine's effect on choroidal thickness will be dependent on the subject's baseline thickness measurements, at a designated time of the day when the choroid is at its thinnest.
详细描述
Atropine eye drops are an effective form of myopia control in children with progressive myopia1, but the mechanism in which this occurs is still not fully understood.
The choroid has been established to play a significant role in the modulation of ocular growth in the chick eye;2 eyes with thicker choroids grow slower than eyes with thinner choroids.3 Choroidal compensation has also been discovered in other animal species including tree shrews,4 marmosets,5 rhesus macaques,6 guinea pigs,7, 8 and even in humans.9, 10 A study in humans demonstrated how the thickening of the choroid subsequent to atropine use may contribute to the mechanisms by which atropine induces myopia control.11 These results are supported by another study where children with less choroidal thickening over time exhibited faster axial growth.12 Furthermore, diurnal variation in choroidal thickness has been documented13, 14 and individuals with thinner choroids exhibited less variation in thickness across the day. 13
Currently, atropine is prescribed by eye care providers on a daily basis and administered at night for convenience. However, choroidal thickness undergoes diurnal variations13, and the efficacy of atropine on myopia control in relationship to the patient's baseline choroidal thickness is unknown.
A preliminary study shows that atropine 1% has an effect on reducing choroidal thinning throughout the day, but how this translates to low concentration atropine as is commonly prescribed in myopia control treatment is unknown. Specifically, preliminary results reveal that the maximal pharmaceutical effects on choroidal thickening occurred one hour after atropine 1% instillation in the morning, but its relative efficacy during specific time points and duration of the day is still unclear. Also, baseline diurnal measurements demonstrate that the choroid thins in the morning, is thinnest at noon, and gradually thickens in the evening and overnight. The effects of atropine on the choroid from noon to the afternoon were not explicitly measured in our previous study, and therefore, are measurements of interest. While it is critical to understand the effects of low dose atropine on choroidal thickness throughout the evening as commonly prescribed clinically, it is important to also understand its effects when the choroid is shown to thin during the day. Additionally, the study measured changes in choroidal thickness after one instillation of atropine, but did not explore the effects of daily instillation on choroidal thickness and whether there is further minimization of choroidal thinning.
Thus, the objective of this study is to provide data to characterize the influence of low dose atropine on choroid thickness. The study aims are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and main investigator will be blinded to the allocation concealment
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 - 35 years
- •Good general and ocular health
- •Soft contact lens wearers to cease lens wear for at least 24 hours
- •No previous rigid gas permeable lens wear
- •Not taking monoamine oxidase inhibitors (MAOIs) and are not pregnant
排除标准
- •History of ocular surgery, including refractive surgery
- •Use of ocular medications
- •Amblyopia
- •Conditions where topical atropine is contraindicated
- •Any eye or systemic disease that affect vision or refractive error
研究组 & 干预措施
Atropine 0.01% then atropine 0.1%
Participants will be on topical atropine 0.01% ophthalmic solution QD OU for 1 week (7 days) and then topical atropine 0.1% ophthalmic solution QD OU for 1 week (7 days) with a washout period of 4 weeks in between each intervention
干预措施: Atropine (Drug)
Atropine 0.1% then atropine 0.01%
Participants will be on topical atropine 0.1% ophthalmic solution QD OU for 1 week (7 days) and then topical atropine 0.01% ophthalmic solution QD OU for 1 week (7 days) with a washout period of 4 weeks in between each intervention
干预措施: Atropine (Drug)
结局指标
主要结局
Choroidal thickness
时间窗: 1 hour, 4 hours, 8 hours, and 1 week from baseline measurement
Measure choroidal thickness changes at baseline and compare to choroidal thickness after intervention of atropine 0.01% and atropine 0.1%
次要结局
- Lens thickness(1 hour, 4 hours, 8 hours, and 1 week from baseline measurement)
- Axial length(1 hour, 4 hours, 8 hours, and 1 week from baseline measurement)
- Anterior chamber depth(1 hour, 4 hours, 8 hours, and 1 week from baseline measurement)
- Tear break up time (TBUT)(Baseline and 1 week from baseline measurement)
- Schirmer strip test(Baseline and 1 week from baseline measurement)
- Visual acuity(1 hour, 4 hours, 8 hours, and 1 week from baseline measurement)
- Ocular Surface Disease Index (OSDI)(Baseline and 1 week from baseline measurement)
- Quality of Vision (QoV) Questionnaire(1 hour, 4 hours, 8 hours, and 1 week from baseline measurement)
研究者
Franklin Bui
Co-principal investigator
State University of New York College of Optometry