Investigator Led, Double-masked, Multicenter, Randomized Clinical Trial for the Comparison of Atropine 0.5% Versus Atropine 0.05% Eye Drops for the Prevention of Myopia Progression in Dutch Children
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 550
- 试验地点
- 40
- 主要终点
- Progression of axial length in mm from baseline to t = 36 months.
研究概览
简要总结
The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.
详细描述
With the current worldwide myopia boom the frequency of high myopia will also increase, and potentially blinding complications such as myopic macular degeneration, retinal detachment, and glaucoma will occur more often. In the Netherlands high myopia will become the most important cause of low vision and blindness by 2050. As treatment options are limited once the eye is fully grown, prevention of a long axial length at childhood is the only way to counteract this prospect. Pharmacological interventions have shown a high efficacy in stopping eye growth, in particular eye drops with high dose Atropine (0.5%, 1%). Nevertheless, the high frequency of side effects (photophobia, reading problems) of these Atropine concentrations has favoured the use of low dose Atropine. Atropine 0.01% is the most commonly used and lowest dosage; it has shown stability of refractive error, but not of axial length. Recent studies have shown that Atropine 0.05% has low risk of side effects, but a higher efficacy than 0.01%. Many ongoing trials are now comparing various low dose Atropine to placebo, but none are comparing the highest low dose to the lowest high dose Atropine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to ≤ 11 years with bilateral myopia
- •Onset of myopia ≥ 4 years of age
- •History of progression
- •SER of at least -1.00D and no greater than -6.00D in each eye measured using cycloplegic auto refraction
- •Intraocular pressure < 21 mm Hg in each eye
- •Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle of resolution) in each eye
排除标准
- •Allergy to atropine or other excipients of the eye drops
- •History of amblyopia or strabismus
- •History of retinal dystrophy or systemic disorder
- •Abnormal ocular biometry aside from axial length
- •History of glaucoma
- •Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days in 1 year).
- •Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication.
- •The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., < 2 weeks)
- •Prior myopia treatments.
- •Employees of the study center and their family members.
研究组 & 干预措施
High dose atropine
Atropine 0.5% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
干预措施: Atropine Ophthalmic 0.5% (Drug)
Low dose atropine
Atropine 0.05% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
干预措施: Atropine Ophthalmic 0.05% (Drug)
结局指标
主要结局
Progression of axial length in mm from baseline to t = 36 months.
时间窗: 3 years
次要结局
- Difference in health related quality of life(5 years)
- Progression of spherical equivalent of refraction in dioptres from baseline to t = 60(5 years)
- Proportion of subjects who progressed to high myopia (AL 26+ mm)(3 years)
- Frequency and type of treatment-related (serious) adverse events as assessed by CTCAE v5.0 (=safety)(3 years)
- Proportion of non-adherence(3 years)
- Progression of spherical equivalent of refraction in dioptres from baseline to t = 36 months. compared to atropine 0.5% treatment.(3 years)
- Progression of axial length in mm from baseline to t = 60 months.(5 years)
- Proportion of subjects who show ≤ 0.20 mm (good response); 0.2 - 0.3 mm (acceptable response), and > 3 mm (nonresponse)(3 years)
- Change in visual function (BCVA, contrast sensitivity, and glare)(3 years)
研究者
Caroline C.W. Klaver, MD
Prof. dr. C.C.W. Klaver
Erasmus Medical Center