EUCTR2020-002046-16-CZ进行中（未招募）1 期
A Randomised, double-blinded, placebo-controlled, multicenter study of efficacy, safety and side effects of highly diluted atropine collyrium in slowing the progression of myopia (shortsightedness) in children - M.A.R.S.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 237
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Age 6-12 years
- •2) Diagnosis of myopia - spherical component of refraction -0.5 Dsf to -4.75 Dsf and astigmatism 0 to -2.5 Dcyl at least on one of the eyes
- •3) BCDVA of worse eye better or equal to 0.2 logMAR (according to ETDRS test, 85 cd / m2)
- •4) Corneal topography index (anterior corneal area): KI < 1,07, ISV < 37 at least on one of the eyes
- •5) Normal ocular finding and history in both eyes (except for spectacle correction and banal eye diseases, eg history of acute conjunctivitis, lacrimal lavage in early childhood)
- •6) Normal binocular functions in both eyes (in sensory and motor components) with the exception of exophoria equal to or more than 8 Dp incl. in an alternating covering test with prisms
- •7) Normal intraocular pressure (= 22 torr, contactless applanation) in both eyes
- •8) Fulfillment of the indication criterion of AXL growth in 6-8M in 9M observation period before enrollment to the study according to the data in the patient medical documentation in at least on one of the eyes:
- •Age AXL growth in 6M AXL growth in 7M AXL growth in 8M
- •6-7 years, 0.10 mm 0.11 mm 0.12 mm
- •8-9 years, 0.11 mm 0.12 mm 0.13 mm
- •10-11 years, 0.12 mm 0.13 mm 0.14 mm
- •9) The willingness of the patient and his / her parents / legal guardian to undergo a two-year period of daily application of eye drops, a three-year period of clinical examinations every six months and weekly keeping of diary entries during this period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 237
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) General diseases, that can lead to myopia (Marfan's, Stickler's syndrome) or affect visual functions (diabetes mellitus, chromosomal anomalies)
- •2) Previous pharmacological, surgical and/or orthokeratological therapy of myopia
- •3) Previous long-term treatment with atropine (e.g. longer than 14 days)
- •4) Presence and/or history of allergic reaction to ophthalmologics (atropine; cycloplegics - cyclopentolate, tropicamide; local anesthetics - eg oxybuprocaine, etc.)
- •5) Presence of strabism, amblyopia, glaucoma, corneal damage and/or corneal scarring and current and/or previous ocular conservative, contactology and/or surgical therapy
- •6) Presence and/or history of general disease (incl. allergy, myasthenia gravis, cardiac, respiratory and/or renal-urological disease and/or dysfunction)
- •7) Presence or scheduled launch of long-term (i.e. longer than 14 days) general and/or local drug therapy and/or scheduled surgical therapy for the participation in the study
- •8) Concomitant use of monoamine oxidase inhibitors (MAOIs)
- •9) Pregnancy, ev. breast feeding
- •10) Presence of rhinitis sicca
研究者
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