2025-521878-33-00招募中2 期
Brimonidine eye drops in the prevention of myopia progression
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Myopia progression (change in spherical equivalent of refractive error) measured every 6 months
研究概览
简要总结
To determine the effect of brimonidine eye drops 0.025% on the progression of myopia in children aged 6 to 14 years. To determine the change in the refractive status of the eye 2 years after treatment.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Brimonidine eye drops in the prevention of myopia progression
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Age from ≥ 6 to ≤ 14 years.
- •Patients who, after being informed about the study design, the purposes of the study, the possible risks involved and that they may refuse to participate at any time, give their written consent to participate in the study (the patient over 12 years of age and the legal representative).
- •Myopia ≥ -1.50 Diopters of spherical equivalent, with a range of -1.50 to -5.50 D
- •Astigmatism with a cylinder power ≤ -1.50 Diopters
- •Anisometropia (difference of refraction between both eyes) in spherical equivalent ≤ 1.25 Diopters
- •Visual acuity (CVA) > 0.3 logMAR (0.5 on Snellen scale)
- •Intraocular pressure < 20 mm Hg
- •In women of childbearing age negative urine pregnancy test performed in the 7 days prior to the start of treatment
- •Women and men of childbearing age with a partner must agree to use a highly effective method of contraception (such as surgical sterilization, double barrier method, oral contraceptives or hormonal contraceptive implants) and to continue using them until 6 months after the last dose of treatment.
排除标准
- •Presence of any other ocular pathology (except myopia)
- •History of allergy to the drugs and excipients used in the study
- •History of previous therapy for myopia by means of eye drops, contact lenses or multifocal or bifocal glasses
- •Amblyopia (2 or more lines of difference in visual acuity between both eyes, on logMAR scale, with optical correction)
- •Any of the following situations present at the time: prolonged ocular hyperemia, prolonged ocular irritation, ocular infections - mucopurulent discharge in ocular tissues, ocular pain, vision changes/alterations other than myopia
- •Any clinical situation that at the investigator's discretion makes participation inadvisable
结局指标
主要结局
Myopia progression (change in spherical equivalent of refractive error) measured every 6 months
Myopia progression (change in spherical equivalent of refractive error) measured every 6 months
次要结局
- Change in axial length of the eye; axial length to corneal radius ratio (related to type of refractive error or myopia classification and risk of progression)
- Visual acuity (logMAR scale) for distance and near vision
- Stereo acuity by Randot circles / Randot preschool chart (initial visit only) in arc seconds (will be converted to logarithmic scale for statistical use of the variable).
- Pupillometry/accommodation (Power Refractor III) Pupillometry in mm, under scotopic (< 1 cd/m2), mesopic (2-3 cd/m2) and photopic (10-20 cd/m2) conditions, using Power Refractor 3
- Corneal topography with Oculus Pentacam elevation topographer.
- Accommodation (amplitude of accommodation in diopters and accommodative gain resulting from the ratio of accommodation required/accommodation achieved or realized) with Power Refractor 3
- Intraocular pressure with air tonometer (non-contact) Tonoref III (Nidek), unless it is necessary to use the applanation tonometer, in inconclusive cases; measured in mm Hg-.
- Safety: collection of adverse events
研究者
Itziar de Pablo Lopez de Abechuco
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal
研究点 (1)
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