Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/​add-on Device
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Objective refractive error
研究概览
简要总结
The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device auto-refractometer with and without cycloplegia.
A single visit will be necessary.
After informed consent and checking of the inclusion and exclusion criteria, investigators will perform measurements with an auto-refractometer and with the photorefraction prototype device without cycloplegia followed by an objective refraction with an auto refractometer under cycloplegia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 6-12 years old At least 6 years old and up to 12 years old at time of informed consent and assent Average of the equivalent sphere(Sph+Cyl/2) of both eye included in the interval [-10.00, +8.00] Cylindrical refractive error between 0 and 4.00 D on both eyes Corrected binocular visual acuity in distance vision at least 6/9.
排除标准
- •Incapable of expressing consent All categories of persons particularly protected by law Subject in another study which might have an influence on vision or interfere with study assessment Less than 6 years old, or 13 years old or above at time of informed consent and assent Amblyopia, Cataract, Strabismus.
- •Aphakic or pseudophakic (intraocular implant) Reported severe eye disease involving loss of visual field as in glaucoma, involving loss of acuity and severe discomfort in low or overly bright environments as in retinitis pigmentosa or reported and treated dry eye.
- •Self-reported neurological deficits, including a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus) Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…), Any myopia control solutions that could affect refractive status of the eye (e.g. Atropine eye drops, Orthokeratology).
结局指标
主要结局
Objective refractive error
时间窗: Baseline, | 1 hour ( after intervention).
The refractive error is collected in sphere power (D), cylinder power (D) and cylinder axis (°) and converted in equivalent sphere, J0, J45 (power vector in D)
时间窗: Baseline, | 1 hour ( after intervention).
次要结局
- NA(NA)
研究者
Ramani Krishna Kumar
Sankara Nethralaya Medical Research Foundation