Development of a New Device and Method for Determining Refractive Errors in a Myopic Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Difference of Optical Values
研究概览
简要总结
The purpose of this clinical investigation is to check whether the new device can correctly measure a person's degree of myopia and astigmatism.
To evaluate and improve the device's performance, the results (optical correction values and the associated visual acuity) obtained with the investigational device will be compared with the results obtained using standard instruments commonly used by eye care professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
- •Aged between 18 and 39 years at the time of study inclusion
- •Wear corrective glasses
- •With an ophthalmologist's prescription for corrective eyewear less than 3 years old
- •Spherical error of each meridian within the range of [-5.00 ; -0.50 D]
- •Cylindrical defect included in interval [-4.50 ; 0.00 D]
- •Corrected monocular visual acuity ≤ 0.0 logMAR for distance vision (≥10/10)
- •French Social Security beneficiary
排除标准
- •General criteria for non-inclusion:
- •Essilor International employee
- •Pregnant, or breast-feeding women (Article L1121-5)
- •Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research
- •Adults incapable or unable to express consent (Article L1121-8)
- •Participant included in another ongoing study or in a period of exclusion
- •All categories of persons particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the French Public Health Code)
- •Amblyopia, strabismus, nystagmus
- •Wearing progressive lenses
- •The following elements are considered based on the participant's declaration :
- •Declared cataract, Aphakia (without lens) or pseudophakia (with intraocular implant)
- •Ocular surgery (iridectomy, refractive surgery, corneal transplant)
- •Ocular trauma (corneal deformation, contusion, chemical burn, foreign body intrusion, perforation, orbital fracture, enucleation)
- •Severe ocular pathology, involving loss of visual field as in glaucoma or retinitis pigmentosa, involving loss of acuity and severe discomfort in dimly or brightly lit environments as in Age related macular degeneration (AMD) or overt and treated dry eye.
- •Systemic pathology affecting vision (diabetes, uncontrolled blood pressure, myasthenia gravis, etc.).
- •Medication that may affect vision or interfere with study measures (antidepressants, medication with atropine-like effects).
- •Declared neurological deficits, in particular a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g. balance disorders).
结局指标
主要结局
Difference of Optical Values
时间窗: Day One
Optical correction values obtained with the investigational device are compared with the values obtained using a phoropter (gold standard method - subjective refraction)
Difference in the proportion of visual acuity levels
时间窗: Day One
Comparison of the proportion of participants reaching specific monocular visual acuity levels (≥10/10 and ≥12/10) when wearing the refraction obtained from the investigational device versus the subjective refraction obtained from a phoropter (gold standard method)
次要结局
- Comparison of Monocular Visual Acuity Distribution(Day One)