Post-market Study for At-home Evaluation of Near Visual Acuity With OdySight, a Smartphone Based Medical Application in Comparison to a Standardized Method (TIL002)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 3
- 主要终点
- Equivalence between OdySight and standardized methods - Near Visual Acuity
研究概览
简要总结
OdySight is a mobile application allowing self-testing of visual parameters including near visual acuity and communication of the data to an online dashboard to patient's doctors. TIL-002 post-market clinical trial objective is to evaluate the near visual acuity at home, measured with OdySight application in comparison to the standardized methods. The clinical trial is intended to prove that OdySight can provide relevant data and participate in the remote monitoring of subject vision.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General inclusion criteria:
- •Age ≥ 18 years, all genders
- •Affiliated to or beneficiary of the French health care system
- •Signed/written informed consent
- •Already user of Odysight on a compatible smartphone/tablet
- •Patients willing and able to comply with all study and follow-up procedure
- •Ophthalmic inclusion criterion:
- •Baseline binocular visual acuity with habitual correction ≥ 20/63 (3/10) AND with at least an eye ≥ 20/200 (1/10).
排除标准
- •General exclusion criteria:
- •Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
- •Any planned surgery likely to modify patient refraction during the study (cataract surgery for example)
- •Subject not considered by the investigator or designee to correctly use ODYSIGHT modules
- •Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality
- •Not French speaking patient
- •Epileptic users
结局指标
主要结局
Equivalence between OdySight and standardized methods - Near Visual Acuity
时间窗: 2 months
To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT at home and standardized methods (Sloan ETDRS near vision letter chart and Landolt C near vision chart) performed in clinic.
次要结局
- Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity(2 months)