Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical Application in Comparison to a Standardized Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Near visual acuity assessment with OdySight versus with near visual acuity chart
研究概览
简要总结
This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age ≥ 18 years
- •Able to correctly distinguish the body laterality (left and right)
- •Able to recognize alphabet letters and read French
- •Affiliated to or beneficiary of the French health care system
- •Signed/written informed consent
- •Subject presenting a level of visual acuity of one of his eyes that fits to one of the pre-set cohort (visual acuity between +1.0 and +0.7 logMAR, between +0.6 and +0.3 logMAR or between +0.2 and 0.0 logMAR); the two eyes can be included in two different cohorts.
排除标准
- •Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
- •Pregnant and breastfeeding women.
- •Subject not considered by the investigator or designee to correctly use OdySight modules after the training session
研究组 & 干预措施
Near visual acuity +1.0 and +0.7 logMAR
Subjects with near visual acuity between +1.0 and +0.7 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application
干预措施: Standards vision tests (Other)
Near visual acuity +1.0 and +0.7 logMAR
Subjects with near visual acuity between +1.0 and +0.7 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application
干预措施: OdySight medical application assessment (Device)
Near visual acuity +0.6 and +0.3 logMAR
Subjects with near visual acuity between +0.6 and +0.3 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application
干预措施: Standards vision tests (Other)
Near visual acuity +0.6 and +0.3 logMAR
Subjects with near visual acuity between +0.6 and +0.3 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application
干预措施: OdySight medical application assessment (Device)
Near visual acuity +0.2 and +0.0 logMAR
Subjects with near visual acuity between +0.2 and +0.0 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application
干预措施: Standards vision tests (Other)
Near visual acuity +0.2 and +0.0 logMAR
Subjects with near visual acuity between +0.2 and +0.0 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application
干预措施: OdySight medical application assessment (Device)
结局指标
主要结局
Near visual acuity assessment with OdySight versus with near visual acuity chart
时间窗: 1 day ( During evaluation visit)
To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT (NVA module) and a standardized method (Sloan ETDRS near vision letter chart).
次要结局
- Near visual acuity assessment with OdySight versus with ETDRS chart(1 day ( During evaluation visit))