Validation of Standardized Tasks and Questionnaires to Evaluate and Understand the Impact of Age-related Macular Degeneration on Daily Living Activitie
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Validity of criteria
研究概览
简要总结
The complex and variable course of age-related diseases makes it all the more necessary to carry out personalised, reasoning-based examinations to improve the personalised assessment and management of AMD. However, functional assessment of AMD is most often based solely on visual acuity, and classifications of AMD are based solely on structural markers. There is therefore a need to improve the detection and functional assessment of this vision-threatening eye disease, by complementing and extending the standard assessments of clinical outcomes (COA)
详细描述
Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study, including healthy volunteers and patients with Age-Related Macular Degeneration
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General criteria for healthy volunteers and AMD patients:
- •Male / Female participant,
- •Age ≥ 50 at inclusion,
- •Able and willing to provide written informed consent and comply with the study protocol, visits and assessments,
- •Quality of AO imaging as assessed by rtx1 camera, ● deemed adequate according to the study physician,
- •Membership of a social security scheme or beneficiary of such a scheme.
- •Specific criteria for the AMD group:
- •Geriatric Depression Scale (GDS) questionnaire score ≤ 10 A COGEVIS questionnaire score ≥ 24/30
- •Visual acuity greater than 4/10ths
- •General criteria for healthy volunteers:
- •No detectable visual pathologies
- •Best monocular visual acuity (corrected to 100% of the contrast) ≥ 8/10ths before age 70 and ≥ 6/10ths after.
- •MMSE score ≥ 20
- •Specific criteria for the group of healthy volunteers with central microdrusens:
- •No detectable visual pathologies other than the presence of central microdrusens.
- •Best monocular visual acuity (corrected to 100% contrast) ≥ 8/10th before age 70 and ≥ 6/10th after.
- •MMSE score ≥ 20
排除标准
- •Pregnant, parturient or breast-feeding women,
- •Subjects taking medication likely to cause motor, visual, vestibular or cognitive disorders (PSA, neuroleptics, etc.) or who could interfere with the study examinations cannot be included in this study,
- •Environmental opacity or eye movement disorders (nystagmus) which, in the opinion of the investigator, interfere with the quality of retinal imaging data.
- •Any concomitant intraocular condition in the study eye (e.g. glaucoma or cataract) that, in the opinion of the investigator, would require surgical intervention during the study to prevent or treat vision loss that may result from this condition or affect the interpretation of study results,
- •Known systemic disease which, in the opinion of the investigator, would preclude active participation in the study,
- •Participation in any other therapeutic study evaluating a drug,
- •Cognitively impaired subjects, illiterate subjects and subjects who do not speak the national language.
- •Subjects with dyslexic reading disorders,
- •Subjects subject to a reinforced protection measure or legal safeguard (curatorship, guardianship).
研究组 & 干预措施
30 healthy volunteers with central microdrusens (at risk of developing AMD)
with central microdrusens (at risk of developing AMD)
干预措施: patient-reported outcome (Other)
Patients with intermediate-stage AMD
30 with intermediate-stage AMD
干预措施: patient-reported outcome (Other)
30 healthy volunteers
Without AMD risk
干预措施: patient-reported outcome (Other)
Patients with early-stage AMD
30Patients with early-stage AMD
干预措施: patient-reported outcome (Other)
结局指标
主要结局
Validity of criteria
时间窗: 26 month
Number of patients with capacity of discrimintaion compared to healthy volunteers. ROC (receiver operating characteristic curve), which illustrates the diagnostic capacity of a binary classification system as a function of the variation in its discrimination threshold. The ROC curve is created by plotting the rate of true positives versus the false-positive rate for different thresholds. The index used to characterize a test's of a test is the air under the curve
Reproducibility of results
时间窗: 26 month
Number of patients able to reproduce the same performance tests
Validity of content
时间窗: 26 month
number of paticipants with capacity to execute questionnaires and daily real-life task
次要结局
未报告次要终点