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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)
Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study, including healthy volunteers and patients with Age-Related Macular Degeneration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with early-stage AMD | Other | 30Patients with early-stage AMD |
|
| Patients with intermediate-stage AMD | Other | 30 with intermediate-stage AMD |
|
| 30 healthy volunteers | Other | Without AMD risk |
|
| 30 healthy volunteers with central microdrusens (at risk of developing AMD) | Other | with central microdrusens (at risk of developing AMD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient-reported outcome | Other | Performance of real-life tests and tasks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validity of criteria | 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 | 26 month |
| Validity of content | number of paticipants with capacity to execute questionnaires and daily real-life task | 26 month |
| Reproducibility of results | Number of patients able to reproduce the same performance tests | 26 month |
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Inclusion Criteria:
General criteria for healthy volunteers and AMD patients:
Specific criteria for the AMD group:
General criteria for healthy volunteers:
Specific criteria for the group of healthy volunteers with central microdrusens:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabil BROUK | Contact | +33140021738 | nbrouk@15-20.fr |
| Name | Affiliation | Role |
|---|---|---|
| Michel PAQUES, Pr | centre Hospitalier Nationald'Ophtalmologie | Principal Investigator |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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Prospective, longitudinal, interventional, exploratory, non-randomised, single-centre study including healthy volunteers and patients with AMD
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| D008919 |
| Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |