Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)
1 other identifier
observational
70
1 country
1
Brief Summary
Monocentric and prospective study, evaluating the benefit of self-monitoring optimized by therapeutic education either by the environmental Amsler or the Amsler grid according to the patient's choice and to determine the patient's ability to determine the reality itself recidivism and therefore the need for treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2019
CompletedFirst Submitted
Initial submission to the registry
July 22, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2021
CompletedFebruary 9, 2021
February 1, 2021
2 years
July 22, 2019
February 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education.
Sensitivity and specificity of self-monitoring by the environmental Amsler or the clinical Amsler grid according to the choice of the patient after therapeutic education.
Through study completion, on average of 1 year
Eligibility Criteria
Patients with AMD who have had at least one recurrence after a shared education assessment in which they have indicated the need or desire to participate in the control of their disease and who agree to participate in a therapeutic education program at the Beau Soleil Clinic
You may qualify if:
- Affiliation to a social security scheme
- Patient agreeing to participate in the process of therapeutic education.
- Centrofoveal fixation with visual acuity\> 2/10
- Antecedent of at least one recurrence so that the patient is aware of the notion of recurrent chronic disease
- Intravitreal injection antecedent less than 6 months ago
You may not qualify if:
- Vulnerable people
- Majors subject to legal protection or unable to express their consent
- Arterial emboli disorders of less than three months such as myocardial infarction, stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinique Beau Soleil
Montpellier, 34070, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2019
First Posted
July 25, 2019
Study Start
July 10, 2019
Primary Completion
July 10, 2021
Study Completion
July 10, 2021
Last Updated
February 9, 2021
Record last verified: 2021-02