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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04032808
Other study ID # 2019-A00293-54
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 10, 2019
Est. completion date July 10, 2021

Study information

Verified date February 2021
Source Clinique Beau Soleil
Contact Sandy Lacombe
Phone 0467459397
Email s.lacombe@languedoc-mutualite.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 10, 2021
Est. primary completion date July 10, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Locations

Country Name City State
France Clinique Beau Soleil Montpellier

Sponsors (1)

Lead Sponsor Collaborator
Clinique Beau Soleil

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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