Evaluation of the Performance of Self-monitoring Optimized by Therapeutic Education in the Recurrence of Wet Age-related Macular Degeneration (AMD)

February 8, 2021 updated by: Clinique Beau Soleil
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France, 34070
        • Recruiting
        • Clinique Beau Soleil
        • Contact:
        • Sub-Investigator:
          • Sophie Navarre, Dr
        • Sub-Investigator:
          • Charlotte Rohart, Dr
        • Principal Investigator:
          • Allieu Sandrine, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion, on average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Beau Soleil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2019

Primary Completion (Anticipated)

July 10, 2021

Study Completion (Anticipated)

July 10, 2021

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A00293-54

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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