Clinical trial NCT03035461: Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration
Official title: Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: diagnosis annoucement
patient's feelings
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 250
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of wet AMD seen in the ophtalmologic department of the CHI creteil

Brief summary: Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".

Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.

After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.

The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.


Eligibility criteria: Inclusion Criteria:

* patient up to 55 years old
* wet AMD
* diagnostic questionnaire group: patient being announced with AMD for less than 1 month
* disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months

Exclusion Criteria:

* dry AMD
* patient under 55 years old
* patient who doesn't speak French
* patient carrying an ophtalmologic genetic disorder

Primary outcomes:
measure: Description of the patient's feelings
timeFrame: up to 1 month after diagnosis
Secondary outcomes:
measure: score of general satisfaction
timeFrame: up to 1 month after diagnosis
measure: score on a comprehension quiz on AMD
timeFrame: up to 1 month after diagnosis
measure: Score on a composite score evaluating the clarity of medical explanations
timeFrame: up to 1 month after diagnosis
measure: Score on a composite score evaluating the clarity of medical explanations
timeFrame: between 6 months and 1 year of follow-up
measure: score of satisfaction of announcement conditions
timeFrame: up to 1 month after diagnosis
measure: score of satisfaction of announcement conditions
timeFrame: between 6 months and 1 year of follow-up
measure: score of satisfactions regarding the clarity of the disease course and treatment explanations
timeFrame: between 6 months and 1 year of follow-up
measure: Score on the anxiety PHQ9 questionnaire
timeFrame: between 6 months and 1 year of follow-up
measure: Score on the anxiety GAD7 questionnaire
timeFrame: between 6 months and 1 year of follow-up
Other outcomes:
Locations:
city: Créteil
country: France
facility: Marciano Joelle
state: Creteil
Study officials:
References: