Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration

NCT03035461 | Completed

• 1 other identifier: PANDA
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Macular Degeneration

Keywords

diagnosis annoucement; patient's feelings

Outcome Measures

Primary Outcomes (1)

• Description of the patient's feelings

  A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis. they can also explain their feelings by themselves.

  up to 1 month after diagnosis

Secondary Outcomes (9)

• score of general satisfaction

  up to 1 month after diagnosis

• score on a comprehension quiz on AMD

  up to 1 month after diagnosis

• Score on a composite score evaluating the clarity of medical explanations

  up to 1 month after diagnosis

• Score on a composite score evaluating the clarity of medical explanations

  between 6 months and 1 year of follow-up

• score of satisfaction of announcement conditions

  up to 1 month after diagnosis

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of wet AMD seen in the ophtalmologic department of the CHI creteil

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Marciano Joelle

Créteil, Creteil, 94000, France

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthoptist in the ophtalmologic department of the CHI Creteil

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 30, 2017
• Study Start: March 15, 2017
• Primary Completion: February 1, 2018
• Study Completion: October 19, 2018
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)