Evaluate the Quality of Life of Patients With AMD

NCT03242083 | Completed

• 1 other identifier: KAUFFMANN PCA 2016
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems that can impair their quality of life in the physical, mental and social domains. The principal objective principal of this study is to describe the evolution of quality of life between the diagnosis of secondary atrophic AMD and at 18 months after confirmation of diagnosis.

Conditions

Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• responses to a quality of life questionnaire

  Change compared with baseline score at month 6, month 12 and month 18

Study Arms (2)

Primary atrophic AMD

Other: quality of life questionnaire

Secondary atrophic AMD

Other: quality of life questionnaire

Interventions

quality of life questionnaire OTHER

quality of life questionnaire

Primary atrophic AMD; Secondary atrophic AMD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

During an ophthalmology consultation, the clinician who has established the diagnosis of primary atrophic or secondarily atrophic AMD (defined in 1.1.2) proposes to the patient fulfilling the aforementioned eligibility criteria to participate in the study.

You may qualify if:

• \- For the 2 populations studied
• Persons who have given consent to take part
• Persons aged 50 years or older
• Willing and able to attend all of the scheduled visits and evaluations
• Macular atrophy or drusen measuring at least 125μm or multiple drusens measuring at least 63μm
• Atrophic AMD diagnosed on OCT and by autofluorescence and OCT angiography by 2 independent experienced assessors
• Diagnosed for less than 3 years
• MAVC score ≥ 19 letters (Equivalent Snellen ≥ 20/400), by using a scale at an initial distance of 4m
• For patients with secondary atrophic AMD
• Secondary atrophic AMD, defined by persistent atrophic AMD at 1 year after the last injection of an anti-angiogenic agent, and at least 2 years after the first injection.

You may not qualify if:

• General criteria
• Persons without national health insurance cover
• Physical or mental disability ruling out participation
• Inability to sign the written consent form, adults under guardianship
• Any participation in a study involving an experimental drug during the previous 3 months (dietary supplements are authorised).
• Adults under guardianship
• General medical history
• Uncontrolled AHT
• Ophthalmological history
• Severe non-proliferative or proliferative diabetic retinopathy
• Uncontrolled glaucoma (defined as an intra-ocular pressure greater than 30mmHg despite treatment with an anti-glaucoma agent) or a history of filtration surgery
• Corneal disease that could impair vision
• Monogenic macular dystrophy or toxic maculopathy
• History of uveitis
• Amblyopia of the eye concerned

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, 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: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 8, 2017
• Study Start: August 8, 2017
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

FR (1)