Evaluate the Quality of Life of Patients With AMD

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Other: quality of life questionnaire

• Registration Number: NCT03242083
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-04
• Study Start: 2017-08-08
• Study First Posted: 2017-08-08
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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.

Exclusion Criteria

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
• Intraocular surgery in the 3 months preceding inclusion
• History of cornea transplantation in the studied eye
• Treatment affecting vision: chloroquine and hydroxychloroquine, phenothiazine, tamoxifen, interferon (93), external radiotherapy of the face and neck

Ophthalmological examination

• Significant cataract (LOCS III grade of 5 or above, annexe 5.) (94)
• Active infection in either eye
• Central anterior serous or active retinopathy in either eye
• Choroid neo-vascularisation
• Active serous retinal detachment
• Refractive error less than -15D or more than +10D

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Secondary atrophic AMD	quality of life questionnaire	-
Primary atrophic AMD	quality of life questionnaire	-

Primary Outcome Measures

Name	Time	Method
responses to a quality of life questionnaire	Change compared with baseline score at month 6, month 12 and month 18

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France