Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
28 participants
OBSERVATIONAL
2017-08-08
2019-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary atrophic AMD
quality of life questionnaire
quality of life questionnaire
Secondary atrophic AMD
quality of life questionnaire
quality of life questionnaire
Interventions
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quality of life questionnaire
quality of life questionnaire
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon Bourgogne
Dijon, , France
Countries
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Other Identifiers
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KAUFFMANN PCA 2016
Identifier Type: -
Identifier Source: org_study_id
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