Actively Recruiting
CHOPXE - Analysis of Choriocapillaris Flow Deficits in Patients With Pseudoxanthoma Elasticum
Led by University Hospital, Angers · Updated on 2025-12-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pseudoxanthoma elasticum (PXE), a rare genetic disease that causes excessive tissue mineralization leading to skin, vascular, and eye problems, including vision loss. This study aims to compare blood flow deficits in the choriocapillaris, a layer in the eye important for retinal health, between healthy individuals and PXE patients. The goal is to find early changes in eye structures that could help track the disease progression and support evaluation of future treatments. The study uses a non-invasive eye imaging technique called optical coherence tomography angiography (OCT-A) to measure choriocapillaris flow deficits. Participants include healthy volunteers and PXE patients in early disease stages. During a scheduled ophthalmology visit, participants undergo eye exams including visual acuity testing, slit lamp exam, fundus photography, and OCT-A scans. Additional patient history and genetic information are collected for PXE patients. The study plans to include 60 healthy controls and 60 PXE patients. Participants provide personal and medical history information and undergo detailed eye assessments to rule out other eye diseases. Imaging data from OCT-A scans are analyzed to measure blood flow deficits in a single selected eye. Researchers will compare these findings between groups and explore links to factors like skin inflammation and vascular issues. The study will continue until late 2026, with data collection occurring during the inclusion visit. Safety and image quality are closely monitored throughout.
CONDITIONS
Brief Title
CHOPXE - Analysis of Choriocapillaris Flow Deficits in Patients With Pseudoxanthoma Elasticum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant not afflicted by the disease under investigation and without ophthalmological pathology
- Person matched in age (+/- 5 years) and gender to a PXE patient in pre-atrophic stages
- Signed informed consent for participation
- Adult at time of inclusion
- Patient diagnosed with pseudoxanthoma elasticum by Plomp's criteria
- Included in the PXE cohort
- Pre-atrophic damage: at least one eye without choroidal neovessels on OCT-A, no prior anti-VEGF injection, and limited retinal atrophy
- Usable angiographic OCT results (no artifacts, image quality ≥ 50/100)
- Patient's agreement to participate in the study
You will not qualify if you...
- Known ophthalmological diseases (maculopathy, glaucoma, optic neuropathy, retinopathy of any cause)
- Severe myopia (sphere worse than -6 diopters)
- Diabetes
- Unable to complete ophthalmological exams
- Pregnant, breastfeeding, or recently given birth
- Under psychiatric care under constraint
- Subject to legal protection measures
- Not affiliated with or benefiting from social security
- Ophthalmic pathology discovered during workup
- Unusable AngioOCT examination (poor image quality or artifacts)
- Other known ophthalmological pathology in PXE patients
- Diabetic subjects in PXE group
- Severe myopia discovered during workup in PXE patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit during inclusion
Participants undergo ophthalmologic diagnostic tests including measurement of visual acuity, slit-lamp examination, fundus examination, and optical coherence tomography angiography (OCT-A) to assess choriocapillaris flow deficits.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Angers University Hospital
Angers, France, 49000
Actively Recruiting
Research Team
L
Laurie MOUROZEAU, Doctor
M
Matthieu LE LAY, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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