Status:
RECRUITING
CHOPXE - Analysis of Choriocapillaris Flow Deficits in Patients With Pseudoxanthoma Elasticum
Lead Sponsor:
University Hospital, Angers
Conditions:
Pseudoxanthoma Elasticum
Tomography, Optical Coherence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This observational study sets out to compare choriocapillaris flow deficits between healthy control subjects and patients with pseudoxanthoma elasticum. Pseudoxanthoma elasticum (PXE) is a rare, incur...
Detailed Description
CHOPXE is a single-center, cas-control, cross-sectional study with the objective of comparing choriocapillaris flow deficits by OCT angiography (OCT-A) between healthy control subjects and patients wi...
Eligibility Criteria
Inclusion Criteria:
- Participant not afflicted by the disease under investigation and without ophthalmological pathology
- Person matched in age (+/- 5 years) and gender to a case (patient with PXE in pre-atrophic stages included in the PXE cohort)
- Signature of informed consent for participation in the protocol
- Adult at time of inclusion Criteria for non-inclusion of research subjects
- Known ophthalmological diseases (maculopathy, glaucoma, optic neuropathy, retinopathy whatever the aetiology)
- Known severe myopia, defined by a sphere > - 6 dioptres
- Diabetic subject
- Unable to carry out the ophthalmological examinations of the study
- Pregnant, breast-feeding or parturient woman
- Person undergoing psychiatric care under constraint
- Person subject to a legal protection measure
- Person not affiliated or not benefiting from a social security scheme
Exclusion Criteria:
- Ophthalmic pathology (maculopathy, glaucoma, optic neuropathy, retinopathy, whatever the etiology) discovered during the ophthalmic workup
- AngioOCT examination inexploitable (artifact and/or image quality less than 50/100 even after pupillary dilation)
- Severe myopia (sphere > - 6 dioptres) discovered during the ophthalmic workup.
Case inclusion critera :
- Patient diagnosed with pseudoxanthoma elasticum, defined according to Plomp's criteria: two out of three features related to PXE: (1) two pathogenic mutations in the ABCC6 gene, and/or (2) disease-specific dermatological changes and/or (3) disease-specific ocular changes;
- Included in the PXE cohort ;
- With pre-atrophic damage, i.e. at least one eye without choroidal neovessels on OCT-A, without previous intravitreal injection of anti-VEGF, and without major retinal atrophy (less than 2 papillary diameters);
- who have had an angiographic OCT (performed during follow-up consultations) with usable results (no artifacts and image quality of 50/100 or better) ;
- patient's non-objection to participation in a study
Case criteria for non-inclusion :
- Other known ophthalmological pathology (maculopathy, glaucoma, optic neuropathy, retinopathy of any etiology)
- Severe myopia, defined by a sphere > - 6 dioptres
- Diabetic subject
Key Trial Info
Start Date :
November 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07006649
Start Date
November 28 2025
End Date
November 1 2026
Last Update
December 8 2025
Active Locations (1)
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1
Angers University Hospital
Angers, France, 49000