Study of Retinal Vascular Parameters in Patients With Wilson’s Disease

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Brief Title

Study of Retinal Vascular Parameters in Patients With Wilson's Disease

Official Title

Study of Retinal Vascular Parameters in Patients With Wilson's Disease

Brief Summary

      The rare disease reference center " Wilson disease and other rare copper-related diseases" of
      the Rothschild Foundation follows a large number of patients with Wilson's with varying
      degrees of impairment and located at different times of their care.

      Many people with Wilson's disease have a characteristic greenish-brown ring, known as
      Kayser-Fleischer, appearing at the periphery of the cornea due to a deposit of copper at the
      Descemet membrane. As a general rule, if the patient is compliant with his treatment, the
      ring usually disappears within a few years, although it may persist in some patients.
      However, apart from the stage of diagnosis, and the evolution of the ring, ophthalmological
      examinations are little used for the follow-up of these patients.

      The objective of this study is to describe the retinal parameters, in particular vascular
      with two new retinal imaging technologies (OCT-A :Optical Coherence Tomography-Angiography ,
      Adaptive optics) in patients with Wilson's disease and to correlate them with the parameters
      of the usual follow-up of these patients (hepatic assessment, exchangeable plasma copper,
      neurological scores, compliance, etc.).
    



Study Type

Interventional


Primary Outcome

Measuring the width of the Kayser-Fleischer ring


Condition

Wilson Disease

Intervention

Ophthalmological exam

Study Arms / Comparison Groups

 Ophthalmological exam
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

240

Start Date

June 4, 2020

Completion Date

June 2022

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Wilson's disease with Ferenci score ≥4

        Exclusion Criteria:

          -  Neurological or behavioral handicap that does not allow for ophthalmological
             examinations

          -  Hepatic decompensation that does not allow for ophthalmological examinations

          -  Pregnant or breastfeeding woman
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Aurélia POUJOIS, MD, (0)148036454, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04408300

Organization ID

APS_2020_5


Responsible Party

Sponsor

Study Sponsor

Fondation Ophtalmologique Adolphe de Rothschild


Study Sponsor

Aurélia POUJOIS, MD, Principal Investigator, Fondation A. de Rothschild


Verification Date

June 2020