Informations générales (source: ClinicalTrials.gov)
Randomized Controlled Trial Evaluating the Efficacy of Venous Sinus Stenting Versus Neurosurgical Internal Ventricular Shunt on Papillary Edema in the Management of Idiopathic Intracranial Hypertension (HYDROPTIC)
Interventional
N/A
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
mars 2022
mars 2027
29 juin 2024
Idiopathic intracranial hypertension (HTICi) is a pathology, affecting young adults with
a predominance of women, due to an increase in intracranial pressure, which may be
associated with stenosis of the cerebral venous sinuses and whose origin remains unknown.
This hypertension can lead to papillary edema (OP) which can lead to a narrowing of the
visual field and progress to blindness. Along with weight reduction, acetazolamide, which
reduces the production of cerebrospinal fluid (CSF), is prescribed as a first-line
treatment. Its efficacy is inconsistent in resolving papillary edema and there are many
side effects.
In the event of ineffectiveness or dependence on acetazolamide associated with hygiene
and dietetic rules, a second line of therapy is then considered: neurosurgical (internal
shunt of the LCS) or endovascular (venous stenting) treatment.
These invasive techniques have each proven their effectiveness in the rapid and permanent
resorption of OP, allowing improvement or preservation of visual function. In terms of
induced morbidity, the superiority of one technique over the other, if it exists, has not
been established.
Our objective is to compare the efficacy, safety, and safety of LCS bypass surgery versus
venous sinus stenting in HTICi with moderate to severe visual impairment after failure of
medical treatment defined by the absence of resorption of the OP after several months
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Amélie Yavchitz | 21/06/2024 13:34:07 | Contacter | ||
Critères
Tous
Inclusion Criteria:
- Patient aged 18 or over
- HTICi proven greater than 25cm of water
- Presence of papillary edema (grade> 0 on the Frisen scale)
- Stenosis of at least one transverse sinus on MRI
- Failure of medical treatment and surgical / interventional indication defined by the
medical team taking care of the patient
- Consent to participate in the study
- Patient aged 18 or over
- HTICi proven greater than 25cm of water
- Presence of papillary edema (grade> 0 on the Frisen scale)
- Stenosis of at least one transverse sinus on MRI
- Failure of medical treatment and surgical / interventional indication defined by the
medical team taking care of the patient
- Consent to participate in the study
- Fulminant HTICi
- Contraindication to antiplatelet aggregation
- Contraindication to one or the other of the interventions under study
- Pregnant or breastfeeding woman