Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.
Launched by FONDATION OPHTALMOLOGIQUE ADOLPHE DE ROTHSCHILD · Sep 10, 2021
Trial Information
Current as of November 11, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different treatment options for a condition called idiopathic intracranial hypertension (HTICi), which often affects young women. This condition involves an increase in pressure inside the head, which can lead to swelling of the optic nerve and potentially cause vision problems or blindness. The trial aims to compare the effectiveness and safety of two surgical approaches: a procedure that creates a bypass for cerebrospinal fluid and another that involves placing a stent in the veins of the brain. These treatments are considered when the first-line medication isn’t working well enough.
To participate in this trial, you must be at least 18 years old and have been diagnosed with HTICi, showing specific signs of increased pressure. You should also have experienced problems with your vision due to this condition and have not found relief from medication. Participants can expect to receive one of the two treatments and will be monitored closely to see which option works better for improving their vision and overall safety. It's important to know that this trial is currently recruiting participants, and there are certain health conditions that may prevent someone from joining.
Gender
ALL
Eligibility criteria
- 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
- Exclusion Criteria:
- • Fulminant HTICi
- • Contraindication to antiplatelet aggregation
- • Contraindication to one or the other of the interventions under study
- • Pregnant or breastfeeding woman
About Fondation Ophtalmologique Adolphe De Rothschild
The Fondation Ophtalmologique Adolphe de Rothschild is a leading French institution dedicated to advancing ophthalmic research and patient care. Renowned for its commitment to innovation in eye health, the foundation conducts cutting-edge clinical trials aimed at improving treatments for various ocular conditions. With a multidisciplinary team of experts, the foundation collaborates with academic and industry partners to enhance understanding of eye diseases and develop novel therapeutic solutions, ultimately striving to improve patient outcomes and quality of life in ophthalmology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, France
Paris, France
Patients applied
Trial Officials
Pierre Bourdillon, MD
Principal Investigator
Fondation A. de Rothschild
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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