Hyperbaric Chamber for Central Retinal Vein Occlusion (CRVO) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT02405741
• Date of registration: 23/03/2015
• Prospective Registration: No
• Primary sponsor: Assaf-Harofeh Medical Center
• Public title: Hyperbaric Chamber for Central Retinal Vein Occlusion (CRVO) Patients
• Scientific title: Does Hyperbaric Chamber Improve the Functionality and Symptoms Related to Central Retinal Vein Occlusion (CRVO)?
• Date of first enrolment: March 2015
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02405741
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Israel

Contacts

• Name: Rubin, MD

• Name: Rubin, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients age 18-80 years with a documented CRVO who treated by Avastin for more than
12 months.

2. Patients who signed an informed consent form

Exclusion Criteria:

1. Patients with Carotid stenosis of more than 70%

2. Anemia of < 10mg/Dl

3. Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber
treatment.

4. Patients with claustrophobia or that cannot decompress properly.

5. Patients with any malignant disease

6. Patients with inability to sign informed consent

Exclusion Criteria:

-



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Central Retinal Vein Occlusion

Intervention(s)

Device: Hyperbaric chamber treatment

Primary Outcome(s)

Optical Coherence Tomography Measurements of the Retina [Time Frame: up to 40 treatments (expected average of 8 weeks)]

Secondary ID(s)

238/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors