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Hyperbaric Chamber for Central Retinal Vein Occlusion (CRVO) Patients

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ClinicalTrials.gov Identifier: NCT02405741
Recruitment Status : Unknown
Verified March 2015 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : April 1, 2015
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center

Brief Summary:
Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in the tissues and has been proven to be beneficial in treating different ischemic wounds, and acute retinal artery occlusion (ARAO) but its effect hasn't been tested in CRVO patients yet.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Device: Hyperbaric chamber treatment Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Hyperbaric Chamber Improve the Functionality and Symptoms Related to Central Retinal Vein Occlusion (CRVO)?
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : September 2016



Primary Outcome Measures :
  1. Optical Coherence Tomography Measurements of the Retina [ Time Frame: up to 40 treatments (expected average of 8 weeks) ]
    This is a non-contact medical imaging technology similar to ultrasound and MRI. With OCT, reflected light is used to produce detailed cross-sectional and 3D images of the eye.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405741


Contacts
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Contact: Rubin, MD 972-89779720 yairub@gmail.com

Locations
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Israel
Assaf Harofe MC Recruiting
Zerifin, Israel
Contact: Rubin, MD    972-89779720      
Sponsors and Collaborators
Assaf-Harofeh Medical Center

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Responsible Party: Assaf Harofeh MC, Dr. Shai Efrati, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02405741     History of Changes
Other Study ID Numbers: 238/14
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases