NCT02405741

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 23, 2015

Last Update Submit

March 31, 2015

Conditions

Central Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • Optical Coherence Tomography Measurements of the Retina

    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.

    up to 40 treatments (expected average of 8 weeks)

Interventions

Hyperbaric chamber treatmentDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age 18-80 years with a documented CRVO who treated by Avastin for more than 12 months.
  • Patients who signed an informed consent form

You may not qualify if:

  • Patients with Carotid stenosis of more than 70%
  • Anemia of \< 10mg/Dl
  • Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment.
  • Patients with claustrophobia or that cannot decompress properly.
  • Patients with any malignant disease
  • Patients with inability to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofe MC

Ẕerifin, Israel

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Rubin, MD

CONTACT

972-89779720yairub@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Shai Efrati

Study Record Dates

First Submitted

March 23, 2015

First Posted

April 1, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

IL(1)