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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02235935 |
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Date of registration:
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08/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy
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Scientific title:
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The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02235935 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Rubinstein, MD |
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Address:
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Telephone:
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0097289779358 |
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Email:
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Affiliation:
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Name:
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Shai Efrati |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assaf Harofe MC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Inclusion criteria:
1. Patients between ages 18-90 with Diabetes type I or II and diabetic retinopathy who
are scheduled for hyperbaric treatment for other indications than DR.
2. Patients who signed an informed consent form and agree to undergo an ophthalmic
physical examination, Fundus photography and OCT prior to hyperbaric treatment and
oCT exam following every 10 treatments in hyperbaric chamber. Total number of
hyperbaric treatments will be conducted according to the main indication for which
they have been assigned this treatment.
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
Decompression treatment will last 90 minutes in 2 atmospheres pressure with 100% oxygen.
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Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy
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Primary Outcome(s)
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OCT results
[Time Frame: 1 month]
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Secondary Outcome(s)
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Visual Acuity
[Time Frame: 1 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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