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The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT02235935
Recruitment Status : Unknown
Verified September 2014 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : September 10, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Study Description
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Brief Summary:

Diabetic retinopathy (DR) is a common complication of diabetes and is divided into non proliferative DR and proliferative DR. The damage is caused by either macular edema, macular ischemia that can be followed by vascular proliferation.

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 wounds in diabetic patients but its effect hasn't been tested in diabetic retinopathy yet.

This study will recruit 40 diabetic patients who are scheduled for hyperbaric treatment due to different indications such as chronic wounds or radiation damages and who also have diabetic retinopathy. These patients will undergo opthalmic physical examination including fundus photography and OCT (Optical Coherence Tomography - optical IR retinal photography). Screening for these patients will be conducted at the Hyperbaric chamber at Assaf Harofe Medical Center for all diabetic patients prior to their first treatment.


Condition or disease
Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy
Study Start Date : September 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
diabetic patients, hyperbaric chamber, diabetic retinopathy


Outcome Measures
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Primary Outcome Measures :
  1. OCT results [ Time Frame: 1 month ]
    the reduction in retina width as recorded on OCT following 20 treatments in Hyperbaric Chamber


Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 1 month ]
    changes in visual acuity as recorded in ophthalmologic exam before and after treatments in hyperbaric chamber


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any diabetic patient undergoing hyperbaric chamber treatment due to diabetic ulcers
Criteria

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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Contacts and Locations
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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): NCT02235935


Locations
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Israel
Assaf Harofe Medical Center Recruiting
Zerifin, Israel
Contact: Rubinstein, MD    0097289779358      
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Shai Efrati Assaf Harofe MC
More Information
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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT02235935    
Other Study ID Numbers: 112/14
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases