The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy

September 8, 2014 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel
        • Recruiting
        • Assaf Harofe Medical Center
        • Contact:
          • Rubinstein, MD
          • Phone Number: 0097289779358

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any diabetic patient undergoing hyperbaric chamber treatment due to diabetic ulcers

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
diabetic patients, hyperbaric chamber, diabetic retinopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCT results
Time Frame: 1 month
the reduction in retina width as recorded on OCT following 20 treatments in Hyperbaric Chamber
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 1 month
changes in visual acuity as recorded in ophthalmologic exam before and after treatments in hyperbaric chamber
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Shai Efrati, Assaf Harofe MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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