The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy

• Conditions: Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy

• Registration Number: NCT02235935
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-08
• Last Update Submitted: 2014-09-08
• Study First Posted: 2014-09-10
• Last Update Posted: 2014-09-10
• Primary Completion: 2015-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OCT results	1 month	the reduction in retina width as recorded on OCT following 20 treatments in Hyperbaric Chamber

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	1 month	changes in visual acuity as recorded in ophthalmologic exam before and after treatments in hyperbaric chamber

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Zerifin, Israel