Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy Clinical Trial
Official title:
The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy
| Verified date | September 2014 |
| Source | Assaf-Harofeh Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assaf Harofe Medical Center | Zerifin |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | OCT results | the reduction in retina width as recorded on OCT following 20 treatments in Hyperbaric Chamber | 1 month | No |
| Secondary | Visual Acuity | changes in visual acuity as recorded in ophthalmologic exam before and after treatments in hyperbaric chamber | 1 month | No |