Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-02 @ 7:22 PM
Study NCT ID:
NCT02235935
Status:
UNKNOWN
Last Update Posted:
2014-09-10
First Post:
2014-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Study Overview
Official Title:
The Effect of Hyperbaric Chamber Treatment on Patients With Diabetic Retinopathy
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: