Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04648618
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2020-11-23
Brief Title:
Obstructive Sleep Apnea and Diabetic Macular Edema Inflammatory Mediators
Sponsor:
Uptown Eye Specialists
Organization:
Uptown Eye Specialists
Study Overview
Official Title:
Impact of Obstructive Sleep Apnea on the Expression of Inflammatory Mediators in Diabetic Macular Edema
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ACTIVE_NOT_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:
Obstructive sleep apnea OSA is characterized by intermittent nocturnal hypoxemia frequent arousals fragmented sleep and daytime sleepiness It has been shown to increase the risk of cardiac and vascular disease through multiple mechanisms including sympathetic hyperactivity metabolic dysregulation and activation of oxidative stress and inflammatory pathways
Diabetic retinopathy is a leading cause of blindness in the working age group affecting 93 million people worldwide Diabetic macular edema DME is a sight threatening complication and the most common cause of visual loss in patients with diabetes OSA is frequently associated with diabetes with prevalence ranging from 23 to 86 However the relationship between OSA and DME is not well defined The retina is especially susceptible to hypoxia being one of the most metabolically active tissues Many of the same inflammatory mediators have also been found to be elevated in patients with diabetic macular edema including VEGF VCAM-1 and IL-6
There has been no previous study examining the biochemical impact of OSA on patients with DME We aim to explore this relationship by examining the differences in inflammatory markers expressed in patients with DME who have undergone an overnight sleep study which is considered the gold standard diagnostic tool in OSA
Diabetic retinopathy is a leading cause of blindness in the working age group affecting 93 million people worldwide Diabetic macular edema DME is a sight threatening complication and the most common cause of visual loss in patients with diabetes OSA is frequently associated with diabetes with prevalence ranging from 23 to 86 However the relationship between OSA and DME is not well defined The retina is especially susceptible to hypoxia being one of the most metabolically active tissues Many of the same inflammatory mediators have also been found to be elevated in patients with diabetic macular edema including VEGF VCAM-1 and IL-6
There has been no previous study examining the biochemical impact of OSA on patients with DME We aim to explore this relationship by examining the differences in inflammatory markers expressed in patients with DME who have undergone an overnight sleep study which is considered the gold standard diagnostic tool in OSA
Detailed Description:
The purpose of this study is to compare the levels of inflammatory mediators in diabetic patients with macular edema with and without OSA
This will be a single centre prospective cross-sectional study We will be recruiting patients undergoing intravitreal injection for diabetic macular edema divided into 2 groups
Group 1 diabetic patients with macular edema no OSA
Group 2 diabetic patients with macular edema and OSA
All patients will undergo baseline ophthalmologic examination as part of a regular clinic visit including best-corrected visual acuity intraocular pressure slit lamp exam dilated retinal exam fluorescein angiography and optical coherence tomography OCT Diagnosis of diabetic macular edema will be confirmed with standard domain OCT Diagnosis of OSA will be confirmed through gold standard of overnight polysomnography
Data including demographics ocular history best corrected visual acuity IOP blood sugar control and sleep metrics will be collected Serum and aqueous fluid samples will be collected at time of first intravitreal injection including VEGF Placental growth factor TGFB ICAM-1IL-2 IL-3 IL-6 IL-8 IL-10IL-17 VCAM-1 MCP-1 Epidermal growth factor Pigment epithelial derived factor PEDF Angiotensin 2 and Platelet derived growth factor PDGF
Primary outcome
Levels of cytokine in serum and aqueous humour
Secondary outcome
Best-corrected visual acuity
Data analysis
Level of cytokines in serum and aqueous humor in patients with and without OSA will be compared using T test Statistical significance is defined as p 005
This will be a single centre prospective cross-sectional study We will be recruiting patients undergoing intravitreal injection for diabetic macular edema divided into 2 groups
Group 1 diabetic patients with macular edema no OSA
Group 2 diabetic patients with macular edema and OSA
All patients will undergo baseline ophthalmologic examination as part of a regular clinic visit including best-corrected visual acuity intraocular pressure slit lamp exam dilated retinal exam fluorescein angiography and optical coherence tomography OCT Diagnosis of diabetic macular edema will be confirmed with standard domain OCT Diagnosis of OSA will be confirmed through gold standard of overnight polysomnography
Data including demographics ocular history best corrected visual acuity IOP blood sugar control and sleep metrics will be collected Serum and aqueous fluid samples will be collected at time of first intravitreal injection including VEGF Placental growth factor TGFB ICAM-1IL-2 IL-3 IL-6 IL-8 IL-10IL-17 VCAM-1 MCP-1 Epidermal growth factor Pigment epithelial derived factor PEDF Angiotensin 2 and Platelet derived growth factor PDGF
Primary outcome
Levels of cytokine in serum and aqueous humour
Secondary outcome
Best-corrected visual acuity
Data analysis
Level of cytokines in serum and aqueous humor in patients with and without OSA will be compared using T test Statistical significance is defined as p 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None