Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04648618 |
| Other study ID # |
OSA-DME 2 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Uptown Eye Specialists |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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-1,IL-2, IL-3, IL-6, IL-8, IL-10,IL-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 < 0.05.
