Diabetic Retinopathy and Subclinical Signs of Disease Transition

Study Overview
=================
Brief Summary
-----------------
The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment. Some factors are known to temporarily aggravate or improve diabetic retinopathy, but underlying pathophysiologic factors are still unknown. High-resolution imaging techniques of the retina and its supplying vascular networks now allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In detail, the investigators image study patients with optical coherence tomography (OCT) - technology, that provides morphological information of retinal structure and the supplying vessels in a non-invasive way. Retinal layer thickness as well as capillary density will be quantified and followed in patients that are in a critical period of disease transition to better understand the process of diabetic retinopathy.

Official Title
-----------------
Diabetic Retinopathy and Subclinical Signs of Disease Transition

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Diagnostic Test: Optical Coherence Tomography Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus type 1 or 2 Age 18-90 Exclusion Criteria: Media opacities like cataract or vitreous hemorrhage Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye Structural damage to the center of macula in the study eye Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques Ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intensified blood glucose control<br>Patients with diabetes mellitus type 2 and poor blood sugar control that are introduced to insulin or GLP-1 therapy | Diagnostic Test: Optical Coherence Tomography Angiography<br>* Retinal scans will be acquired at each follow up visit<br>* Other names: Optical Coherence Tomography;|
| Nephropathy<br>Patients that are introduced to hemodialysis or renal transplantation secondary to renal failure | Diagnostic Test: Optical Coherence Tomography Angiography<br>* Retinal scans will be acquired at each follow up visit<br>* Other names: Optical Coherence Tomography;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion density | Mean change of perfusion density of the macula evaluated within the 9 ETDRS subfields for the superior and inferior vascular plexus separately. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfusion density | Mean change of perfusion density of the macula evaluated within the 9 ETDRS subfields for the superior and inferior vascular plexus separately. | 12 months | 
| Retinal layer thickness | Mean change in retinal layer thickness of all retinal layers separately | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Imaging, OCTA