Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT06272851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring Choroidal Thickness Using Optical Coherence Tomography
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Comparing the Choroidal Thickness Using Optical Coherence Tomography Between the Eyes of Healthy Individuals and Diabetic Patients Without Retinopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
To compare the choroidal thickness in eyes of diabetic patients with eyes of age matched controls using optical coherence tomography.
Detailed Description:
Diabetic retinopathy (DR) is the most common and specific complication of DM. It is one of the leading causes of preventable blindness in the adult working population. (1) DR was the fifth leading cause of blindness and of moderate and severe vision impairment.
Global prevalence of diabetic retinopathy was 22.27% and prevalence was highest in Africa (35.90%). (1)
Fortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have declined over the past few decades due to advances in ocular disease assessment, screening, imaging and treatment in recent years. (2)
The outer third of the retina gets oxygen and nutrients from choroid. The three vascular layers of choroid are chorio capillaries layer, Sattler layer and Haller layer. (3)
A healthy choroid is essential for retinal function by continuous perfusion into the outer retina, which plays critical roles in thermoregulation of the retina, maintenance of the anatomic position of the retina, removal of residues, and secretion of growth factors. (4-5)
The vascular choroid changes of the diabetic patients are quite similar to those seen in DR, such as increased vascular tortuosity, vascular outpouchings, microaneurysms, nonperfusion areas, vascular dilations and narrowing, and choroidal neovascularization. (6)
Until recently, the choroid could only be evaluated by indocyanine green angiography, laser Doppler flowmetry, and ultrasonography. (6) Optical coherence tomography (OCT) is a non-invasive imaging modality, which is used in acquiring high-resolution sections of retina. (5)
Global prevalence of diabetic retinopathy was 22.27% and prevalence was highest in Africa (35.90%). (1)
Fortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have declined over the past few decades due to advances in ocular disease assessment, screening, imaging and treatment in recent years. (2)
The outer third of the retina gets oxygen and nutrients from choroid. The three vascular layers of choroid are chorio capillaries layer, Sattler layer and Haller layer. (3)
A healthy choroid is essential for retinal function by continuous perfusion into the outer retina, which plays critical roles in thermoregulation of the retina, maintenance of the anatomic position of the retina, removal of residues, and secretion of growth factors. (4-5)
The vascular choroid changes of the diabetic patients are quite similar to those seen in DR, such as increased vascular tortuosity, vascular outpouchings, microaneurysms, nonperfusion areas, vascular dilations and narrowing, and choroidal neovascularization. (6)
Until recently, the choroid could only be evaluated by indocyanine green angiography, laser Doppler flowmetry, and ultrasonography. (6) Optical coherence tomography (OCT) is a non-invasive imaging modality, which is used in acquiring high-resolution sections of retina. (5)
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?: