Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04935749
Status:
RECRUITING
Last Update Posted:
2021-06-23
First Post:
2021-05-29
Brief Title:
Epidemiologic Assessment of Diabetic Retinopathy in Egypt Using Ultrawide Field Fundus Photographs
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Epidemiologic Assessment of Diabetic Retinopathy in Egypt Using Ultrawide Field Fundus Photographs
Status:
RECRUITING
Status Verified Date:
2021-06
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:
In 2013 it was estimated that 16 75 million of all Egyptian adults between the ages of 20 and 79 years have type 2 diabetes and 26 million have diabetic retinopathy A small pilot study looking at 323 patients with previously diagnosed diabetes mellitus DM and 183 patients with newly diagnosed DM found that the prevalence of diabetic retinopathy DR was 483 and 104 in each group respectively By 2035 the Middle Eastern Region and Egypt is projected to have an over 96 increase in the diabetes population
Ultrawide field UWF imaging is a novel technology that allows the visualization of approximately 82 of the retina in a single image Its use in diabetic retinopathy DR has been widely explored both as a diagnostic as well as a screening tool Using this technology more of the peripheral retina can be readily visualized allowing significantly greater hemorrhagesmicroaneurysms intraretinal microvascular abnormalities and non-perfusion to be detected UWF imaging in patients with DM allowed the identification of a distinct sub-set of eyes with lesions that are predominantly distributed in the peripheral retina Eyes with significantly greater DR lesions in the extended peripheral fields compared to their respective ETDRS fields are said to have predominantly peripheral lesions or PPL Eyes with PPL are at greater risk of progressing to more advanced DR and developing proliferative diabetic retinopathy PDR after 4 years of follow up The increased risk of vision threatening complications in eyes with PPL has made the identification of these eyes an essential part of DR evaluation and screening Furthermore the presence of lesions in the peripheral retina results in a more severe DR grade in approximately 20 of eyes thereby making this tool more accurate at grading DR severity A recent DRCR retina network multicenter study established earlier findings confirming the validity of this tool in DR management
I-care Ophthalmology Center will acquire the first UWF device in Egypt the Optos California Optos Plc Dunfermline Scanning laser ophthalmoscopy UWF imaging has been approved by both the FDA and EMA since 2011 Patients with DM with or without known DR will be imaged using the UWF imaging device both for diagnosis and screening purposes at I-care Ophthalmology center after informed consent These images will be graded for the level of retinopathy and the presenceabsence of PPL by certified trained graders Internal validation and continuous quality control will routinely be conducted Patients with vision threatening retinopathy moderate non-proliferative diabetic retinopathy or worse or the presence of diabetic macular edema will be instructed to come back for further retinal evaluation and ancillary testing Patients with mild retinopathy will be instructed to come for yearly follow up imaging The expected duration for data collection will be 5-years with interim data analysis on a yearly basis The design although cross sectional will have a prospective sub-analysis group in patients who have repeat imaging
Data collection and imaging will be conducted in Egypt and anonymized deidentified data will be shared with the Joslin Diabetes Center Harvard Ophthalmology Department for joint research purposes Data will be analyzed for the prevalence of DR and the distribution of DR severity levels in the studied population In addition the presence and absence of PPL and its association with DR progression will be studied Non-modifiable duration of DM age of onset type of DM etc and modifiable risk factors HbA1c hypertension hyperlipidemia etc for increased risk of DR progression will also be analyzed Sensitivity analysis will explore the sensitivityspecificity of initial DR grading compared to trained retina specialists
Ultrawide field UWF imaging is a novel technology that allows the visualization of approximately 82 of the retina in a single image Its use in diabetic retinopathy DR has been widely explored both as a diagnostic as well as a screening tool Using this technology more of the peripheral retina can be readily visualized allowing significantly greater hemorrhagesmicroaneurysms intraretinal microvascular abnormalities and non-perfusion to be detected UWF imaging in patients with DM allowed the identification of a distinct sub-set of eyes with lesions that are predominantly distributed in the peripheral retina Eyes with significantly greater DR lesions in the extended peripheral fields compared to their respective ETDRS fields are said to have predominantly peripheral lesions or PPL Eyes with PPL are at greater risk of progressing to more advanced DR and developing proliferative diabetic retinopathy PDR after 4 years of follow up The increased risk of vision threatening complications in eyes with PPL has made the identification of these eyes an essential part of DR evaluation and screening Furthermore the presence of lesions in the peripheral retina results in a more severe DR grade in approximately 20 of eyes thereby making this tool more accurate at grading DR severity A recent DRCR retina network multicenter study established earlier findings confirming the validity of this tool in DR management
I-care Ophthalmology Center will acquire the first UWF device in Egypt the Optos California Optos Plc Dunfermline Scanning laser ophthalmoscopy UWF imaging has been approved by both the FDA and EMA since 2011 Patients with DM with or without known DR will be imaged using the UWF imaging device both for diagnosis and screening purposes at I-care Ophthalmology center after informed consent These images will be graded for the level of retinopathy and the presenceabsence of PPL by certified trained graders Internal validation and continuous quality control will routinely be conducted Patients with vision threatening retinopathy moderate non-proliferative diabetic retinopathy or worse or the presence of diabetic macular edema will be instructed to come back for further retinal evaluation and ancillary testing Patients with mild retinopathy will be instructed to come for yearly follow up imaging The expected duration for data collection will be 5-years with interim data analysis on a yearly basis The design although cross sectional will have a prospective sub-analysis group in patients who have repeat imaging
Data collection and imaging will be conducted in Egypt and anonymized deidentified data will be shared with the Joslin Diabetes Center Harvard Ophthalmology Department for joint research purposes Data will be analyzed for the prevalence of DR and the distribution of DR severity levels in the studied population In addition the presence and absence of PPL and its association with DR progression will be studied Non-modifiable duration of DM age of onset type of DM etc and modifiable risk factors HbA1c hypertension hyperlipidemia etc for increased risk of DR progression will also be analyzed Sensitivity analysis will explore the sensitivityspecificity of initial DR grading compared to trained retina specialists
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None