Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836194
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2023-04-18
Brief Title:
Evaluation of Diabetic Retinopathy Using Ultra-Widefield Fundus Images Compared With Two-Field Fundus Images
Sponsor:
Ningbo Eye Hospital
Organization:
Ningbo Eye Hospital
Study Overview
Official Title:
Comparison of Ultra-Widefield Scanning Laser Ophthalmoscopy and Two-Field Fundus Photography for Evaluating Diabetic Retinopathy
Status:
COMPLETED
Status Verified Date:
2024-08
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:
This study aims to compare the accuracy of evaluating diabetic retinopathy using ultra-widefield fundus images versus two-field fundus images The hypothesis is that screening and grading diabetic retinopathy based on ultra-widefield fundus images may yield higher accuracy compared to the use of two-field fundus images
Detailed Description:
As of 203097 1084 million people in the China population have diabetes and the total costs of diabetes in adults would reach 4604 billion Diabetic retinopathy DR and diabetic macular oedema DME are the principal causes of adult vision loss NeverthelessDR has few visual symptoms until DME occurs or the lessions located in the peripheral retinaThusit is crucial to early diagnosis and treatment of DR patientswhich will prevent vision loss and reduce the societal buren of diabetes
The Early Treatment Diabetic Retinopathy Study ETDRS standard 7-field 30 color fundus photography is a time-consuming examination requiring pharmacological pupil dilationexperienced photographers and image montageTo simplify the operation process and improve patient compliance2-field 45 retinal photographs 1 macular-centered field and 1 disc-centerde field was proposed in the EURODIAB IDDM complications study and widely used in DR screeningTwo-field 45 retinal photographs has been proven beneficial in reducing blindness resulting from DRwhile may be neglected DR pathology in the peripheral retinaWith the development of imaging technology nonmydriatic ultra-widefield scanning laser opthoalmascopy optomap can obtain high-resolutionwidefield images 180-200 of the retina in only 025s Optomap had good agreement with 7-field ETDRS in determining DR and DME severity and may be profitable in DR evaluation in research and clinical settingsespesially in predominantly peripheral lessionPPL
Patients with DM with or without known DR will be imaged using the optomap and 2-field 45 retinal photographs imaging device both for diagnosis and screening purposes at Ningbo Eye Hospital Internal validation and continuous quality control will routinely be conducted According to the International Clinical Diabetic Retinopathy Disease Severity Scale the data for the ungradable image rate distribution of DR severity levels and PPL will be evaluated and compared Statistics analysis will explore the agreement of DR severity levels between optomap images and 2-field photographs
The Early Treatment Diabetic Retinopathy Study ETDRS standard 7-field 30 color fundus photography is a time-consuming examination requiring pharmacological pupil dilationexperienced photographers and image montageTo simplify the operation process and improve patient compliance2-field 45 retinal photographs 1 macular-centered field and 1 disc-centerde field was proposed in the EURODIAB IDDM complications study and widely used in DR screeningTwo-field 45 retinal photographs has been proven beneficial in reducing blindness resulting from DRwhile may be neglected DR pathology in the peripheral retinaWith the development of imaging technology nonmydriatic ultra-widefield scanning laser opthoalmascopy optomap can obtain high-resolutionwidefield images 180-200 of the retina in only 025s Optomap had good agreement with 7-field ETDRS in determining DR and DME severity and may be profitable in DR evaluation in research and clinical settingsespesially in predominantly peripheral lessionPPL
Patients with DM with or without known DR will be imaged using the optomap and 2-field 45 retinal photographs imaging device both for diagnosis and screening purposes at Ningbo Eye Hospital Internal validation and continuous quality control will routinely be conducted According to the International Clinical Diabetic Retinopathy Disease Severity Scale the data for the ungradable image rate distribution of DR severity levels and PPL will be evaluated and compared Statistics analysis will explore the agreement of DR severity levels between optomap images and 2-field photographs
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