Evaluation of Diabetic Retinopathy Using Ultra-Widefield Scanning Laser Ophthalmoscopy Compared With Two-Field Fundus Photography

Sponsor

Ningbo Eye Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05836194

Collaborator

(none)

752

Enrollment

Location

16.9

Anticipated Duration (Months)

44.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

As of 2030,9.7% (108.4 million) people in the China population have diabetes, and the total costs of diabetes in adults would reach $460.4 billion. Diabetic retinopathy (DR) and diabetic macular oedema (DME) are the principal causes of adult vision loss. Nevertheless,DR has few visual symptoms until DME occurs or the lessions located in the peripheral retina.Thus,it is crucial to early diagnosis and treatment of DR patients,which 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 dilation,experienced photographers and image montage.To simplify the operation process and improve patient compliance,2-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 screening. 2-field 45° retinal photographs has been proven beneficial in reducing blindness resulting from DR,while may be neglected DR pathology in the peripheral retina.With the development of imaging technology, nonmydriatic ultra-widefield scanning laser opthoalmascopy (optomap) can obtain high-resolution,widefield images (180-200°) of the retina in only 0.25s. 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 settings,espesially in predominantly peripheral lession(PPL).

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Diseases Diabetic Retinopathy Diabetes Complications Diabetes Mellitus Screening

Study Design

Study Type:

Observational

Anticipated Enrollment :

752 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Comparison of Ultra-Widefield Scanning Laser Ophthalmoscopy and Two-Field Fundus Photography for Evaluating Diabetic Retinopathy

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

The International Clinical Diabetic Retinopathy Disease Severity Scale within the 2-fields fundus photography and Ultra-Wide field scanning laser ophthalmoscopy (Optomap) imaging and statistical comparison [60 days]
To compare nonmydriatic 2-fields fundus photographs with nonmydriatic ultra-wide field images for determining diabetic retinopathy(DR) severity. DR severity level agreement will be cross-tabulated, and Kappa value will be calculated.

Secondary Outcome Measures

Number of Ungradable Images within the 2-field fundus photography and Optomap imaging [7 day]
The proportion and reasons of ungradable images will be documented.
Number of predominantly peripheral lession(PPL) with Optomap imaging [7 day]
The proportion of PPL images will be documented