Performance of a New Tabletop Non-mydriatic Fundus Camera for Single-Field Diabetic Retinopathy Detection: A Pilot...

Area of Science:

• Ophthalmology
• Medical Imaging
• Diabetology

Background:

• Diabetic retinopathy (DR) detection typically utilizes fundus cameras.
• Evidence for non-mydriatic fundus cameras with limited technical challenges in DR detection is scarce.
• This pilot study evaluates a novel non-mydriatic tabletop fundus camera for DR detection.

Purpose of the Study:

• To evaluate the performance of the Oivi fundus camera for DR detection.
• To compare its diagnostic accuracy against a standard reference device (Topcon NW400).
• To assess the feasibility of a single-field, macula-centered imaging approach.

Main Methods:

• 243 subjects with diabetes mellitus (DM) were recruited.
• Non-mydriatic, macula-centered images were captured using both Oivi and Topcon cameras.
• Two ophthalmologists independently graded images; discrepancies were resolved by consensus, with senior ophthalmologist's grading of standard camera images as ground truth.

Main Results:

• The Oivi camera demonstrated high diagnostic accuracy for DR, with sensitivity of 92.98% and specificity of 99.47%.
• DR detection rates were similar between the Oivi (23.86%) and standard (23%) cameras.
• The Oivi camera yielded a higher percentage of usable images (95.2%) compared to the standard camera (92.3%).
• Excellent inter-modality agreement (κ = 0.927) was observed for DR detection.

Conclusions:

• The Oivi tabletop fundus camera shows comparable performance to standard non-mydriatic devices for DR detection.
• Its portability and usability suggest potential for point-of-care screening in diabetic patients.
• Further large-scale studies are recommended to validate these findings for screening programs.