Diagnostic performance of the offline Medios Artificial Intelligence (AI) for glaucoma detection in a rural tele-ophthalmology setting.

Purpose: This study assesses the diagnostic efficacy of offline Medios Artificial Intelligence (AI) glaucoma software in a primary eyecare setting, using non-mydriatic fundus images from Remidio's Fundus-on-Phone (FOP NM-10). AI results were compared with tele-ophthalmologists' diagnoses and with a glaucoma specialist's assessment for those participants referred to tertiary eyecare hospital.

Design: Prospective, cross-sectional study PARTICIPANTS: 303 participants from 6 satellite vision centers of a tertiary eye hospital METHODS: At the vision center, participants underwent comprehensive eye evaluations, including clinical history, visual acuity measurement, slit lamp examination, intraocular pressure measurement, and fundus photography using the FOP NM-10 camera. Medios AI-Glaucoma software analysed 42-degrees disc-centric fundus images, categorizing them as normal, glaucoma, or suspect. Tele-ophthalmologists who were glaucoma fellows with a minimum of 3 years of ophthalmology and 1 year of glaucoma fellowship training, masked to AI results, remotely diagnosed subjects based on the history and disc appearance. All participants labelled as disc suspects or glaucoma by AI or tele-ophthalmologists underwent further comprehensive glaucoma evaluation at the base hospital, including clinical examination, Humphrey visual field analysis (HFA), and Optical Coherence Tomography (OCT). AI and tele-ophthalmologist diagnoses were then compared with a glaucoma specialist's diagnosis.

Main outcome measures: Sensitivity and Specificity of Medios AI RESULTS: Out of 303 participants, 299 with at least one eye of sufficient image quality were included in the study. The remaining 4 participants did not have sufficient image quality in both eyes. Medios AI identified 39 participants (13%) with referable glaucoma. The AI exhibited a sensitivity of 0.91 (95% CI: 0.71 - 0.99) and specificity of 0.93 (95% CI: 0.89 - 0.96) in detecting referable glaucoma (definite perimetric glaucoma) when compared to tele-ophthalmologist. The agreement between AI and the glaucoma specialist was 80.3%, surpassing the 55.3.% agreement between the tele-ophthalmologist and the glaucoma specialist amongst those participants who were referred to the base hospital. Both AI and the tele-ophthalmologist relied on fundus photos for diagnoses, while the glaucoma specialist's assessments at the base hospital were aided by additional tools such as HFA and OCT. Furthermore, AI had fewer false positive referrals (2 out of 10) compared to the tele-ophthalmologist (9 out of 10).

Conclusion: Medios offline AI exhibited promising sensitivity and specificity in detecting referable glaucoma from remote vision centers in southern India when compared with teleophthalmologists. It also demonstrated better agreement with glaucoma specialist's diagnosis for referable glaucoma participants.