Comparison Study of Funduscopic Exam of Pediatric Patients Using the D-EYE Method and Conventional Indirect Ophthalmoscopic Methods

Purpose: The D-EYE device, a new fundoscopic smartphone lens, has demonstrated its utility in a clinical setting to detect and document ocular pathology, but has not been tested in the pediatric population. A prospective study was performed to explore the application of D-EYE in pediatric fundus examinations. Methods: Patients ages 3 - 18 years old underwent dilated fundus examinations by masked examiners using the video function of the D-EYE, while indirect ophthalmoscopy was performed by apediatric ophthalmologist. The examiners independently analyzed the D-EYE videos for the presence or absence of abnormalities, cup-to-disc (c/d) ratios and optic nerve size and color. The D-EYE video findings were compared to indirect ophthalmoscopy findings. Results: The study included 172 eyes from 87 patients. In comparing D-EYE to indirect ophthalmoscopy for detecting fundus abnormalities, the sensitivity was 0.72, specificity was 0.97, positive predictive value (PPV) was 0.77, negative predictive value (NPV) was 0.97, positive likelihood ratio (LR) was 27.8, and negative LR was 0.29. The agreement rate between the D-EYE video graders for the c/d ratio within a value of 0.1 was 97.0%. Multiple, distinct abnormalities were discovered using the D-EYE device, including nystagmus, optic nerve hypoplasia, optic disc edema, peripapillary atrophy, disc pallor, and optic disc drusen. Conclusion: Fundoscopic imaging using the D-EYE smartphone lens reliably detects the presence of fundus abnormalities and has good reliability in assessing c/d ratios. The video capability is useful in patients with nystagmus or those who are poorly compliant with the examination and allowed for effective teaching by the pediatric ophthalmologist.