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

Abstract

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.

<p>Comparison of smartphone ophthalmoscopy vs conventional direct ophthalmoscopy as a teaching tool for medical students: the COSMOS study</p>

“…We used the D-EYE digital ophthalmoscope (D-EYE Srl, Padova, Italy), a magnetic lens that attaches to the smartphone via magnets to transform the smartphone into a portable fundus camera (Figure 1). The D-EYE is Food and Drug Administration approved as a fundus camera and also has a secure HIPAA compliant cloud software to store images 21. Clinical studies using the D-EYE have found it to be superior in detecting fundus findings of acute hypertension compared with direct ophthalmology in the ER setting, showed significant agreement with slit-lamp biomicroscopy in measuring vertical cup to disc ratios, and was comparable with indirect ophthalmoscopy in detecting fundus findings in pediatric patients 17,18,21,22…”

Smartphone ophthalmoscopy: patient and student practitioner perceptions

“…pathology grading systems) and for use within telehealth [ 20]. While there is evidence supporting use of smartphones in various areas of ophthalmology [20–23]; evidence of their usefulness as an educational tool is still emerging. Early reports suggest medical students view smartphone ophthalmoscopes favourably and are more likely to make correct and faster diagnoses than when using direct ophthalmoscopes [24, 25].…”

Fundoscopy use in neurology departments and the utility of smartphone photography: a prospective prevalence and crossover diagnostic accuracy study amongst neurology inpatients

“…The PanOptic iExaminer SF was shown to be effective in obtaining clinically adequate fundus images amongst 91% of 2–18‐year‐old children in the ED, but achieved only 16% amongst children 0–2 years old [42]. Likewise, the D‐EYE demonstrated good diagnostic agreement with the gold standard amongst a paediatric population [17].…”

“…To determine the specificity of SF compared with NMFP with a 10% width to the 95% CI at 5% α , a cohort of 16 participants would be required based on an estimated specificity of 0.92 from previous studies [17].…”