Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 11, 2023
Date Accepted: Apr 2, 2024
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The Utility of a Smartphone-Based Retinal Imaging Device as a Screening Tool in an Outpatient Clinic Setting: Protocol for Randomized Controlled Trial
ABSTRACT
Background:
Glaucoma, a disease leading to the degeneration of retinal ganglion cells, results in changes to the optic nerve head that are often diagnosed late when visual problems arise. Digital ophthalmoscopes have emerged as a technology that utilizes smartphone cameras with an attachment on the lens to visualize the retina and optic nerve head without the need for dilation. The purpose of this pilot study is to examine the difference between still images and 30-second video analysis of the funduscopic captures from the D-EYE, digital ophthalmoscope, to determine what modality is most effective for clinicians to utilize as a glaucoma screening tool.
Objective:
The purpose of this study is to determine the accuracy in ocular disease screening using the D-EYE Smartphone-based Retinal Imaging System. The goal is to identify if this new instrument will be a cost-effective, accessible alternative to traditional retinal fundus camera imaging which requires an on-site ophthalmologist, and high cost equipment.
Methods:
The randomized pilot study enrolled 110 patients receiving an eye care exam at University of Florida Health from February 2019 to February 2020 to assess the utility of the D-EYE device in capturing still images and 30-second videos of the retina/optic nerve from both eyes in each participant. Study participants completed a survey to gather demographics and past medical history data with a particular focus on known eye health. Images were reviewed by 5 ophthalmology residents with inter-rater reliability analysis performed to assess findings.
Results:
One hundred and ten persons were enrolled into this study while receiving routine eye care at University of Florida Health (Gainesville, FL, USA). The pilot study indicated greater visualizability and clarity after ophthalmology resident review through 30-second videos of retinal imaging compared to still image ophthalmic capture.. Furthermore, the cup-to-disc measurement was more reliably measured in the 30-second video group due to greater visualizability and clarity in the imaging captures. Additionally, likelihood of referral between the glaucomatous and healthy sample groups indicated a greater sensitivity of digital ophthalmoscopes being able to detect retinal abnormalities, supporting the technology’s use as a screening tool.
Conclusions:
Our investigation suggests the utilization of smartphone-based digital ophthalmoscopes can be more effectively applied as a screening tool by capturing 30-second videos compared to still images alone. This novel assessment of an emerging technology in the field of ophthalmology may better equip further research as phone camera technology advances.
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