None listed
Conditions
Brief summary
Headache is the fourth most common chief complaint in the ED. Optic disc oedema, characterized by optic nerve swelling from intracranial hypertension, is one of the most important red flags that prompts timely further evaluation of life-threatening headache. However, examination of the optic nerve is infrequently and poorly performed by ED physicians. While artificial intelligence has enabled the automated detection of optic disc oedema from retinal images, these AI systems have not been clinically validated in real-world settings. A group of researchers from the Centre for Eye Research Australia, Monash and Melbourne university have worked with Eyetelligence Ltd to develop the world’s first hardware-software integrated system (i.e. AI-powered Smart Camera) to screen the retinal red flag of headache automatically. We hypothesize that the Smart Camera system will demonstrate reasonably good feasibility, accuracy and end-user acceptance in screening for red flags of life-threatening headache in the Emergency Department.
Interventions
The smart camera is a portable and fully automated non-mydriatic retinal camera that will be integrated with an AI model to detect retinal red flags. It guides patients through the retinal imaging process with voice prompts. The associate investigator will provide three hours of face-to-face training two weeks before the first participant enrollment.
Upon consent, participants will undergo non-mydriatic retinal photography for both eyes. Participants will not be dilated and images will be taken
The smart camera is a portable and fully automated non-mydriatic retinal camera that will be integrated with an AI model to detect retinal red flags. It guides patients through the retinal imaging process with voice prompts. The associate investigator will provide three hours of face-to-face training two weeks before the first participant enrollment. Upon consent, participants will undergo non-mydriatic retinal photography for both eyes. Participants will not be dilated and images will be taken for both eyes. A trained clinical trial research assistant of the research team will take the retinal images for the participants, which takes around 5-10 minutes. If the image quality is insufficient (graded as "ungradable" by the artificial intelligence system), research assistants will try up to three attempts to get good-quality images. The session will be delivered in a one-on-one and face-to-face mode. The fundus images obtained will be uploaded and reviewed by an ophthalmologist within 96 hours. The ophthalmologist will assess the quality of images captured by the Smart Camera, and provide grading notes for the images and follow-up recommendations. If the ophthalmologist finds any issues that need further follow-up by eye care practitioners, the participant will be informed via email or through postal mail. By the end of this trial, all fundus images will be run through the AI algorithm and AI grading results will be generated. Besides retinal photography, participants will be asked to complete a socio-demographic/headache survey during the visit, and a satisfaction survey about their experiences of using the screening system during the visit or through email if not completed on site. Adherence will be determined by the completion status on the RedCap platform which is recorded by the research assistants. The focus group interviews aim to gain a deeper understanding of perceptions regarding the Smart Camera screening service, including the facilitators and barriers to using this system in real-world practice. By the end of this trial, participants and clinicians or support staff will be randomly selected to participate in focus groups and/or in-depth interviews. The size of each group will not exceed 10 people. The maximum number of participants will be determined when the thematic saturation is reached. The focus groups interviews will be conducted by qualitative research experts from our research group.
Sponsors
Centre for Eye Research Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients in the Emergency Department who meet the following criteria are considered eligible for the study. (1) are 18 years or older; (2) are able to give informed consent and adhere to study procedures; (3) have English language capacity; (4) have a chief complaint of headaches; (5) have been triaged as level 3 to 5 on the Australasian Triage Scale, an index of clinical urgency from 1 that requires immediate assessment and treatment to 5 that can be assessed and treated within 2 hours.
Exclusion criteria
Patients who meet any of the following criteria will not be included in the study: (1) have unstable vital signs; (2) have a change in consciousness level; (3) are unable to comply with the requirements of informed consent or the screening protocol.
Outcome results
None listed