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Fundoscopy Use in Neurology Departments and the Utility of SmartPhone photography (FUNDUS)

Fundoscopy Use in Neurology Departments and the Utility of SmartPhone photography (FUNDUS): Determining the prevalence of fundus pathology amongst neurology inpatients, and comparing the diagnostic accuracy of direct ophthalmoscopy, smartphone fundoscopy and portable non-mydriatic fundus photography

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000134921
Acronym
FUNDUS
Enrollment
76
Registered
2020-02-11
Start date
2020-02-17
Completion date
2020-02-21
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Fundoscopy (looking at the back of the eye) offers a non-invasive glimpse of the brain and vasculature. Fundoscopy is therefore a core component of the general physical examination and critical to any neurological exam. Direct fundoscopy is technically challenging and difficult to interpret. This has resulted in a low rate of fundoscopy observed in retrospective studies of hospital inpatients. Neurology patients have an increased likelihood of fundus pathology which could alter their management. Novel fundus imaging technologies are available which minimise the current limitations of fundoscopy. This project will prospectively identify fundoscopic pathology amongst neurology inpatients, and compare practice patterns and diagnostic accuracy of current practice with available novel technologies to detect this pathology. The study aims are to evaluate the current fundoscopy practice in neurology departments, and assess the diagnostic accuracy of this current practice compared with systematic screening with smartphone funduscopy (SF) or portable non-mydriatic fundus photography (NMFP).

Interventions

After review and fundoscopy by the treating team, participants will have both non-mydriatic fundus photography and smartphone fundoscopy of both eyes. The order of the interventions will be randomised 1:1 after baseline data is collected. Intervention Name: (1) Non-mydriatic fundus photography (NMFP) *RetinaVUE registered trade mark (Welch Allyn, Macquarie Park, Australia): portable camera provided to enrolled patients at the bedside *performed by a medical student researcher with prior compute

After review and fundoscopy by the treating team, participants will have both non-mydriatic fundus photography and smartphone fundoscopy of both eyes. The order of the interventions will be randomised 1:1 after baseline data is collected. Intervention Name: (1) Non-mydriatic fundus photography (NMFP) *RetinaVUE registered trade mark (Welch Allyn, Macquarie Park, Australia): portable camera provided to enrolled patients at the bedside *performed by a medical student researcher with prior computer-based and face-to-face NMFP training *administered once during the hospital admission, taking approximately 2-10 minutes for complete examination of both eyes *fundus images are then interpreted by a neurologist investigator from a different hospital *any urgent clinical considerations discovered on routine image review are discussed with the treating team *screening protocol adherence monitored by comparing enrolment data with hospital records Intervention Name: (2) Smartphone fundoscopy (SF) * D-eye registered trade mark (Padova, Italy): provided to enrolled patients at the bedside *performed by a medical student researcher with prior computer-based and face-to-face SF training *administered once during the hospital admission, taking approximately 4-10 minutes for complete examination of both eyes *fundus images are then interpreted by a neurologist investigator from a different hospital *any urgent clinical considerations discovered on routine image review are discussed with the treating team At least 60 minutes washout time between neurology team fundoscopy and screening interventions will be mandated. At least 5 minutes washout time between SF and NMFP will be mandated.

Sponsors

Discipline of Clinical Ophthalmology & Eye Health, Faculty of Medicine & Health, University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients admitted under the care of neurology at Westmead and Royal North Shore Hospitals, and patients who have a formal neurology consult during business hours between 0800 and 1630

Exclusion criteria

* Inability to provide informed consent/assent * Fundus photography documented in the medical record prior to recruitment (Westmead Hospital)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026