Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000134921
Ethics application status
Approved
Date submitted
13/01/2020
Date registered
11/02/2020
Date last updated
16/07/2021
Date data sharing statement initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Fundoscopy Use in Neurology Departments and the Utility of SmartPhone photography (FUNDUS)
Scientific title
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
Secondary ID [1] 300247 0
None
Universal Trial Number (UTN)
U1111-1246-3945
Trial acronym
FUNDUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Headache 315807 0
Neurological disturbance 315808 0
Condition category
Condition code
Neurological 314099 314099 0 0
Other neurological disorders
Eye 314341 314341 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316519 0
Early detection / Screening
Comparator / control treatment
Direct ophthalmoscopy using either a traditional direct ophthalmoscope or PanOptic ophthalmoscope as performed at the patient bedside by the treating neurology team members and documented in the medical record.

A second historical comparator will be obtained from retrospective data review to identify comparative practice patterns. Medical records of patients admitted to under the care of neurology during the same date range one year prior to the study, during study hours, and meeting study inclusion and exclusion criteria.
Outcomes recorded will include documentation of funduscopy performance and findings.
Control group
Active

Outcomes
Primary outcome [1] 322486 0
Period prevalence of fundoscopic pathology in patients admitted to hospital under the care of neurology, as detected by a reference clinical gold standard of blinded neurologist assessment of NMFP photographs
Timepoint [1] 322486 0
Four months post-study commencement
Secondary outcome [1] 378670 0
Observed proportion of neurology inpatients and neurology consults that have fundoscopy performed as usual care by their neurology teams during business hours between 0800 and 1630.
Timepoint [1] 378670 0
Four months post-study commencement
Secondary outcome [2] 378671 0
Proportion of pathology detected by neurology using direct ophthalmoscopy (or Panoptic) in routine clinical practice
Timepoint [2] 378671 0
Four months post-study commencement
Secondary outcome [3] 378672 0
Proportion of pathology detected by blinded neurologist assessment of SF performed by research assistants
Timepoint [3] 378672 0
Four months post-study commencement

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to provide informed consent/assent
* Fundus photography documented in the medical record prior to recruitment (Westmead Hospital)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computerised allocation concealment. Randomisation will only be performed once the participant is enrolled and has completed their baseline data acquisition to avoid recruitment bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
All participants will have routine care including fundoscopy as determined by their treating neurology team who will be aware of the trial. After this is performed, patients will be offered participation in the trial.
At least 60 minutes washout time between neurology team fundoscopy and study fundus imaging will be mandated. Randomisation will determine the first study fundus imaging with either SF or NMC. At least 5 minutes will be mandated between SF or NMC imaging and the crossover to the alternate technology.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The reference clinical standard for diagnostic testing analyses will be the blinded assessment of NMC photos by a neurologist who will have access to clinical information.
To determine the sensitivity of SF by medical students with a 10% width to the 95% CI at 5% alpha, a prospective cohort of 395 participants will be required [based on estimated Sn of 0.72 from [1]]. Similar confidence intervals for Specificity (based on Sp 0.92) would only require 16 participants. To determine the sensitivity of direct ophthalmoscopy (including panoptic) by neurology team assuming a Sn of 0.5 for would require a prospective cohort of 490 patients. [2]
Assuming 6 neurology inpatients enrolled daily at each site (Monday-Friday) yields 480 participants over the 8-week trial period.
Fundoscopic pathology rates detected by routine care, SP and novel routine NMC use will be compared using a Chi-square test (or Fisher exact test if low numbers require non-parametric testing).
Associations and correlations between current clinical practice and SF compared with NMC, will be explored in the study cohort using standard statistical methods such as percentage agreement, Kappa and McNemar’s test. Associations between diagnosis and prevalence of fundus pathology will be explored using linear and proportional hazards regression models.
To determine the comparative proportion of neurology patients with fundus pathology in the historical cohort at a significance level of 5%, a power of 80%, using 2-sided equality with an estimated 5% difference in the pathology detection rate from a baseline of 13%, the minimum sample size required is 341 patients in the historical cohort.

1. Dickson, D., et al., Comparison Study of Funduscopic Exam of Pediatric Patients Using the D-EYE Method and Conventional Indirect Ophthalmoscopic Methods. Open Journal of Ophthalmology, 2017. Vol.07No.03: p. 8.
2. Fenn, B.N.M., Statistical Methodology: I. Incorporating the Prevalence of Disease into the Sample Size Calculation for Sensitivity and Specificity. Academic Emergency Medicine, 1996. 3(9): p. 895-900.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
17/02/2020
Actual
17/02/2020
Date of last participant enrolment
Anticipated
28/07/2023
Actual
21/02/2020
Date of last data collection
Anticipated
24/07/2020
Actual
Sample size
Target
490
Accrual to date
76
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15609 0
Westmead Hospital - Westmead
Recruitment hospital [2] 15610 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 29009 0
2145 - Westmead
Recruitment postcode(s) [2] 29010 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 304672 0
Hospital
Name [1] 304672 0
Westmead Hospital, Dept of Neurology & Dept of Ophthalmology
Country [1] 304672 0
Australia
Funding source category [2] 304838 0
Hospital
Name [2] 304838 0
Royal North Shore Hospital
Country [2] 304838 0
Australia
Primary sponsor type
University
Name
Discipline of Clinical Ophthalmology & Eye Health, Faculty of Medicine & Health, University of Sydney
Address
Save Sight Institute
South Block, Sydney Eye Hospital
8 Macquarie Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 305171 0
None
Name [1] 305171 0
Address [1] 305171 0
Country [1] 305171 0
Other collaborator category [1] 281131 0
Commercial sector/Industry
Name [1] 281131 0
Welch Allyn / Hill Rom
Address [1] 281131 0
Suite 4.01, 2-4 Lyonpark Rd
Macquarie Park, NSW 2113
Country [1] 281131 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305093 0
WSLHD Human Research Ethics Committee
Ethics committee address [1] 305093 0
Ethics committee country [1] 305093 0
Australia
Date submitted for ethics approval [1] 305093 0
29/11/2018
Approval date [1] 305093 0
18/01/2019
Ethics approval number [1] 305093 0
AU RED HREC/19/WMEAD/3

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99246 0
A/Prof Andrew White
Address 99246 0
Department of Ophthalmology
B4a Westmead Hospital,
166-174 Darcy Road
Westmead, NSW 2145
Country 99246 0
Australia
Phone 99246 0
+61 2 8890 6668
Fax 99246 0
+61 2 8890 6117
Email 99246 0
andrew.white@sydney.edu.au
Contact person for public queries
Name 99247 0
Hamish Dunn
Address 99247 0
Port Macquarie Eye Centre
35 Ackroyd St, Port Macquarie, NSW 2444
Country 99247 0
Australia
Phone 99247 0
+61 2 6584 5554
Fax 99247 0
+61 2 6584 5553
Email 99247 0
hamish.dunn@sydney.edu.au
Contact person for scientific queries
Name 99248 0
Hamish Dunn
Address 99248 0
Port Macquarie Eye Centre
35 Ackroyd St, Port Macquarie, NSW 2444
Country 99248 0
Australia
Phone 99248 0
+61 2 6584 5554
Fax 99248 0
+61 2 6584 5553
Email 99248 0
hamish.dunn@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifying data including diagnostic coding of grading by the neurology team, SF and NMFP.
When will data be available (start and end dates)?
January 2021 - January 2023
Available to whom?
Researchers who provide a methodologically sound proposal on a case-by-case basis with approval obtained through WSLHD ethics committee.
Available for what types of analyses?
IPD for meta-analayses and other analyses on a case-by-case basis.
How or where can data be obtained?
Application to Investigators (contact: hamish.dunn@sydney.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6401Study protocol  hamish.dunn@sydney.edu.au
6402Informed consent form  hamish.dunn@sydney.edu.au
6403Ethical approval  hamish.dunn@sydney.edu.au



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFundoscopy use in neurology departments and the utility of smartphone photography: a prospective prevalence and crossover diagnostic accuracy study amongst neurology inpatients.2022https://dx.doi.org/10.1111/ene.15390
N.B. These documents automatically identified may not have been verified by the study sponsor.