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Trial registered on ANZCTR


Registration number
ACTRN12619000767101
Ethics application status
Approved
Date submitted
7/05/2019
Date registered
22/05/2019
Date last updated
22/05/2019
Date data sharing statement initially provided
22/05/2019
Date results information initially provided
22/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Utility of fundus photography versus ophthalmoscopy in Australian emergency department settings
Scientific title
Utility of non-mydriatic digital fundus photography in Australian emergency department settings: the FOTO-ED (Fundus photography vs. Ophthalmoscopy Trial Outcomes in the Emergency Department) extension trial
Secondary ID [1] 298220 0
Nil known
Universal Trial Number (UTN)
U1111-1232-1578
Trial acronym
Australian FOTO-ED Extension Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Headache 312500 0
Visual disturbance 312501 0
Neurological disturbance 312502 0
Severe hypertension 312503 0
Condition category
Condition code
Emergency medicine 311045 311045 0 0
Other emergency care
Neurological 311046 311046 0 0
Other neurological disorders
Eye 311047 311047 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Name: Non-mydriatic fundus photography (NMFP)
*VisuCam registered trade mark (Zeiss, Oberkochen, Germany): table-mounted camera provided to enrolled patients in the eye examination room in RPA Hospital Emergency Department (ED)
*RetinaVUE registered trade mark (Welch Allyn, Macquarie Park, Australia): portable camera provided to enrolled patients at the bedside in Westmead Hospital ED
*performed in the ED by a nurse, physician or medical student researcher with prior computer-based and face-to-face NMFP training
*administered once during the ED admission, taking approximately 2-10 minutes for complete examination of both eyes
*digital fundus images are loaded to the patient electronic medical record
*fundus images are then interpreted by the treating emergency physician
*fundus images are then reviewed by the local ophthalmology team (and a study investigator)
*any urgent clinical considerations discovered on routine image review are discussed with the treating ED team
*screening protocol adherence monitored by comparing enrolment data with hospital records of ED admissions
Intervention code [1] 314268 0
Early detection / Screening
Intervention code [2] 314269 0
Diagnosis / Prognosis
Intervention code [3] 314456 0
Treatment: Devices
Comparator / control treatment
Retrospective data review to identify comparative practice patterns. Medical records of patients admitted to EDs during the same date range one year prior to the study, during study hours, and meeting study inclusion and exclusion criteria on the basis of triage and hospital coding.
Outcomes recorded included documentation of funduscopy performed by ED using direct ophthalmoscopy, and any neurology or ophthalmology consultation for a reference standard.
Control group
Historical

Outcomes
Primary outcome [1] 319837 0
Period prevalence of fundus pathology amongst patients presenting to ED with any of the four entry criteria
Timepoint [1] 319837 0
Eight weeks
Secondary outcome [1] 369642 0
Proportions of eligible patients examined at each ED using a fixed fundus camera (ED site 1) compared with a portable fundus camera (ED site 2).
*Measured by study log compared with hospital ED admissions records.
Timepoint [1] 369642 0
Eight weeks
Secondary outcome [2] 369643 0
Proportions of pathological and normal fundi correctly identified by emergency physicians, compared with the reference standard of review by ophthalmology (+/- a neuro-ophthalmologist masked to clinical details and prior interpretations)
*Measured by study-specific questionnaire
Timepoint [2] 369643 0
Within 48 hours of fundus image aquisition
Secondary outcome [3] 369644 0
Perceived clinical utility of fundus photographs to emergency physicians
*Measured by 5-point Likert scale
Timepoint [3] 369644 0
At the time of fundus image review
Secondary outcome [4] 369645 0
Time to acquire photographs
*Measured by digital timer and recorded in the study specific questionnaire.
Timepoint [4] 369645 0
At the time of fundus image acquisition
Secondary outcome [5] 369646 0
Fundus photograph quality as assessed by the local ophthalmology team (independent of the trial investigators) and a masked neuro-ophthalmogist.
*Measured by study-specific 5-point scale (Lamirel et al. Quality of Nonmydriatic Digital Fundus Photography Obtained by Nurse Practitioners in the Emergency Department: The FOTO-ED Study, Ophthalmology, Vol 119:3, ,2012,p617-624, ISSN 0161-6420, https://doi.org/10.1016/j.ophtha.2011.09.013.)
Timepoint [5] 369646 0
At the time of fundus image review.
Secondary outcome [6] 370114 0
Determine the percentage of cases in which the findings of nonmydriatic fundus photography
impact on diagnosis or management in the emergency setting
*Measured by study specific questionnaire
Timepoint [6] 370114 0
At the time of discharge from ED
Secondary outcome [7] 370367 0
Compare clinical practice patterns amongst enrolled patients in the retrospective and prospective cohorts regarding subspecialty consultation.
*Measured by study specific questionnaire and hospital medical records.
Timepoint [7] 370367 0
Time of discharge from hospital
Secondary outcome [8] 370368 0
Compare clinical practice patterns amongst enrolled patients in the retrospective and prospective cohorts regarding duration of ED stay.
*Measured by study specific questionnaire and hospital medical records.
Timepoint [8] 370368 0
Time of discharge from hospital
Secondary outcome [9] 370369 0
Compare clinical practice patterns amongst enrolled patients in the retrospective and prospective cohorts regarding neuroimaging investigations ordered.
*Measured by study specific questionnaire and hospital medical records.
Timepoint [9] 370369 0
Time of discharge from hospital
Secondary outcome [10] 370370 0
Compare clinical practice patterns amongst enrolled patients in the retrospective and prospective cohorts regarding lumbar puncture performance.
*Measured by study specific questionnaire and hospital medical records.
Timepoint [10] 370370 0
Time of discharge from hospital

Eligibility
Key inclusion criteria
Patients presenting to ED Monday-Friday between the hours of 8am - 5pm with:
*Headache
*New neurological disturbance (defined as motor and/or sensory deficits, speech impairment or dizziness)
*Visual disturbance
*Severe hypertension (defined as diastolic blood pressure greater than 120mmHg)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to give informed consent: normal guardianship consent hospital regulations will be followed
* Medically unstable: once immediate care is provided and the patient is deemed medically stable, inclusion may be considered
* Self-discharge from ED prior to medical review

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Prospective, cross-sectional, single group study of NMFP
Historical, non-interventional, medical record control group
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
*Potential prospective eligible participants were estimated based on analysis of past admission coding data: (ED1: 2-10 patients per day, ED2: 8-15 patients per day). An eight-week trial period was determined based on availability of research staff to ensure data integrity for period prevalence outcome.
*For the primary outcome of period prevalence of fundus pathology in the prospective cohort, the minimum sample size was calculated at 174 patients for the prospective dataset, such that the prevalence of fundus pathology could be estimated, using an estimated prevalence of 13% (from previous the US FOTO-ED Phase 1 trial), and desired precision of 5% (ie 95% CI 8-18%).
* For the secondary outcome of comparative pathology detection rate at a significance level of 5%, a power of 80% and the estimated difference in the pathology pick up rate between the direct ophthalmoscopy and fundus cameras of 13% (based on FOTO-ED Phase 1 trial), the minimum sample size required is 53 patients in each study arm. However, this sample size was set at 174 for each study arm due to the number of participants needed for the primary outcome.
*Statistical analysis performed using SPSS (version 15.0; SPSS Inc., Chicago, IL).
*Period prevalence of fundus pathology and site outcomes compared using the Chi-squared test.
*Continuous data reported as medians and interquartile ranges (IQR), and categorical data as percentages.
*Statistical significance set at 0.05%.
*Inter-rater agreement calculated using observed agreement and Cohen's kappa.
*Diagnostic accuracy of NMFP determined using consensus fundus imaging grading by local and masked ophthalmologists as the reference standard.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13696 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 13697 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 26388 0
2050 - Camperdown
Recruitment postcode(s) [2] 26389 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 302566 0
University
Name [1] 302566 0
Summer Research Scholarship, University of Sydney School of Medicine
Address [1] 302566 0
Edward Ford Building (A27) Fisher Road
University of Sydney, NSW 2006
Country [1] 302566 0
Australia
Funding source category [2] 302568 0
Commercial sector/Industry
Name [2] 302568 0
Hill-Rom Australia
Address [2] 302568 0
Suite 4.01, 2-4 Lyonpark Rd
Macquarie Park, NSW 2113
Country [2] 302568 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] 302477 0
None
Name [1] 302477 0
Address [1] 302477 0
Country [1] 302477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303211 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 303211 0
Research Ethics & Governance Office
210A, Level 2, RPAH Medical Centre 100 Carillon Ave Newtown NSW 2042
Ethics committee country [1] 303211 0
Australia
Date submitted for ethics approval [1] 303211 0
19/05/2017
Approval date [1] 303211 0
07/09/2017
Ethics approval number [1] 303211 0
HREC/15/RPAH/355

Summary
Brief summary
Funduscopy is not widely performed, to the detriment of patients whose vision-threatening and life-threatening disorders may not be detected. The decline of fundoscopy has been ascribed to technical challenges of the examination, and difficulties interpreting the findings. Non-mydriatic fundus photography (NMFP) has been demonstrated to improve detection of fundus abnormalities in patients presenting to the emergency department (ED). We aim to determine the prevalence of fundus abnormalities amongst selected patients presenting to Australian EDs, and the clinical impact of NMFP for these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92866 0
Prof Peter McCluskey
Address 92866 0
Discipline of Clinical Ophthalmology & Eye Health, Faculty of Medicine & Health, University of Sydney
Save Sight Institute
South Block, Sydney / Sydney Eye Hospital
8 Macquarie Street
Sydney NSW 2000
Country 92866 0
Australia
Phone 92866 0
+61 2 9382 7300
Fax 92866 0
Email 92866 0
peter.mccluskey@sydney.edu.au
Contact person for public queries
Name 92867 0
Mrs Alison Pryke
Address 92867 0
Dept of Ophthalmology
B4a Westmead Hospital
PO Box 533 Wentworthville NSW 2145
Country 92867 0
Australia
Phone 92867 0
+61 2 8890 3644
Fax 92867 0
+61 2 9845 3170
Email 92867 0
alison.pryke@health.nsw.gov.au
Contact person for scientific queries
Name 92868 0
Dr Hamish Dunn
Address 92868 0
Dept of Ophthalmology
B4a Westmead Hospital
PO Box 533 Wentworthville NSW 2145
Country 92868 0
Australia
Phone 92868 0
+61 2 8890 3644
Fax 92868 0
Email 92868 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?
Individual, de-identified data underlying published results.
When will data be available (start and end dates)?
Beginning 6 months after and ending 3 years after publication of main results.
Available to whom?
Researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator, requirement to sign data access agreement and approval by the Sydney Local Health District HREC.
What supporting documents are/will be available?
Study protocol
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary