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Trial registered on ANZCTR


Registration number
ACTRN12620000274976
Ethics application status
Approved
Date submitted
21/02/2020
Date registered
2/03/2020
Date last updated
2/03/2020
Date data sharing statement initially provided
2/03/2020
Date results information initially provided
2/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The utility non-mydriatic fundus photography in a regional Australian emergency department
Scientific title
The impact of non-mydriatic fundus photography on patient management in a regional Australian emergency department setting
Secondary ID [1] 299455 0
Nil Known
Universal Trial Number (UTN)
U1111-1241-2635
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
headache 314663 0
visual disturbance 314664 0
neurological disturbance 314665 0
hypertensive urgency 314666 0
Condition category
Condition code
Emergency medicine 312994 312994 0 0
Other emergency care
Neurological 312995 312995 0 0
Other neurological disorders
Eye 312996 312996 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Name: Non-mydriatic fundus photography (NMFP)
*RetinaVUE registered trade mark (Welch Allyn, Macquarie Park, Australia): portable camera provided to enrolled patients at the bedside 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 study electronic medical record
*during daytime hours (Monday-Friday 8:30-5pm) results of a direct ophthalmoscopy examination and baseline management plan documentation are recorded (see comparator intervention), THEN fundus images are provided to the treating emergency physician and interpretation and management plan changes are recorded on a study-specific questionnaire
*outside daytime study hours ED physicians were free to use the NMFP or DO as they wished
*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] 315698 0
Diagnosis / Prognosis
Intervention code [2] 315699 0
Treatment: Devices
Intervention code [3] 315700 0
Early detection / Screening
Comparator / control treatment
Direct Ophthalmoscopy
*performed at the patient bedside by the treating ED physician
*baseline management plan is recorded using a study-specific questionnaire
*these items are recorded before the fundus photograph is shown to the ED physician during daytime hours (Monday-Friday 8:30-5pm)
Control group
Active

Outcomes
Primary outcome [1] 321565 0
The proportion of patients amongst whom the addition of fundus photography results in a change to emergency management.
* changes to management by ED physicians, and additional changes requested after telemedicine ophthalmic review as determined by study specific questionnaire will be included
Timepoint [1] 321565 0
Changes within 48hours of enrolment will be assessed
Proportions will be determined after 5 months trial completion
Secondary outcome [1] 375360 0
The diagnostic accuracy of direct ophthalmoscopy by ED physicians compared to fundus photography review by ophthalmology for detecting acute abnormalities.
* as determined by study-specific questionnaire
* reference standard ophthalmology review will include review by an Ophthalmology Registrar and a consultant ophthalmologist with access to clinical presentation information. Where there is a disagreement in findings, a neuro-ophthalmologist masked to previous reviews will provide grading and the consensus opinion will become the reference clinical standard.
* sub-analyses planned to determine any relationship between ED physician level of training and diagnostic accuracy
Timepoint [1] 375360 0
Within 48 hours of fundus image acquisition
Secondary outcome [2] 375361 0
The period prevalence of funduscopic pathology amongst patients presenting to a regional ED
* as determined by reference standard ophthalmology consensus grading
Timepoint [2] 375361 0
5 months post-intervention commencement
Secondary outcome [3] 380391 0
Time to acquire photographs
*Measured by digital timer and recorded in the study specific questionnaire.
Timepoint [3] 380391 0
At the time of fundus image acquisition
Secondary outcome [4] 380392 0
Fundus photograph quality as assessed by the ophthalmology team.
*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 [4] 380392 0
At the time of fundus image acquisition

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
*Hypertensive urgency (defined as a diastolic blood pressure over 110 mmHg, and/or a systolic blood pressure over 180 mmHg)
Minimum age
4 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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
All participants will receive both fundus viewing interventions in a specific (non-randomised) sequence during the study. They act as their own control. ED physician (1) direct ophthalmoscopy and baseline management plan will be recorded BEFORE a research assistant will provide ED physicians with access to (2) the fundus photographs
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
For the primary outcome of a change in patient management, a binomial test for difference calculated the minimum sample size at 140 patients for the prospective dataset, using an estimated treatment effect of 20%, required precision of 5% and a power of 80%. A 5-month trial period was established based on the volume of eligible ED presentations noted from the corresponding time-frame the year prior. Disagreement between the ophthalmology registrar and consultant ophthalmologist review of fundus images will be mediated via third-party neuro-ophthalmologist review masked to previous assessments.

Statistical analysis will be performed using STATA (version 16; StataCorp, College Station, TX). Continuous data will be reported as medians and interquartile ranges. The patient will be the unit of analysis. Statistical significance is set at 0.05%. Proportions will be reported as point-estimates with 95% confidence intervals (95%CI), Confidence intervals will be calculated using the binomial distribution where applicable. ED physician diagnostic accuracy analysis will exclude fundus photographs with non-urgent but vision-threatening chronic conditions. Non-parametric data will be analysed using repeated-measure analysis of variance (ANOVA), chi-square, and Wilcoxon signed rank tests as appropriate. Logistic regression will be performed for ED physician fundus image interpretation accuracy and post-graduate-year comparison analysis.

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] 15939 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment postcode(s) [1] 29423 0
2444 - Port Macquarie

Funding & Sponsors
Funding source category [1] 303956 0
Commercial sector/Industry
Name [1] 303956 0
Hill-Rom Australia
Address [1] 303956 0
Suite 4.01, 2-4 Lyonpark Rd
Macquarie Park, NSW 2113
Country [1] 303956 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] 304120 0
Hospital
Name [1] 304120 0
Mid North Coast Local Health District
Address [1] 304120 0
Morton Street
PORT MACQUARIE NSW 2444
Country [1] 304120 0
Australia
Secondary sponsor category [2] 305400 0
University
Name [2] 305400 0
University of NSW, Rural Clinical School
Address [2] 305400 0
26 Highfields Circuit
Port Macquarie,
NSW, 2444
Country [2] 305400 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304456 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 304456 0
Research Ethics & Governance Office
210A, Level 2, RPAH Medical Centre 100 Carillon Ave Newtown NSW 2042
Ethics committee country [1] 304456 0
Australia
Date submitted for ethics approval [1] 304456 0
22/02/2018
Approval date [1] 304456 0
01/05/2018
Ethics approval number [1] 304456 0
HREC/15/RPAH/355

Summary
Brief summary
Fundoscopy (looking at the back of the eye) is extremely valuable but rarely done as the traditional direct ophthalmoscope is hard to use. The consequence is delay to diagnosis or missed diagnosis of potentially critical eye and whole body conditions.
Digital fundus photography has been demonstrated as a superior alternative to direct ophthalmoscopy, detecting problems amongst 10-18% of relevant emergency department (ED) patients in metropolitan hospitals. We aim to determine how often fundus photography improves the management of patients, and the prevalence of fundus pathology in a regional setting.
We hypothesise that fundus photography will:
1. change the management of patients in the ED;
2. be more accurate in diagnosis than direct ophthalmoscopy;
3. detect a rate of pathology similar to that found in metropolitan EDs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97010 0
Prof Peter McCluskey
Address 97010 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 97010 0
Australia
Phone 97010 0
+61 2 9382 7300
Fax 97010 0
Email 97010 0
peter.mccluskey@sydney.edu.au
Contact person for public queries
Name 97011 0
Dr Hamish Dunn
Address 97011 0
Port Macquarie Eye Centre
35 Ackroyd St,
Port Macquarie
NSW 2444
Country 97011 0
Australia
Phone 97011 0
+61 2 6585 5554
Fax 97011 0
Email 97011 0
hamish.dunn@sydney.edu.au
Contact person for scientific queries
Name 97012 0
Dr Hamish Dunn
Address 97012 0
Port Macquarie Eye Centre
35 Ackroyd St,
Port Macquarie
NSW 2444
Country 97012 0
Australia
Phone 97012 0
+61 2 6585 5554
Fax 97012 0
Email 97012 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?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Reasonable requests to achieve the aims of the research proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator Peter McCluskey or Co-ordinating Investigator Dr Hamish Dunn (hamish.dunn@sydney.edu.au), with a requirement to sign data access agreement and approval by the Sydney Local Health District HREC.
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7024 0
Study protocol
Citation [1] 7024 0
Link [1] 7024 0
Email [1] 7024 0
hamish.dunn@sydney.edu.au
Other [1] 7024 0
Attachment [1] 7024 0
Type [2] 7025 0
Informed consent form
Citation [2] 7025 0
Link [2] 7025 0
Email [2] 7025 0
hamish.dunn@sydney.edu.au
Other [2] 7025 0
Attachment [2] 7025 0
Type [3] 7026 0
Ethical approval
Citation [3] 7026 0
Link [3] 7026 0
Email [3] 7026 0
hamish.dunn@sydney.edu.au
Other [3] 7026 0
Attachment [3] 7026 0
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?
Yes
Other publication details
Citation type [1] 7027 0
Conference abstract
Citation/DOI/link/details [1] 7027 0
https://doi.org/10.1111/ceo.13632
Browning. S., Dunn, H.P., Thomson D., Yates W., Keay L., White A., McCluskey P., Fraser C. Non-mydriatic fundus photography in a regional Australian emergency department. Clin Exp Ophthalmol, 2019.((Suppl I)):p156.
Attachments [1] 7027 0
Results – basic reporting
Results – plain English summary