ANZCTR - Registration

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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

3/06/2021

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]

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

Visual disturbance

Neurological disturbance

Severe hypertension

Condition category

Condition code

Emergency medicine

Other emergency care

Neurological

Other neurological disorders

Eye

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]

Early detection / Screening

Intervention code [2]

Diagnosis / Prognosis

Intervention code [3]

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]

Period prevalence of fundus pathology amongst patients presenting to ED with any of the four entry criteria

Timepoint [1]

Eight weeks

Secondary outcome [1]

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]

Eight weeks

Secondary outcome [2]

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]

Within 48 hours of fundus image aquisition

Secondary outcome [3]

Perceived clinical utility of fundus photographs to emergency physicians
*Measured by 5-point Likert scale

Timepoint [3]

At the time of fundus image review

Secondary outcome [4]

Time to acquire photographs
*Measured by digital timer and recorded in the study specific questionnaire.

Timepoint [4]

At the time of fundus image acquisition

Secondary outcome [5]

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]

At the time of fundus image review.

Secondary outcome [6]

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]

At the time of discharge from ED

Secondary outcome [7]

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]

Time of discharge from hospital

Secondary outcome [8]

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]

Time of discharge from hospital

Secondary outcome [9]

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]

Time of discharge from hospital

Secondary outcome [10]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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)

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 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

30/11/2017

Date of last participant enrolment

Anticipated

Actual

17/01/2018

Date of last data collection

Anticipated

Actual

18/01/2018

Sample size

Target

348

Accrual to date

Final

942

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

Westmead Hospital - Westmead

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

2145 - Westmead

Funding & Sponsors

Funding source category [1]

University

Name [1]

Summer Research Scholarship, University of Sydney School of Medicine

Address [1]

Edward Ford Building (A27) Fisher Road
University of Sydney, NSW 2006

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Hill-Rom Australia

Address [2]

Suite 4.01, 2-4 Lyonpark Rd
Macquarie Park, NSW 2113

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

Research Ethics & Governance Office
210A, Level 2, RPAH Medical Centre 100 Carillon Ave Newtown NSW 2042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/05/2017

Approval date [1]

07/09/2017

Ethics approval number [1]

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

Prof Peter McCluskey

Address

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

Australia

Phone

+61 2 9382 7300

Fax

[email protected]

Contact person for public queries

Name

Mrs Alison Pryke

Address

Dept of Ophthalmology
B4a Westmead Hospital
PO Box 533 Wentworthville NSW 2145

Country

Australia

Phone

+61 2 8890 3644

Fax

+61 2 9845 3170

[email protected]

Contact person for scientific queries

Name

Dr Hamish Dunn

Address

Dept of Ophthalmology
B4a Westmead Hospital
PO Box 533 Wentworthville NSW 2145

Country

Australia

Phone

+61 2 8890 3644

Fax

[email protected]

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?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Dunn HP, Teo KZ, Smyth JW, Weerasinghe LS, Costell... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Using non-mydriatic fundus photography to detect fundus pathology in Australian metropolitan emergency departments: A prospective prevalence and diagnostic accuracy study.	2021	https://dx.doi.org/10.1111/1742-6723.13619

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically