ANZCTR - Registration

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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 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]

Nil Known

Universal Trial Number (UTN)

U1111-1241-2635

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

headache

visual disturbance

neurological disturbance

hypertensive urgency

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)
*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]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Devices

Intervention code [3]

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]

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]

Changes within 48hours of enrolment will be assessed
Proportions will be determined after 5 months trial completion

Secondary outcome [1]

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]

Within 48 hours of fundus image acquisition

Secondary outcome [2]

The period prevalence of funduscopic pathology amongst patients presenting to a regional ED
* as determined by reference standard ophthalmology consensus grading

Timepoint [2]

5 months post-intervention commencement

Secondary outcome [3]

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

Timepoint [3]

At the time of fundus image acquisition

Secondary outcome [4]

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]

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

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)

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

3/03/2019

Date of last participant enrolment

Anticipated

Actual

2/08/2019

Date of last data collection

Anticipated

Actual

6/08/2019

Sample size

Target

140

Accrual to date

Final

133

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Port Macquarie Base Hospital - Port Macquarie

Recruitment postcode(s) [1]

2444 - Port Macquarie

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Hill-Rom Australia

Address [1]

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

Country [1]

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]

Hospital

Name [1]

Mid North Coast Local Health District

Address [1]

Morton Street
PORT MACQUARIE NSW 2444

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of NSW, Rural Clinical School

Address [2]

26 Highfields Circuit
Port Macquarie,
NSW, 2444

Country [2]

Australia

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]

22/02/2018

Approval date [1]

01/05/2018

Ethics approval number [1]

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

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

Hamish Dunn

Address

Port Macquarie Eye Centre
35 Ackroyd St,
Port Macquarie
NSW 2444

Country

Australia

Phone

+61 2 6585 5554

Fax

[email protected]

Contact person for scientific queries

Name

Hamish Dunn

Address

Port Macquarie Eye Centre
35 Ackroyd St,
Port Macquarie
NSW 2444

Country

Australia

Phone

+61 2 6585 5554

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?

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 ([email protected]), with a requirement to sign data access agreement and approval by the Sydney Local Health District HREC.

What supporting documents are/will be available?

Doc. No.	Type	Email
7024	Study protocol	[email protected]
7025	Informed consent form	[email protected]
7026	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Impact on patient management of non-mydriatic fundus photography compared to direct ophthalmoscopy in a regional Australian emergency department.	2022	https://dx.doi.org/10.1111/1742-6723.13845

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

Trial Review

Documents added manually

Documents added automatically