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Trial registered on ANZCTR


Registration number
ACTRN12619000659101p
Ethics application status
Submitted, not yet approved
Date submitted
1/04/2019
Date registered
2/05/2019
Date last updated
2/05/2019
Date data sharing statement initially provided
2/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening for diabetic eye disease in general practices in Victoria
Scientific title
Screening for diabetic retinopathy in general practices in Victoria. Does the current model work?
Secondary ID [1] 297854 0
None
Universal Trial Number (UTN)
U 1111-1230-9580
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 312227 0
Diabetic retinopathy 312228 0
Condition category
Condition code
Eye 310773 310773 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 310801 310801 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
As part of routine diabetes care, Medicare now allows for photographic screening to occur within general practices for anyone with diabetes. This study involves the testing of distance visual acuity and undilated retinal photographs using a Kowa nonmyd WX 3D camera at the selected general practices. The testing will be done by the trained practice nurse and the treating general practitioner will then assess the photographs for the presence or absence of diabetic retinopathy and report the results to the participant.
The entire testing procedure (vision testing and photography) will take approximately 15 minutes and participants will be required to return to the GP clinic for an appointment with their general practitioner to discuss the results. As part of this study the testing will be done one time only.
Regular contact with the practice nurse taking the photographs will occur to ensure that the protocol is adhered to as intended and to also support the practice in implementing the screening program.
Intervention code [1] 314091 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319621 0
The compliance rate of diabetic retinopathy screening at the selected screening sites which will be determined by the number of participants who will meet the eligibility criteria to undergo diabetic retinopathy screening.
Timepoint [1] 319621 0
After the completion of the screening period
Primary outcome [2] 319623 0
Rate of undiagnosed diabetic retinopathy.
This will be assessed by interpreting the retinal images taken from the Kowa nonmyd WX 3D camera for the presence or absence of diabetic retinopathy
Timepoint [2] 319623 0
After the completion of the screening period
Secondary outcome [1] 368906 0
Quality of retinal photos using Kowa nonmyd WX 3D camera.
Quality is defined by the image quality of the photographs which allows the assessor (the GP) to interpret them, i.e. the images are clear, focused and centered correctly.
Timepoint [1] 368906 0
After the completion of the screening period

Eligibility
Key inclusion criteria
Aged 18 years or above
Any form of diabetes mellitus
No history of diabetic retinopathy
Distance visual acuity of 6/12 or better
No more than 2 lines difference of visual acuity between the two eyes
Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged less than 18 years old
Previous or current diagnosis of diabetic retinopathy
Visual acuity less than 6/12
Greater than 2 lines difference of visual acuity between the two eyes

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
In a recent study, Crossland et al found that when using the traditional method of screening such as referral to an optometrist and to private or public eye clinics, the compliance rate varied between 22-53%. A sample size (based on this primary hypothesis) was computed under the assumption that to claim that the study delivers better compliance, a compliance rate of 63% or larger would be needed (i.e. 10% higher than the rate observed following referral). The resulting sample size is estimated to be 185 participants (0.05 significance level and 80% power).

It is envisaged that all the analyses will be conducted using Stata Version 14 (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/05/2019
Actual
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
185
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26151 0
3030 - Werribee
Recruitment postcode(s) [2] 26152 0
3805 - Narre Warren

Funding & Sponsors
Funding source category [1] 302379 0
Commercial sector/Industry
Name [1] 302379 0
Bayer Australia
Country [1] 302379 0
Australia
Primary sponsor type
Individual
Name
Dr Nandor Jaross
Address
Australian Eye Specialists. Level 1, 242 Hoppers Lane. Werribee VIC 3030
Country
Australia
Secondary sponsor category [1] 302265 0
None
Name [1] 302265 0
Address [1] 302265 0
Country [1] 302265 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303052 0
Bellberry Limited
Ethics committee address [1] 303052 0
Ethics committee country [1] 303052 0
Australia
Date submitted for ethics approval [1] 303052 0
06/02/2019
Approval date [1] 303052 0
Ethics approval number [1] 303052 0

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

Contacts
Principal investigator
Name 92294 0
Dr Nandor Jaross
Address 92294 0
Australian Eye Specialists. Level 1, 242 Hoppers Lane. Werribee Victoria 3030
Country 92294 0
Australia
Phone 92294 0
+61 1300 150 806
Fax 92294 0
Email 92294 0
nandor@australianeyespecialists.com
Contact person for public queries
Name 92295 0
Marian Saeed
Address 92295 0
Australian Eye Specialists. Level 1, 242 Hoppers Lane. Werribee Victoria 3030
Country 92295 0
Australia
Phone 92295 0
+61 1300 150 806
Fax 92295 0
Email 92295 0
marian@australianeyespecialists.com
Contact person for scientific queries
Name 92296 0
Marian Saeed
Address 92296 0
Australian Eye Specialists. Level 1, 242 Hoppers Lane. Werribee Victoria 3030
Country 92296 0
Australia
Phone 92296 0
+61 1300 150 806
Fax 92296 0
Email 92296 0
marian@australianeyespecialists.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is not envisaged that the IPD will be made public as we feel this is not necessary however upon request this can be reconsidered


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.