Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000283673
Ethics application status
Approved
Date submitted
23/02/2023
Date registered
16/03/2023
Date last updated
16/03/2023
Date data sharing statement initially provided
16/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The 4eyesVision Kit: Training Community Health Workers in vision assessment.
Scientific title
The 4eyesVision kit: Training Community Health Workers in measurement of visual acuity and refractive error.
Secondary ID [1] 308924 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vision Impairment (VI) 328931 0
Uncorrected Refractive Error (URE) 328932 0
Condition category
Condition code
Eye 325919 325919 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study are referred to as 'Trainee community testers'.

Trainee community testers will complete one 4-hour face-to-face group training session to be delivered by the Principal Investigator who is an eye health specialist. The training content will address epidemiology of vision impairment and how to measure visual acuity and refractive error using the 4eyesVision Kit. The 4eyesVision Kit includes a field-friendly phoropter and tripod, spectacle frames and corrective lenses ranging in magnification. The 4-hour training session will involve demonstrations, interactive activities and time for practice and testing. The training will be supported by a training manual which will be provided on an electronic tablet during the training and supported by a hard copy version for Trainee community testers to keep following the training. Participants will then practice applying this knowledge by testing the vision of their fellow Trainee community testers and recording their answers. They will also be asked to complete a task where they determine the refraction of a corrective lens provided by the trainer and record their answer. Trainee community testers will complete a qualitative survey before the training ('Pre-training survey') to determine any prior training in eye health and knowledge of corrective glass use in their community. Trainee community testers will also complete a qualitative survey after the training ('Post-training survey') to determine feedback on the training.
Intervention code [1] 325509 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333969 0
True Positive Rate of visual acuity measured by Trainee community testers compared to visual acuity measured by eye health specialist. Visual acuity to be measured by use of 'Tumbling E' chart.
Timepoint [1] 333969 0
At completion of each visual acuity measurement task performed by Trainee community testers.
Primary outcome [2] 333970 0
True Positive Rate of refractive error measured by Trainee community testers compared to refractive error measured by eye health specialist. Refractive error will be measured using the 4eyesVision phoropter.
Timepoint [2] 333970 0
At completion of each refractive error measurement task performed by Trainee community testers.
Primary outcome [3] 333971 0
True Positive Rate of selection of corrective lenses by Trainee community testers compared to selection of corrective lenses by eye health specialist. The Tumbling E chart and phoropter results will be used to select appropriate corrective lenses by following the flowchart in the training manual.
Timepoint [3] 333971 0
At completion of selection of corrective lenses task by Trainee community testers.
Secondary outcome [1] 418891 0
Feasibility of completing a qualitative 'Pre-training survey' by Trainee community testers. The Pre-training survey was designed for this study and will collect data on prior knowledge of eye health and spectacle use in the community.
Timepoint [1] 418891 0
Immediately following consent of Trainee community testers.
Secondary outcome [2] 418892 0
Feasibility of completing a qualitative 'Post-training survey' by Trainee community testers. The Post-training survey was designed for this study and will collect data on acceptability of the training course and training manual.
Timepoint [2] 418892 0
Immediately following completion of training by Trainee community testers.

Eligibility
Key inclusion criteria
Trainee community testers:
> Aged 18 years plus
> Employed as Community Health Worker at study site
> Able to speak and read English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size is not intended to enable generalisation to broader populations, but to gain an in-depth understanding in the specific participant sample. The sample size is pre-determined by the number of Community Health Workers employed at the study sites.

For visual acuity and refractive error measurements:
A true-positive analysis will be used to assess accuracy of values determined by Trainee community testers compared to values determined by the eye health specialist. A t-test will be performed on the two sets of values for each individual (Trainee community tester vs. eye health specialist), providing an estimate of the rate difference (with a 95% CI).

For choice of corrective lenses:
A true-positive analysis will be used to assess accuracy of corrective lens choice determined by Trainee community testers compared to corrective lens choice determined by the eye health specialist.

For survey data:
Qualitative data will be analysed using a thematic analysis approach by compiling and then disassembling responses to determine key themes. Noting the relatively small size of the anticipated dataset, a manual approach will be used rather than a software-based approach reliant on NVivo. An inductive approach will be used for identification of key themes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
Date of last participant enrolment
Anticipated
24/03/2023
Actual
Date of last data collection
Anticipated
24/03/2023
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 25286 0
Papua New Guinea
State/province [1] 25286 0
North Province

Funding & Sponsors
Funding source category [1] 313133 0
Charities/Societies/Foundations
Name [1] 313133 0
4eyesVision
Country [1] 313133 0
Australia
Funding source category [2] 313275 0
Charities/Societies/Foundations
Name [2] 313275 0
Kokoda Track Foundation
Country [2] 313275 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
4eyesVision
Address
3 Arthur Street, Randwick, NSW, 2031, Australia
Country
Australia
Secondary sponsor category [1] 315014 0
None
Name [1] 315014 0
Address [1] 315014 0
Country [1] 315014 0
Other collaborator category [1] 282569 0
Individual
Name [1] 282569 0
Elissa Mortimer, Principal Consultant-EMC Global
Address [1] 282569 0
EMC Global, C/- PHEHF, 88 Wakefield Street, Adelaide, SA, 5000.
Country [1] 282569 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312378 0
Royal Australian and New Zealand College of Ophthalmologists (RANZCO)
Ethics committee address [1] 312378 0
94-98 Chalmers Street, Surry Hills, NSW, 2010
Ethics committee country [1] 312378 0
Australia
Date submitted for ethics approval [1] 312378 0
19/12/2022
Approval date [1] 312378 0
30/01/2023
Ethics approval number [1] 312378 0
149.22
Ethics committee name [2] 312506 0
Government of Papua New Guinea, Medical Research Advisory Committee
Ethics committee address [2] 312506 0
PO Box 807, Waigani 131, NCD
Ethics committee country [2] 312506 0
Papua New Guinea
Date submitted for ethics approval [2] 312506 0
21/02/2023
Approval date [2] 312506 0
Ethics approval number [2] 312506 0

Summary
Brief summary
4eyesVision has developed a field-friendly kit for testing the two things that are essential in assessing whether corrective lenses can improve vision: visual acuity and refractive error. The 4eyesVision Kit allows people who have not had any prior training or experience in eye health ('Trainee community testers') to learn how to test vision based on a short training with an eye health professional. The kit includes frames and corrective lenses which can be assembled after visual acuity and refractive error measurement by the Trainee community testers,

This study will investigate:
1. accuracy of visual acuity and refractive error measurement by non-professional workforces (under supervision by an eye health professional);
2. capacity of these workforces to choose appropriate corrective lenses (under supervision by an eye health professional).

Study hypothesis:
That Trainee community testers will determine visual acuity and refractive error measurements to the same degree of accuracy as an eye health specialist following participation in a 4-hour training.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124446 0
Dr Sarah Crowe
Address 124446 0
4eyesVision, 3 Arthur Street, Randwick, NSW, 2031
Country 124446 0
Australia
Phone 124446 0
+61 410523536
Fax 124446 0
Email 124446 0
sarah@4eyesfoundation.org
Contact person for public queries
Name 124447 0
Ms Elissa Mortimer
Address 124447 0
EMC Global, 88 Wakefield Street, Adelaide, SA, 5000, Australia.
Country 124447 0
Australia
Phone 124447 0
+61 415 216 907
Fax 124447 0
Email 124447 0
elissa@emcglobal.com.au
Contact person for scientific queries
Name 124448 0
Dr Sarah Crowe
Address 124448 0
4eyesVision, 3 Arthur Street, Randwick, NSW, 2031
Country 124448 0
Australia
Phone 124448 0
+61 410523536
Fax 124448 0
Email 124448 0
sarah@4eyesfoundation.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It may impact on participant engagement if IPD is made public since the primary objective of the study is to determine accuracy of visual acuity and refractive error measurements and choice of corrective lenses by Trainee community testers.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18436Informed consent form    385347-(Uploaded-23-02-2023-17-14-19)-Study-related document.docx



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.