ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Vision Impairment (VI)

Uncorrected Refractive Error (URE)

Condition category

Condition code

Eye

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At completion of each visual acuity measurement task performed by Trainee community testers.

Primary outcome [2]

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]

At completion of each refractive error measurement task performed by Trainee community testers.

Primary outcome [3]

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]

At completion of selection of corrective lenses task by Trainee community testers.

Secondary outcome [1]

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]

Immediately following consent of Trainee community testers.

Secondary outcome [2]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Papua New Guinea

State/province [1]

North Province

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

4eyesVision

Address [1]

3 Arthur Street Randwick NSW 2031 Australia

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Kokoda Track Foundation

Address [2]

Level 1, 274 Darling Street
Balmain, NSW, 2041
Australia

Country [2]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

4eyesVision

Address

3 Arthur Street, Randwick, NSW, 2031, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Elissa Mortimer, Principal Consultant-EMC Global

Address [1]

EMC Global, C/- PHEHF, 88 Wakefield Street, Adelaide, SA, 5000.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Australian and New Zealand College of Ophthalmologists (RANZCO)

Ethics committee address [1]

94-98 Chalmers Street, Surry Hills, NSW, 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/12/2022

Approval date [1]

30/01/2023

Ethics approval number [1]

149.22

Ethics committee name [2]

Government of Papua New Guinea, Medical Research Advisory Committee

Ethics committee address [2]

PO Box 807, Waigani 131, NCD

Ethics committee country [2]

Papua New Guinea

Date submitted for ethics approval [2]

21/02/2023

Approval date [2]

Ethics approval number [2]

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

Dr Sarah Crowe

Address

4eyesVision, 3 Arthur Street, Randwick, NSW, 2031

Country

Australia

Phone

+61 410523536

Fax

sarah@4eyesfoundation.org

Contact person for public queries

Name

Elissa Mortimer

Address

EMC Global, 88 Wakefield Street, Adelaide, SA, 5000, Australia.

Country

Australia

Phone

+61 415 216 907

Fax

elissa@emcglobal.com.au

Contact person for scientific queries

Name

Sarah Crowe

Address

4eyesVision, 3 Arthur Street, Randwick, NSW, 2031

Country

Australia

Phone

+61 410523536

Fax

sarah@4eyesfoundation.org

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
18436	Informed 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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically