You are invited to take part in this research project, ‘Development and Validation of a Virtual Clinical Auditing Tool using Artificial Intelligence (AI) for Standardizing Glaucomatous Optic Neuropathy (GON) Detection in Optometry Settings’. This is because you are an optometrist in Australia. The research project aims to determine practice patterns of optometrists for glaucoma detection at initial comprehensive eye examinations.

As a clinician, your contribution is vital to improve the detection of GON in the Australian population. You are invited to participate in an online questionnaire to identify gaps in current practice in GON detection. This project is the first phase of a larger project to develop an AI clinical auditing tool for optometry settings.

This page tells you about the research project. Knowing what is involved will help you decide if you want to take part in the research.

Please read this information carefully. Contact the researchers to ask questions about anything that you don’t understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with a relative or colleague.

Participation in this research is voluntary. If you don’t wish to take part, you don’t have to.

If you decide you want to take part in the research project, your consent will be implied if you select ‘agree’ prior to completing the questionnaire. By selecting agree you are telling us that you:

• Understand what you have read
• Consent to take part in the research project
• Consent to the research that has been described
• Consent to the use of the information you provide to us as described.

Glaucoma is the leading cause of irreversible blindness globally, and the second leading cause of all blindness in Australia among people aged 55 and older. Optometrists serve as primary eye care providers in Australia. Clinical audits can be used to detect the amount of variance that exists from the current care provided, compared to the clinical standard of care. However, the manual auditing process can be labour-intensive, time-consuming, expensive and has the potential for subjective variation. AI addresses these challenges as it tends to provide consistent, cheap, and reliable assessment of the optic disc and retinal nerve fibre layer, therefore offering an opportunity to play a vital role in auditing GON detection in optometry.

Our study aim is to investigate the clinical practice patterns of GON detection and integrate AI into the development and validation of a clinical auditing tool for GON detection in optometry settings. This project focuses on comparing the results of optometrists to that of the AI.

The results of this research will be used by the investigator Catherine Jan to obtain a doctoral degree at the Department of Ophthalmology, University of Melbourne.

This research is being conducted by A/Prof. Peter van Wijngaarden.

This research has been funded by Medical Research Future Fund.

This research involves taking part in an online questionnaire about the current practice patterns of glaucoma detection in Australia and an online fundus image grading exercise. You are eligible to participate if you are registered with the Australian Health Practitioner Regulation (AHPRA) registered optometrist in Australia.

There are two options for participation in this research project. Participation is entirely voluntary and if you decide to participate, you may choose either option to participate in. Please note, you can only participate in one option, you cannot participate in both options.

Option 1: This is a prospective observational study to assess the variation in demographic and clinical characteristics among optometrists using a questionnaire, which will take approximately 10 minutes to complete. Following this, you will be presented with a short fundus image grading exercise, which will take approximately 30 minutes to complete. Both the questionnaire and the grading exercise will be conducted online.

Option 2: This is a prospective observational study to assess the variation in demographic and clinical characteristics among optometrists using a questionnaire, which will take approximately 10 minutes to complete. Following this, you will be presented a longer fundus image grading exercise, which will take approximately 3 hours to complete. Both the questionnaire and the grading exercise will be conducted online.

You may be contacted in future for further research assessing how artificial intelligence can be used as a support tool in optometry.

If you choose to participate in the study, you will need to read this plain language statement and select either option 1 or 2 by following the relevant link below. This link will direct you to complete an online questionnaire and the relevant fundus image grading exercise, the length of the grading exercise will depend on whether you choose option 1 or 2. For the fundus image grading exercise, by participating in this project, you agree not to make a copy, reproduce, or use these images in any way that is not related to this research project.

Approximately 50 optometrists around Australia will be recruited to option 1 of this study and 10 optometrists to option 2.

Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage, however, you will only be compensated for your time if you complete both the questionnaire and fundus image grading exercise.

Your decision on whether to take part or not to take part, or to take part and then withdraw, will not affect your relationship with CERA.

We cannot guarantee or promise that you will receive any benefits from this research, however possible benefits may include assisting in the development of a clinical auditing tool for standardizing glaucomatous optic neuropathy (GON) detection in optometry settings, which has the potential to improve the care of your patients.

AHPRA registered Optometrists who participate in this project will receive a gift voucher following verification of AHPRA registration and completion of the questionnaire and fundus image grading exercise. The value of the gift card will be dependent on the time commitment of study participation. Those who participate in option 1 (~ 40 minutes time commitment) will receive a gift voucher to the value of $100 and those who participate in option 2 (~3 hour time commitment) will receive a gift voucher to the value of $300. Again, please note, you can only participate in option 1 or option 2, but not both.

There are no direct risks to you as a clinician.

Sometimes during the course of a research project, new information becomes available about the technology that is being studied. If this happens, the research team will inform you and discuss with you whether you want to continue in the research project. If you decide to withdraw, the research team will make arrangements. If you decide to continue in the research project, you will be asked to sign an updated consent form.

Participation in any research project is voluntary. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage. If you decide to withdraw from the project, please notify a member of the research team before you withdraw. A member of the research team will inform you if there are any special requirements linked to withdrawing.

If you do withdraw your consent during the research project, the research team will not collect additional personal information from you, although personal information already collected will be retained to ensure that the results of the research project can be measured properly and to comply with law. You should be aware that data collected by the researcher up to the time you withdraw will form part of the research project results.  If you do not want them to do this, you must tell them before you join the research project.

This research project may be stopped unexpectedly for a variety of reasons however these are unlikely. These may include illness and sudden disaster.

Participants may request to be informed via their preferred form of contact of the final results when the research project is complete and the data is published. The results may also be discussed at academic conferences. Also, media release, progress reports and associated newsletters will be accessible to all participants online.

By completing the questionnaire and grading exercise, you consent to the research team collecting and using personal information about you for the research project. Any information obtained in connection with this research project that can identify you will remain confidential. We will protect the anonymity of you and your patients, as well as the confidentiality of your consultations. All records taken as a part of this study will remain confidential. Any information supplied and data collected will be kept in a password protected computer or in locked facilities in the Centre for Eye Research Australia (CERA). Your name or your patients’ names will not appear in any publications or reports arising from this study, and if needed you will be referred to by a pseudonym. We will remove any references to personal information that might allow someone to guess your identity. Your data may be shared with collaborators nationally and internationally for future research. Prior to sharing, any information that can identify you will be removed. Only deidentified data will be shared.

In accordance with relevant Australian and Victoria privacy and other relevant laws, you have the right to request access to the information collected and stored by the research team about you. You also have the right to request that any information with which you disagree be corrected. Please contact the research team member named at the end of this document if you would like to access your information.

Any information obtained for the purpose of this research project and for the future research described in Section 14 that can identify you will be treated as confidential and securely stored.  It will be disclosed only with your permission, or as required by law.

After study completion, data will be archived for at least 7 years in a secured, on-premises server at CERA.

If you suffer any injuries or complications as a result of this research project, you should contact the study team as soon as possible and you will be assisted.

This research is conducted by the Principal Investigator, A/Prof. Peter van Wijngaarden from the Centre for Eye Research Australia.

This research has been funded by the Medical Research Future Fund.

CERA may benefit financially from this research project if, for example, the project assists CERA to obtain approval for new AI software.

You will be compensated for your time with a gift card as described above. Other than the gift card you will not benefit financially from your involvement in this research project even if, for example, your results (or knowledge acquired from analysis of your image grading) prove to be of commercial value to the CERA. In addition, if knowledge acquired through this research leads to discoveries that are of commercial value to the CERA, the research team or their institutions, there will be no financial benefit to you or your family from these discoveries. CERA will receive a payment from the Medical Research Future Fund for undertaking this research project. No member of the research team will receive a personal financial benefit from your involvement in this research project (other than their ordinary wages).

All research in Australia involving humans are reviewed by an independent group of people called a Human Research Ethics Committee (HREC).  The ethical aspects of this research project have been approved by the HREC of St Vincent’s Hospital Melbourne.

This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies.

Should you require any further information, or have any concerns, please contact Principal Investigator (peterv@unimelb.edu.au) or any of the following people:

Clinical contact person

All complaints will be treated confidentially. In any correspondence please provide the name of the research team or the name or ethics ID number of the research project. If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general which you do not wish to discuss with the research team, then you may contact:

Complaints Contact Person 

Reviewing HREC approving this research and HREC Executive Officer details

By proceeding, you agree that you have read the above information and voluntarily agree to participate.