Help us understand tear biomarkers in Traumatic Brain Injury (TBI)

What is the research study about?

You are invited to take part in this research study. The research study aims to investigate the manifestation of traumatic brain injury (TBI) on specific proteins in the tear film and on the parameters of corneal nerves and the behaviour of corneal immune cells.

Who is conducting this research?

The study is being carried out by the following researchers: Emeritus Professor Eric Papas, A/Prof Maria Markoulli, Dr Jerome Ozkan, Dr Sultan Alotaibi, Dr Azadeh Tavakkolinasab and Zewdu Bizuneh, School of Optometry and Vision Science, UNSW. Sydney.

Research Funder: This research is not receiving funds.

Inclusion/Exclusion Criteria

Before you decide to participate in this research study, we need to ensure that it is ok for you to take part. The research study is looking to recruit people who meet the following criteria:

For Healthy controls:

• Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Be aged over 18 years with no previous head injury or neurological disorders.
• Have ocular health findings considered normal
• Non-symptomatic as quantified by Rivermead post-concussion syndrome questionnaire.

For participants with TBI:

• Be aged over 18 years and diagnosed with TBI in the last 12 months.
• Or a former sports player with a history of TBI.
• Be able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent.
• Participants who give consent to provide information about the TBI severity indices.

Participants who meet the following criteria will be excluded from the study:

Exclusion criteria for those who are not eligible to participate as healthy controls and participants with TBI in the study include:

• On ocular or neurological medications.
• Taking oral or topical doxycycline or corticosteroids.
• Be currently enrolled in another clinical trial or have participated in a clinical trial within the previous 2 weeks.
• Pregnant or lactating
• Neurodegenerative disease
• Current eye or brain surgery

Do I have to take part in this research study?

Participation in this research study is voluntary. If you do not want 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 study at any stage.

If you decide you want to take part in the research study, you will be asked to:

• Read the information carefully (ask questions if necessary);
• Sign and return the consent form if you decide to participate in the study;
• Take a copy of this form with you to keep.
• The research team advises participants with TBI to come with a friend or family member for their support.

What does participation in this research require, and are there any risks involved?

If you agree to participate, you will be asked to attend three visits, at each visit you will be asked to complete the following research procedures:

Screening:

First: Questionnaires:  We will ask you to complete two questionnaires: One is about dry eye symptoms and the other is about the severity of symptoms of the post-head injury. This should take approximately 10 minutes to complete.

Second: Information regards the head injury: We will ask you to provide the severity indices during the head injury, including the Glasgow Coma Scale score, the duration of loss of consciousness, time of recovery, and score of Rivermead post-concussion syndrome questionnaire. This information is critical to help us to define the category of the head injury.

Third: Vision check: A standard letter chart will be used to check your vision. There is no risk with this procedure and it will take less than 5 minutes.

If you meet the criteria, sample collection will be conducted, and this includes the following tests:

First: Slit-lamp biomicroscopy: We will examine the surface of your eyes using a slit-lamp biomicroscope. This is an instrument consisting of a magnifier and light, which is routinely used in optometric practice and will be used to assess your eye health. The light may be bright but will not cause any harm to your eye and will take less than 5 minutes for both eyes.

Second: Tears collection: Tears will be collected using well-established method that involves a fine glass capillary tube (microcapillary tube) with a smooth tip. Prior to collection, a small volume of sterile saline (approximately one drop) will be added to your eye to aid tear collection and minimise any irritation. Following the addition of saline to your eye, the microcapillary tube will be held at the outer edge of your eyelid and will not contact your eye. Tear collection may result in mild redness and slight irritation at the corner of the eye, which should resolve a few minutes after the procedure, the collection will take one minute for each eye.

Third: Confocal microscopy imaging:  A special type of microscope called a confocal microscope will be used to study corneal nerve distribution and the presence of corneal inflammatory cells. A probe that emits a harmless laser light will come in contact with the transparent front part of the eye for no more than 5 minutes. A topical anaesthetic drop will be applied before the test to avoid any discomfort. The integrity of the eye will be checked after the procedure. The procedure will take 15 minutes for both eyes.

Fourth: Ocular surface stains: Vital dye will be used to assess the integrity of the eye surface after the procedure. There is no discomfort associated with this procedure and it will take 5 minutes for both eyes.

Additional Costs and Reimbursement: There are no costs associated with participating in this research project, nor will you be paid.

Psychological Distress: You may feel that some parts of the procedure is stressful or upsetting. If you do not wish to continue that, you may stop immediately. If you become upset or distressed as a result of your participation in the research project, the research team will be able to arrange for counselling or other appropriate support. Alternatively, a number of free contactable support services are included at section 9.  Any counselling or support will be provided by qualified staff who are not members of the research team. This counselling will be provided free of charge.

Support Services Contact Details

If at any stage during the study, you become distressed or require additional support from someone not involved in the research please call:

What are the possible benefits of taking part?

We cannot guarantee or promise that you will receive any benefits from this research; however, your participation in this project may help the specialists to understand the manifestation of TBI and its impact on the eye surface, which may help to improve the quality of the provided health care which reflects on patients with TBI.

What will happen to information about me?

By signing the consent form, you consent to the research team collecting and using information about you for the research study.

The research team will store the data collected from you for this research project for:

• A minimum of 7 years after the completion of the research.

The individual identifiers will be removed from the stored data using the following method: The name, address, and date of birth identifiers will be removed during the transcription process. Identifying information will be replaced with numbers.

• Information collected from you in an electronic format stored on a UNSW password protected OneDrive only accessible to the approved research investigators.
• Information collected from you using paper-based measures will be stored in locked cupboard in the North Wing of the Rupert Myers Building at UNSW, in room 3.058 and only the approved research investigators will have access to this information.

The information you provide is personal information for the purposes of the Privacy and Personal Information Protection Act 1998 (NSW).  You have the right of access to personal information held about you by the University, the right to request correction and amendment of it, and the right to make a complaint about a breach of the Information Protection Principles as contained in the PPIP Act.  Further information on how the University protects personal information is available in the UNSW Privacy Management Plan.

How and when will I find out what the results of the research study are?

The research team intend to publish and/ report the results of the research. All Information will be published in a way that will not identify you. If you would like to receive a copy of the results you can let the research team know by inserting your email or mailing address in the consent form. We will only use these details to send you the results of the research.

What if I want to withdraw from the research study?

If you do consent to participate, you may withdraw at any time. You can do so by completing the ‘Withdrawal of Consent Form’ which is provided at the end of this document or you can ring the research team and tell them you no longer want to participate. Your decision not to participate or to withdraw from the study will not affect your relationship with UNSW Sydney or any of the organisations involved in this research.  If you decide to leave the research study, the researchers will not collect additional information from you. You can request that any identifiable information about you be withdrawn from the research project.

What if I have a complaint or any concerns about the research study and will I receive compensation if suffer any injuries or have complications?

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 with arranging appropriate medical treatment. If you are eligible for Medicare, you can receive any medical treatment required to treat the injury or complication, free of charge, as a public patient in any Australian public hospital.

Complaints Contact

If you have a complaint regarding any aspect of the study or the way it is being conducted, please contact the UNSW Human Ethics Coordinator:

10. What should I do if I have further questions about my involvement in the research study?

The person you may need to contact will depend on the nature of your query. If you require further information regarding this study or if you have any problems which may be related to your involvement in the study, you can contact the following member/s of the research team:

Research Team Contact Details

Chief Investigator

Support Services Contact Details

If at any stage during the study, you become distressed or require additional support from someone not involved in the research please call:

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