Evaluation of ocular microstructural changes due to ultraviolet radiation

What is the purpose of this research?

The aim of this project is to improve the understanding of ultraviolet (UV) associated changes in the cells on the eyelids and the front surface of the eye.

Are you looking for people like me?

Adults aged 18 - 70 years with:

• healthy ocular surface OR
• Pterygium OR
• surgically removed eyelid lesions.

A screening assessment will be conducted to assess your suitability to participate in study during the initial visit after consent.

What will you ask me to do?

If you are suitable to be enrolled in the study, and if you belong to group 1 (people with healthy eyes), your participation will involve one initial visit (duration: ~60 minutes) in winter and a follow-up visit in summer (duration: ~60 minutes). Additionally, people with healthy eyes, will be undergoing 2 follow-up visits, each lasting 30 minutes (on same day of the baseline evaluation), to evaluate daily UV exposure across a day in winter and summer. This will help us to assess ocular surface changes due to acute UV exposure (1 day follow up) and seasonal UV change (3 months follow up).

If you belong to group 2 (UV-ocular disease group), your participation will involve one visit only.

Baseline or initial visit: At the initial visit we will evaluate the health of the front surface of your eyes as normally performed during a routine eye examination.  A small amount of yellow dye (sodium fluorescein) will be used to evaluate any dryness on the front of the eye. You will be asked some questions about past sun exposure and symptoms of ocular irritation. We will also examine the cells on the surface of your eyes using an imaging device called a confocal microscope. To do this we will install an eye drop (2-4 drops) to numb the eye. We will also conduct conjunctival imaging, which is a contactless photography of the eye, to provide information on ocular surface UV damage. A small quantity of tears will be collected from your eyes using a small tube without touching the surface of the eye for tear analysis.

1 day follow up in winter and summer: Some of the people with healthy eyes will be asked to wear a UV sensor for 1 day to measure UV exposure levels in winter and summer and at the end of this day, these participants will be asked to return for re-assessment of the front of the eye, as well as the conjunctival and confocal imaging.

3 months follow up: All individuals with healthy eyes will be asked to return for a final follow up after 3 months for a repeat of the baseline assessments.

If you are enrolled in group 2 (UV ocular diseases group) of the study, information about the date, and type of the eyelid lesion that was removed will be sought from your treating ophthalmologist. All assessments will take place in Anterior Eye Laboratory, Q-Block, QUT Kelvin Grove campus.

Are there any risks for me in taking part?

What risks are involved?

1. In vivo confocal microscopy: Imaging of the ocular surface using this microscope may lead to minimal rubbing of the front surface of the eye, like that which might occur if you physically rub the eyes, for example in response to minor irritation when there is an eyelash in your eye. However, this type of rubbing heals quickly without intervention, typically within 12 hours. The part of the instrument that contacts the eye (tomocaps) are single use and disposable.
2. Anaesthetic drops (numbing agent): The drops can cause transient stinging which disappears within 2 min. Use of this agent can cause very mild sensitive reactions. You will be asked if you have ever had an allergic reaction to it before; if so, you won't be able to take part in the study.
3. Fluorescein dye: There is a very remote potential to have an allergic or adverse reaction to sodium fluoresceine, but this is very low as fluorescence is a water-soluble inert stain (an agent mixed with saline that is used to assess staining of the ocular surface). You will be asked if you have ever had allergic reaction with use of this material, if so, you won't be able to take part in the study.
4. Tear collection: An unpreserved saline will be instilled without touching the eye and you will be asked to close the eyes for 5 secs and to bend towards the shoulder side, a microcapillary tube will be placed on the lower eyelid region on the temporal area and tears will be collected without touching the ocular surface using a tube. During tear collection you will only feel minimal discomfort, or it may result in mild redness and slight irritation at the corner of the eye, which should resolve a few minutes after the procedure.

An examination of your eyes before and after the test will be performed to check for the ocular surface integrity. In the rare instance of damage being noted at the end of the procedures, you will be immediately discontinued from the study and the licensed optometrist or ophthalmologist who is a part of the research team will provide appropriate intervention for ocular adverse effects.

Are there any benefits for me in taking part?

It is expected that this research project will not benefit you directly. However, the outcomes of the research will result in better understanding of ultraviolet associated cellular changes on the eyes and around the eyes (eyelids). During the study, the investigator will share any information regarding the measurements of your eyes that may be of interest to you.

Will I be compensated for my time?

To thank-you for your participation, the research team will provide you with gift a card (Woolworths or Coles) value of $20 after completing your involvement. Free parking will be organised ahead of time if required.

I am interested - what should I do next?

If you are interested in participating in this study, please contact Ishwarya Suresh Kumar via email ishwarya.sureshkumar@hdr.qut.edu.au You will be provided with further information to ensure that your decision and consent to participate is fully informed. Please note that this study has been approved by the QUT Human Research Ethics Committee (approval number 8269).