Eye and Ear Human Research Ethics Committee

The IGATES study is a global, multicentre registry-based study established in early 2021.  The primary aim is to develop a large database of eye trauma cases to provide an opportunity to conduct research related to eye trauma. The project consists of two arms:

IGATES1 – a retrospective arm, where data from RVEEH patients presenting from 2016 with eye trauma will be entered into the registry. Data from a follow up period of 2 years will be included.

IGATES2 – a prospective arm, where data from RVEEH patients presenting from the time of HREC approval and commencement of this study will be included, with follow up period of 5 years for each patient.

Glaucoma is a progressive disease of the optic nerve resulting in visual field loss. Patients often present late, when much damage has already occurred. Even when presenting early, and with best ongoing medical therapy, patients’ vision will decline at a progressive rate. There are significant variations in this rate; some patients will decline very slowly, however others on the same therapy can reach poor vision and blindness much more quickly. Identifying these ‘fast progressors’ before they decline will be advantageous to a) be able to treat them more aggressively from the outset, and b) use them in neuroprotective trials in order to decrease the time and number of participants required. Previous ‘predictive’ models in glaucoma have been poor, however they have often used methods of statistical analyses known to be less accurate. This study aims to identify fast progressors in the glaucoma unit at RVEEH as well as a private clinic in Melbourne. Subsequently, this paper will analyse the population prevalence of these fast progressors, and other characteristics including baseline measurements at initial presentation, underlying factors that may be associated with fast progression, and response to surgical in these patients compared to their ‘normal progression’ counterparts. This work will form the background to and impetus for future studies into fast progressors, aiming to ultimately be able to pick these patients from the outset to improve both their specific treatment, and the efficiency of neuroprotective trials, which will improve the treatment of all people with glaucoma.

The aim of the project is to assess the effect of switching patients with age-related macular degeneration from certain older eye injection drugs (anti-VEGF) to a newer injection called high dose aflibercept. We will mainly be looking at how frequently the patient had injections before and after this switch. We will also be looking at the quality of their vision and the state of disease at the back of their eye as measured on an OCT scan. We will perform this by looking at the data of patients who have already undergone all injections at a retina specialist clinic. All patient data will be kept confidential. We will be using real-world data to determine if results of previous trials actually correlate into clinical practice.

This research project will contain four sub-studies, as outlined below:

Understanding the current referral process through a retrospective audit of RVEEH outpatient files

1. How many patients with ERM have been referred and seen in this new “long waiter” clinic?
2. Were the referrals appropriate (i.e., requiring surgery, symptomatic patients, etc.)?
3. How long did they wait to be seen?
4. What was the surgical turnover (%)?
5. How many patients declined surgery, and documented reason(s)?

Patients’ experience survey

1. Create a survey that assesses patient journey from their optometrists’ visit to surgery (if completed), to identify gaps and opportunities to improve communication and empower patients.
2. Retrospective data collection for patients already treated at the RVEEH
3. Prospective survey for incoming RVEEH patients, to identify gaps in their knowledge of their condition and treatment options

Develop a patient resource to enhance patient awareness of ERM, their symptoms, and possible interventions.

1. This will contain key resources for patients to understand their condition and possible treatment processes.

Designing a standardised referral pathway from primary eye care providers to the RVEEH

1. The results from the retrospective audit and patient experience survey will help in the design of a standardised, evidence-based referral pathway for optometrists and primary eye care providers.
2. This resource will contain clear guidelines on what information needs in the referral to the RVEEH (i.e., symptoms, vision, imaging)
3. It will contain information for patients (#3 project) and timelines for referrals to the RVEEH.

The data collected in the above four projects will allow us to identify areas to improve patient management with ERMs and allow us to generate improved frameworks in the future.

To investigate the effect of intraoperative steroids on structural and functional visual outcomes for patients undergoing combined cataract surgery, pars plana vitrectomy (PPV) + epiretinal membrane (ERM) peel for idiopathic ERM (iERM). We hypothesise that those undergoing surgery for iERM who receive intraoperative steroid, either (i) subtenons triamcinolone (STTA) or (ii) intravitreal Ozurdex (DEX), will have improved structural and functional visual outcomes. This retrospective registry analysis will be a prelude to a randomised-controlled trial (RCT) investigating the effect of intraoperative steroid use on structural and functional visual outcomes after combined cataract surgery, PPV + ERM peel for iERM. While some vitreoretinal surgeons do routinely give intraoperative steroid in ERM/ILM peel (either subtenons triamcinolone or intravitreal Ozurdex), there is current no accepted standard of practice. With the role of inflammation in ERM formation currently unclear, and the relatively sparse existing data for intraoperative steroid use for combined cataract surgery, PPV + ERM/ILM peel, this remains a relatively evidence-free zone. The results of this retrospective review will be essential to plan and design a subsequent randomised clinical trial on the use of intraoperative steroid medication in iERM surgery.

This pilot project aims to explore the potential for extracting features from OCTA images useful for the diagnosis and management of glaucoma.  Optical Coherence Tomography Angiography (OCTA) is a new form of imaging that in some ophthalmology collect a set of images from eyes with and without glaucoma, perform texture analysis on the images and to explore any differences between eyes with and without glaucoma.  We will prospectively collect the control eyes and some of the glaucoma eyes and request a waiver of consent to be able to analyse existing scans in our database from eyes with glaucoma. The analysis will form part of the research project for a BMedSc honours student.

Thyroid eye disease (TED) is an autoimmune disorder related to the activation of autoantibodies against thyroid stimulating hormone receptors, and can result in enlargement of fatty tissue, extraocular muscles, and connective tissue within the orbit. TED may be associated with an increase in intraocular pressure (IOP), likely secondary to an increase in the episcleral venous pressure, although other mechanisms have been proposed. Consequently, TED has the potential to contribute to glaucomatous optic neuropathy (GON) if untreated, potentially resulting in irreversible visual loss.

For this study, a retrospective clinical audit will be performed on TED patients at the Royal Victorian Eye and Ear Hospital (RVEEH) who have undergone orbital decompression surgery (ODS) to understand the impact of the surgery on IOP and glaucoma. Data at the time of surgical consent, first post-operative visit, and 3- and 6-month post-operative visits will be captured, alongside the data from the surgery itself. This data is captured on a TED Assessment Record: Orthoptist Follow-Up form (TED Assessment Record) which includes IOP and number of glaucoma medications. This will enable quantitative measurement of the impact of ODS on IOP and IOP control (measured in the change in IOP lowering medications [active ingredients] used). A subgroup analysis will be performed in individuals with TED and concomitant glaucoma undergoing ODS.

In these patients, optical coherence tomography (OCT) and Humphrey Visual Field (HVF) data will also be recorded to evaluate glaucoma progression. Fundamentally, this study will enable reporting the impact of ODS on IOP in individuals with TED. This will facilitate a costbenefit analysis of ODS in the control of GON and ocular hypertension (OHT) in TED patients and has the potential to influence current surgical guidelines and practices, improve glaucoma management in patients with TED, and enhance cost-effective healthcare delivery.

Retinal artery macroaneurysms (RAMs) consist of outpouchings of branch retinal artery walls weakened by arteriosclerosis. They are strongly associated with advancing age and systemic hypertension. Treatments for unruptured aneurysms include observation, focal laser photocoagulation, and more recently, intravitreal Anti-VEGF. The latter has had extremely good results in improving visual acuity and central retinal thickness. A known complication of RAMs is macular oedema, similar to that seen in diabetic retinopathy or retinal vein occlusion, which can itself cause visual impairment. The mechanism of this is thought to be due to extravasated fluid from the RAM migrating to the subretinal space and traveling to the macula from its origin. We describe herein a case series of conical macular detachments in patients from Geelong, Victoria, with known retinal artery macroaneurysms. Whilst OCT findings of patients with RAM, including macular oedema, have been described, we believe our finding of a starkly dome-shaped macular detachment, distant from the RAM itself, to be unique. Given its association with RAM in our case series, we aim to describe the characteristics of our findings and the patient population, in order to utilise our descriptor as a method of identifying or predicting RAMs in the future.

Thyroid eye disease (TED) is a complex, immune-mediated inflammatory condition that can follow a variable clinical course, including periods of reactivation after apparent quiescence. While initial risk factors for TED are well described, less is known about the patterns, timing, and potential triggers of reactivation.

This retrospective study aims to characterise reactivation in TED by examining clinical records from patients treated by three Ophthalmology Consultants that work at Royal Victorian Eye and Ear Hospital. Key parameters to be analysed include timing of reactivation, potential precipitating factors (e.g. smoking status, thyroid function changes, recent illness or procedures), and demographics.

Patient involvement will be limited to analysis of existing medical records.

No direct contact with patients will occur. Eligible participants will include those diagnosed with TED who have received treatment or follow-up under the care of the

three participating clinicians over the past 6 years. Data will be extracted for this sole purpose and analysed securely. The findings from this study may help clarify risk profiles for TED reactivation, inform follow-up strategies, and guide patient counselling on modifiable triggers, potentially contributing to improved long-term outcomes and resource planning in ophthalmic care.

This study aims to investigate the management of paediatric cochlear implant candidates with potentially useable hearing pre-implant at the RVEEH through a retrospective case review of paediatric cochlear implant cases from 2015 to 2024.

This retrospective study will review data from Descemet Stripping Automated Endothelial Keratoplasty (DSAEK) surgery performed at the Royal Victorian Eye and Ear Hospital between 2021-2023. The aim of the study is to determine the effect of graft factors on post-operative clinical outcomes. We will collect data on graft thickness, endothelial cell density, storage media, and microkeratome system used in graft preparation. We will then complete a chart review of patient outcomes:best corrected visual acuity, corneal clarity andthickness, and need for further surgery. We will also collect information on confounding variables, namely patients’ previous ocular history and baseline visual acuity, in order to more accurately determine the effect of surgery. Our results may help inform surgical practice and lead to improved outcomes for future patients.

The goal is to develop and validate a deep learning model to predict POAG progression by analysing a single baseline OCT scan to predict future changes in the VF. The model will be trained using baseline OCT scans, alongside baseline and latest 24-2 VF data. The model is most likely a CNN and will learn to correlate structural patterns in the OCT (e.g RNFL thinning) with future VF changes by training on pairs of baseline OCT scans and VF progression changes between the baseline and latest VF reports. The model will predict the probability of POAG progression, classifying patients into either: Progressing or Stable/Non-progressing. This is a binary classification model designed to aid early clinical decision-making and risk stratification. If time permits, we will compare the CNN’s performance with a Support Vector Machine (SVM) machine learning model and/or incorporate progression rates from Guided Progression Analysis (GPA) into the model to enhance prediction accuracy.

Thyroid Eye Disease (TED) is an autoimmune condition that causes inflammation around the eyes. This can lead to a range of symptoms, including blurred vision, double vision, eye pain, discomfort, and bulging of the eyes (proptosis). In severe cases, TED can cause vision loss. The condition is most commonly associated with an overactive thyroid (hyperthyroidism) due to Graves’ disease and less commonly in individuals with an underactive thyroid (hypothyroidism). TED is usually diagnosed based on symptoms and an eye examination, but CT or MRI scans are particularly useful in assessing extent of extra-ocular muscles enlargement, as well as treatment response. TED can be treated with both medications and surgery according to phases of disease, but treatment approaches differ worldwide. In the United States, the only approved drug for TED is Teprotumumab, a targeted antibody therapy given as an infusion. In Australia and many other countries, the first-line treatment is currently intravenous (IV) corticosteroids, in the form of pulsed Methylprednisolone. Currently, there are no direct studies comparing these two treatments. This research aims to provide more information on the radiological effects of IV corticosteroids on soft tissues around the eyes and extra-ocular muscles, which will help in future comparisons between steroid treatment and Teprotumumab. This is a retrospective longitudinal imaging study, looking at existing patient records from 2016 to 2024. Patients will not be required to undergo any new treatments or interventions. The study will analyse medical imaging scans (CT or MRI) taken at baseline before treatment and 12 months after IV steroid treatment. To conduct this analysis, the scan will be de-identified and uploaded onto The Orbital Radiology Center (TORC, Los Angeles, C.A, USA) MIMICS image repository. The patented three-dimensional image analysis software will then be used to assess three key factors: proptosis (eye bulging), orbital fat volume, and extraocular muscle volume. Comparisons may then be drawn between a patient’s pre and post IV methylprednisolone treatment scans to determine the changes to orbital soft tissues.  Volumetric analysis will be blinded to the assessor and validated by two co-investigators.

The study aims to evaluate volumetric changes in the orbit pre and post- intravenous corticosteroid in TED, to objectively determine radiological changes in moderate to severe TED cases following medical treatment.

Cataract surgery is increasingly becoming a refractive procedure, the aim is not only to replace the patient’s cloudy lens with a new clear intraocular lens (IOL) and achieve good vision with glasses but provide superior vision without glasses.   This is achieved by minimizing post operative refractive astigmatism (the amount of astigmatism when a patient is assessed for glasses).  If the post operative refractive astigmatism is low, glasses aren’t required.  Toric IOLs reduce astigmatism.  There is good evidence they work for high astigmatism.  The evidence they work for low astigmatism isn’t as strong, particularly low with the rule corneal astigmatism. The proposed study will shed light on factors affecting outcomes for patients with low with the rule corneal astigmatism.

Chronic retinal conditions such as diabetic retinopathy and age-related macula degeneration require timely access to treatments such as laser and intra-vitreal injections in order to prevent permanent visual loss. Referrals to the Royal Victorian Eye and Ear Hospital Medical Retina Unit (EMR) are currently made via e-fax with (at most) a single slice B scan OCT image. We aim to investigate whether access to a cloud-based full cube OCT scan will improve triage efficiency and accuracy by both correctly diagnosing retinal pathology and secondly reducing the number of urgent referrals required to be seen in the clinic.

This project aims to understand why some patients unexpectedly lose vision after the removal of a special type of silicone oil used during retinal surgery.  Silicone oil is often used as a temporary support inside the eye to help the retina heal after surgery for a condition called rhegmatogenous retinal detachment (RRD).  In more complex cases, a heavier type of oil – called heavy silicone oil (HSO), such as Densiron® – may be used.

While HSO is effective in keeping the retina attached, some patients experience unexplained visual loss after the oil is removed, even though the retina looks anatomically normal. The exact cause of this vision loss is unclear, and this can be very distressing for patients and challenging for surgeons.  Understanding how common this complication is, and whether certain factors make it more likely to happen, will help guide future surgical decisions and improve how we inform patients before surgery.

This is a retrospective study, meaning we will only review existing medical records and eye scans of patients who have already had retinal surgery with HSO or conventional silicone oil at our hospital.  No contact with patients is required, and no new procedures or tests will be performed.  We will include patients who had successful retinal reattachment surgery using oil, and who later had the oil removed.

We will collect information such as age, gender, vision before and after surgery, details of the operation, and the results of retinal scans (OCTs).  We will compare the rate of unexplained visual loss between patients who had HSO and those who had regular silicone oil.  We will also look for pattens on the eye scans that may explain these visual changes.

All patient data will be anonymised and handled securely.  The results of this study may help us reduce the risk of visual loss in future patients and lead to better counselling and decision-making for those needing retinal surgery.

This project will explore the effectiveness of antiviral prophylaxis in managing viral eye infections, focusing on the recurrence rates of HED and VED after treatment with valaciclovir, as well as trends in antiviral resistance over time. To achieve these aims, we will review existing EMR records of patients diagnosed with HED and VED at RVEEH, alongside pharmacy dispensing records of valaciclovir. Findings from this study may help guide effective use of antiviral prophylaxis, identify patients at higher risk of recurrence or resistance, and ultimately improve long-term clinical outcomes.