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There are defined circumstances under which researcher may use tissue or data without first obtaining consent from the individuals involved. This is termed a waiver of consent.

The Health Records Act (2001) stipulates that a waiver of consent can only be granted by a fully constituted Human Research Ethics Committee.

Furthermore, a waiver can only be granted if sufficient justification is provided in line with Chapter 2.3 of the National Statement on Ethical Conduct in Human Research.

The Health Records Act (2001) also stipulates that

the name of all projects operating with a waiver of consent must be publicly available.

To comply with this legislative requirement, the following table contains a list of projects that are currently being conducted at The Royal Victorian Eye and Ear Hospital using a waiver of consent:

The National Statement also requires that

2.3.12 Given the importance of maintaining public confidence in the research process, it is the responsibility of each institution to make publicly accessible (for example in annual reports) summary descriptions of all its research projects for which consent has been waived under paragraphs 2.3.10 and 2.3.11.

To comply with this requirement a summary of the project is listed below:

Project Title

HREC Approval Date

22/1535HL: Uveal Melanoma Biopsy – Surgical Complications and Diagnostic Accuracy

The purpose of this audit is to analyse the surgical complications and diagnostic accuracy of biopsies taken at the time of uveal melanoma treatment. The results of these tests help us to estimate how likely a tumour is to spread outside the eye, which, in the case of uveal melanoma, is almost always fatal. This biopsy technique is used widely overseas and was started at the Royal Victorian Ear Hospital in 2017. The RVEEH is the only centre in Australia to perform it routinely. This audit will compare both the rates and types of surgical complications, as well as the rate of obtaining an accurate result from the biopsies. These will be compared with international benchmarks.

9 Jun 2022
21/1514HL: International Globe and Adnexal Trauma Epidemiology Study (IGATES)

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.

4 Jan 2022
14/1164H/19-002b: Maximising speech perception benefits in hearing aid users – Quantify the relationships between different speech perception and questionnaire evaluations in hearing aid users from new and retrospective data – Comparison and Combination of Online Hearing Tests Study

The proposed retrospective data study will use the results of the online hearing tests and clinical test for 1000 clients of Sonova Audiological Care Australia. This is a very low risk study that will improve understanding of the accuracy, strengths and weaknesses of online hearing tests, and is likely to improve the accuracy of
online hearing testing, which will improve online screening for hearing loss, the appropriate provision of hearing health services, and remote fitting of hearing devices for a wide population of Australia and the world.

21 Dec 2021
21/1504HL: Comparison Between Zeiss Optical Biometry and Traditional Topography Measurements of Anterior Segment Parameters

Patients considered for cataract surgery with IOL-master k>2.5 routinely underwent corneal topography imaging. We review the reliability of the Seiss IOL-master topography module compared to traditional corneal topography for detecting keratoconus. This will be a retrospective review of 200 recent patient outpatient images from the surgical ophthalmology service.

1 Dec 2021
21/1517HL: Fundus Infrared Reflectance in ophthalmology

Infra-red reflectance (IRR) images of the retina are routinely captured whilst taking optical coherence tomography (OCT) images. The IRR images were designed to act as a map indicating showing the location of the cross sectional OCT. However IRR images contain significant clinical information that can help guide diagnosis and management. This project aims to review the utility of IRR images.

9 Nov 2021
21/1516HL: Characterisation of fencing wire related penetrating eye injuries

The aims of this study are to describe cases of penetrating eye injuries due to fencing wire. Our study will summarise cases that have presented to our institution and report epidemiological data so that ophthalmologists can be well informed about the common characteristics of this mechanism of injury. Single centre, retrospective review investigating diagnostic error in the context of penetrating eye injuries.

26 Oct 2021
21/1502HL: A retrospective analysis of temporal artery biopsies in giant cell arteritis at the Royal Victorian Eye and Ear Hospital

Aims
1.         To identify the distribution of positive, negative, and equivocal results for giant cell arteritis in all temporal artery biopsies
2.         To analyse the clinical features associated with a positive temporal artery biopsy
3.         To identify alternative diagnoses in patients for patients with negative and equivocal temporal artery biopsies
Methodology
Retrospective, single centre, electronic record chart review of patients from the Royal Victorian Eye and Ear Hospital (RVEEH) who have had a temporal artery biopsy (TAB) from 2015 to 2021. The sensitivity and specificity of the clinical and biochemical values will be determined. Furthermore, the clinical and biochemical data will be used to determine the likelihood of a positive temporal artery biopsy through logistic regression analyses.
20 Jul 2021
21/1494HL: Diagnostic error in penetrating eye injuries and ruptured globes

This is a single centre, retrospective review aimed to describe cases of penetrating eye injuries or ruptured globe where there was initially a misdiagnosis or delay in diagnosis. We will collate de-identified data from patient records including patient demographics, mechanism of injury, presenting symptoms, details of injury (laterality, anatomy involved), clinical pathway (location of presentation, initial diagnosis, details of correct diagnosis), time of injury to correct diagnosis, past ocular history, details of investigations (B scan, computer tomography scan), management, complications and status at final follow up.

Inclusion criteria are cases of penetrating eye injuries or ruptured globe that presented to the Royal Victorian Eye and Ear hospital and were managed by the general ophthalmology unit with initial misdiagnosis or delay in diagnosis.

We propose to summarise findings and suggest solutions to improve diagnostic accuracy for prospective patients.

16 Jun 2021
21/1496HL: Rates of Glaucoma Progression in a Novel Population

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.

11 May 2021
20/1477HL: Radiological Eustachian tube morphology as a predicting factor for chronic otitis media

Middle ear function has been known to be affected by Eustachian tube anatomy and function. The angle and length of Eustachian tubes have been measured in greater detail recently with increased accuracy of computed tomography (CT). These measurements may have implications on the risk of chronic otitis media.

28 Oct 2020
20/1475HL: Treatment outcomes of patients with Vogt-Koyanagi-Harada Disease

This is a retrospective audit of patients with a diagnosis of Vogt-Koyanagi-Harada (VKH) disease, who attended the Royal and Victorian Eye and Ear Hospital Ocular Immunology Clinic between 2004 and 2019.
The primary objective is to describe the clinical characteristics, treatment regimens and clinical outcomes of patients with Vogt-Koyanagi-Harada disease at the RVEEH. The effect of the route of administration of corticosteroids on clinical outcomes in VKH disease, as well as the effect of early immunomodulatory therapy on clinical outcomes in VKH disease, will be evaluated.

13 Aug 2020
20/1464HL: Use of Intracameral Triamcinolone Acetonide at the time of Uveitic Cataract Surgery

The departmental database of patients with uveitis who have undergone cataract surgery will be audited to identify patients who have received intracameral triamcinolone acetonide at the time of their uveitic cataract surgery. Hospital records will be used to collect deidentified data on perioperative variables and clinical outcomes of patients who received intracameral triamcinolone and will be compared to to patients with uveitis who received other forms of uveitis treatment/
prophylaxis at the time of their surgery. Deidentified data will be collated.

The primary objectives of this retrospective study are to 1) determine the safety of intracameral triamcinolone acetonide administered in uveitic cataract surgery, 2) evaluate the efficacy of intracameral triamcinolone acetonide in reducing postoperative inflammation in uveitic cataract surgery and 3) evaluate the association between intraoperative intracameral triamcinolone acetonide and visual outcomes in patients with uveitis. The secondary objective is to inform a future consensus on the use of intracameral triamcinolone in uveitic intraocular procedures.

18 Jun 2020
20/1466HL: Risk factors of cerebral vasculitis in acute posterior multifocal placoid pigment epitheliopathy

Retrospective review of patient files to try and identify risk factors that portend a higher risk of cerebral vasculitis in patient’s suffering from acute posterior multifocal placoid pigment epitheliopathy. Data to be collected will include: patient demographics, clinical examination findings, treatment, and investigations (blood tests and imaging).

18 Jun 2020
19/1450HL: Changes in glaucoma referral rates

This project is a retrospective audit of data collected from approximately 3.5 million patient encounters per year at Specsavers Pty Ltd. The focus of the project will be to investigate changes in glaucoma referral rates of optometrists since the introduction of the Royal Australian and New Zealand College of Ophthalmologists (RANZCO) referral pathway and Ocular Coherence Tomography (OCT) imaging in all stores. The aim is to produce manuscripts to be published in high level peer-reviewed journals.

15 Jan 2020
19/1447HL: Improving SSNHL drug trial design using statistical modelling of observed patient data

Sudden sensorineural hearing loss (SSNHL) occurs when the hearing in one or both ears is lost suddenly, for no apparent reason.  At the Eye and Ear’s ED Department we see these patients frequently.  Many therapies have been suggested, trialled, and routinely practiced. Despite this investment of effort and resources, the cause remains poorly understood and the optimal treatment remains contentious.

This project seeks to understand the behaviour of hearing loss, and its occasional recovery, so to better inform the design of future clinical trials.   Clinical trials need to be optimised to arrive at realistic cohorts of participants, while managing the risks variability introduced by the natural history, or the possibility that there may be non-responders to the drug.  To achieve these goals we have used the hearing results of our patients to model various “what-ifs” that may occur during a clinical trial.  In this way, we have been able to work out how many patients are required to participate in a clinical trial for a robust result to be seen.  We have been able to determine how many patients would be required to see varying degrees of hearing improvement, and varying rates of response to the drug.  This work in is preparation for publication, as it will act as a guide for future clinical trials to treat this distressing condition.

9 Dec 2019
19/1449HL: Outcomes of cataract surgery in patients with a previous diagnosis of scleritis

The existing departmental database of scleritis patients will be cross referenced with the SOS database to identify scleritis patients that have undergone cataract surgery. Hospital records will be used to complete a proforma for each patient on their surgical outcome and data collated.

5 Dec 2019
19/1427HL: Use of Artificial Intelligence to Predict Outcome of Full-Thickness Macular Hole Surgery

This project will test the predictive power of an artificial intelligence (AI) system to determine the likelihood of success or failure of macular hole surgery, based on a pre-operative optical coherence tomography (OCT) scan of the macular hole. The project will utilise a pre-existing and ongoing registry of macular hole surgery outcomes in Australia, and will involved a preliminary period of collecting pre-operative anonymised macular OCT scans (for which the registry has ethics approval to collect).
The OCT scans and binary surgical outcome data, e.g. hole closure success or failure, will be used by the AI system during a ‘learning’ phase. Basic demographic data from the registry may also be used e.g. patient age, gender and visual acuity. A subset of OCT scans will be reserved to then test the predictive power of the AI system. The system may then be ready for testing against experience vitreoretinal surgeons. Our research could provide clinicians with a new and novel tool to complement surgical planning and patient consent.

6 Jun 2019
19/1416HL: Review of optic nerve sheath fenestrations: indications and outcomes

To determine and compare the efficacy and safety of optic nerve sheath fenestration (ONSF) for idiopathic intracranial hypertension (IIH) and indications other than idiopathic intracranial hypertension from 2002 to 2019.

5 Apr 2019
19/1412HL: The effect of surgery on the course of herpetic eye disease, with variable antiviral prophylaxis

Uveitis from herpetic infection is the major cause of infectious anterior uveitis in both developing and developed countries. It may occur in association with or without keratitis. Other manifestation like posterior uveitis, panuveitis, or acute retinal necrosis (ARN) may occur. Herpes simplex virus (HSV) affected patients were more likely to have a recurrent course of uveitis than varicella zoster virus (VZV) patients, who tended to have a chronic disease with more posterior pole complications. The difference in the disease course and visual outcome in these groups of patients  post-intraocular surgery is a question that is to be answered in this study.

21 Feb 2019
19/1414HL: A Multicentre Study of Behcet’s Uveitis: Clinical Presentation, Treatment and Ocular Outcomes

Behcet’s disease (BD) is a chronic recurrent inflammatory disorder of unknown origin.  It  is characterised  by oral ulcers, genital  ulcers and uveitis (inflammation  inside the  eye).  Uveitis  occurs in up to 80% of cases and is often persistent with episodes of severe exacerbations with high rates of blinding ocular complications.

Despite the established importance of Behcet’s uveitis, there is still a paucity of data in the literature regarding  the expected  disease  duration of Behcet’s  uveitis and whether shorter  times to remission or quiescence can be influenced  by the  overall clinical BD phenotype, severity of uveitis at presentation and treatment paradigms used –  and  whether  any  of these are associated  with improved visual outcomes.

Such knowledge will provide  both patients  and doctors an indication  of how  long patients with Behcet’s uveitis should be expected to require immunosuppressive treatment. In addition, such information will also help guide the treatment  of these  patients  with  such  blinding  disease, particularly with respect to the recent introduction of biologics such as adalimumab, a TNF alpha inhibitor. Other than the recent use of  biologics,  reasons such as lifestyle or environmental  factors were also proposed in the recent reports that described a trend towards milder disease since the year 2000. Thus, we will also perform a comparison of visual outcomes and disease duration between BD patients who were treated before and after the year 2000 in our respective institutions.

Therefore, the purpose of this study is to address these knowledge gaps through conducting a retrospective chart analysis of Royal Victorian Eye and Ear Hospital and Selayang Hospital patients with Behcet’s disease.

20 Feb  2019