HREC Waiver of Consent projects

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.

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.

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.