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Home Soapbox

The Australian Save Sight registries

by Staff Writer
February 8, 2021
in Feature, Soapbox
Reading Time: 5 mins read
A A
Professor Mark Gillies played a key role in the research of MacTel and development of an implant to treat it. Image: Mark Gillies.

Professor Mark Gillies played a key role in the research of MacTel and development of an implant to treat it. Image: Mark Gillies.

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When people ask me how on Earth I decided to be an eye doctor I have to admit my father was one. I had never intended to do what he did and I thought I had ignored all his advice. When he told me that ‘observational’ (a.k.a. ‘Phase 4’ or ‘post-marketing’) studies were needed to show that treatments identified by randomised clinical trials (RCTs) actually worked in routine clinical practice, I thought he was just trying to boost his publication list. It turns out that I was wrong about that too.

I have come to believe that conducting observational research is one of the fastest and most cost-effective ways to improve treatment outcomes for patients at scale.

RCTs became the sine qua non for registration of a medical intervention last century. They show whether a treatment actually works under ideal conditions but not necessarily whether it will work when the average Joyce attends her doctor in ‘real-world’ clinical practice.

Clinical trials do not represent the general population, they tend to include otherwise healthy people, which many of our patients aren’t, and they may ‘enrich’ the study population to get the desired result. For example, many studies of injections for macular diseases have an upper limit on visual acuity (VA) so there is room for improvement when the primary outcome is VA gain.

As a result, there are extremely limited data from RCTs on the benefit of treating eyes with neovascular macular degeneration (nAMD) with visual acuity better than 6/9, even though this is exactly when we would like to start treating them. Conversely, analysis of RCT outcomes led the UK’s National Institute for Health and Care Excellence to limit treatment for diabetic macular oedema to eyes with >400 microns central macular thickness, excluding a large number of patients with thickness between 300-400 microns no matter how bad their vision is.

My friend Nigel Morlet explained the idea behind observational research as our feet dangled from the wharf one year at RANZCO in Hobart. The exponential growth of technology means eventually all ‘pseudanonymised’ information from patients will be extracted from the system, analysed and fed back in to change things for the better. This change can in turn be verified and further improvements made. It sounded simple and any technical understanding of IT whatsoever did not seem to be a prerequisite to embarking on a career of observational research.

We founded the Fight Retinal Blindness! (FRB!) Treatment outcomes registry with support from the RANZCO Eye Foundation in 2008 to track the outcomes of bevacizumab (Avastin), which everyone was using on the basis of very few data.

We were fortunate to have started in Australia, where several factors make it an ideal environment for achieving good nAMD outcomes: general recognition of AMD is amongst the highest in the world, the drugs are reimbursed without restrictions, practitioners are paid adequately for the procedure and most practitioners use the ‘Treat and Extend’ regimen that has been found to be the most efficient way to deliver an adequate number of treatments.

We provided amongst the first real-world data on the induction and maintenance phases of treatment of nAMD, the relative efficacy of the available agents and 10-year outcomes which has helped establish Treat and Extend as the most widely used regimen internationally. Data are coming out of the FRB! diabetic macular oedema and retinal vein occlusion modules that suggest there is room for improvement in treating these diseases.

We have developed other modules to study outcomes of treatments for other eye diseases, some of which had very limited supporting data. Fight Glaucoma Blindness! is amassing large amounts of data on stents, while Fight Corneal Blindness! (FCB!) is publishing outcomes for keratoconus. FCB! is the first module to include data from optometrists. Ideally the system will ultimately track, analyse and report outcomes data from all professionals looking after eyes, not least the patients through ‘patient-reported outcomes’. Modules to track outcomes regarding ocular melanoma, inherited retinal degenerations and retinopathy of prematurity (Fight Baby Blindness!) are under development.

It’s worth keeping an eye on observational research because its primary interest is the actual outcomes of your patients. Participation, e.g. by joining one of the Save Sight Registries modules, allows practitioners to compare their patient’s outcomes with national benchmarks. This is a relatively easy way to achieve what we want: the best outcomes for our patients despite the constraints of the system in which we work.

ABOUT THE AUTHOR:

Name: Professor Mark Gillies
Qualifications (in abbreviations): MB BS, PhD, FRANZCO
Business: Save Sight Institute, University of Sydney; Eye Associates
Position: Director of Research
Location: Sydney
Years in the profession: 30

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Tags: Fight Corneal Blindness!Fight Retinal Blindness!neovascular macular degenerationobservational studiesophthalmologypost-marketingProfessor Mark Gilliesrandomised clinical trialsreal worldregistrySave Sight InstituteSave Sight Keratoconus RegistryUniversity of Sydney

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