Myopia dominated the clinical program at O=MEGA23 and the 4th World Congress of Optometry, but there were also many other thought-provoking sessions that Insight attended.
In a small breakout room in the depths of the Melbourne Convention and Exhibition Centre, one of the most lively discussions took place at the O=MEGA23 conference. There, Melbourne optometrist Mr Jim Papas was presenting on a new TGA-approved myopia management intervention from Australian-based firm Eyerising International.
Papas is the director of clinical optometry for the company that has developed a therapy based on repeated low-level red-light (RLRL) technology in the treatment of myopia. The treatment emits low level single wavelength red light, increasing blood flow and metabolism causing re-thickening of the choroidal layer, thereby helping slow elongation of axial length.
Being a new approach to myopia that effectively stimulates the body’s own healing mechanisms – and recently receiving regulatory clearance in Australia (aas well as in Europe, New Zealand, Malaysia) – it’s no surprise that myopia authorities like Dr Kate and Dr Paul Gifford were in attendance to hear what the company had to say. Also of significance is the statement that Eyerising’s device has been shown to have up to 87.7% treatment efficacy in patients with high compliance in one study.
Papas presented alongside Dr Nellie Deen, from the Australian College of Optometry (ACO), where RLRL is being investigated in a clinical study in Australia. All up, five clinical trials are also under way globally, and a sixth (a multicentre, real world clinical evaluation in the EU) is planned.
RLRL is an exciting development in the myopia field. The Giffords, as well as optometrists from the ACO, had many questions for the company. A lively discussion took place about its mechanism of action, safety and rebound effects which Papas and Mr Paul Cooke, CEO of Eyerising, engaged with by explaining the technology and highlighting studies supporting RLRL in myopia management.
Specifically, Eyerising presented information showing more than 150,000 children have undergone RLRL therapy, with nearly 80,000 daily users in China. As reported by its Original Equipment Manufacturer (OEM) side-effect reporting centre, only five out of the 80,000 users in China have reported severe adverse events (1:20,000). Importantly, none of these were severe and all recovered.
“This is exactly what these sessions are about,” O=MEGA23 organiser and Optical Distributors and Manufacturers Association (ODMA) CEO Ms Amanda Trotman told Insight.
“It’s a forum to hear directly from researchers and industry, and drill down into topics with back-and-forth discussions. And for anyone who is launching a product, it’s an opportunity for them to hear feedback or what the concerns may be, so they can work to address them on the spot and through their marketing.”
The debate was robust and indicative of a conference where myopia took centre stage in the clinical program.
Prof Peter Hendicott – Global optometry update
This year’s O=MEGA23 was held with the 4th World Congress of Optometry. This meant there were around 200 overseas attendees, including some high profile figures.
Early on delegates were given an update on the World Health Organization’s World Report on Vision and its relevance to optometry. This was delivered by outgoing WCO president Professor Peter Hendicott, an Australian, who posed many thought-provoking questions about what future role optometry will play to address eye health inequalities globally.
Major challenges that lie ahead, he said, including ensuring optometry has the relevant competences to broaden its scope and maximise its participation in health delivery.
“The challenge that gets put to optometry when we increase our scope is that patient safety will be adversely affected,” he said. “We need evidence, through research and clinical pathway development trials, that when optometry is involved in health systems in a different way, that it’s effective, it’s safe, outcomes are improved through early detection, and costs are reduced.”
He said the WHO and UN had highlighted the lack of human resources, but given it takes five to seven years to train an optometrist and 15 years for an ophthalmologist, the industry needs to think of smarter ways to utilise the practitioners it already has.
“We need to look at how optometry can work and deliver eyecare effectively with others, in an eyecare pathway that is continuous. We need to think about how we can use technologies, devices, artificial intelligence, and the rest, to improve access,” he said.
Dr Susan Cotter – Flipping the script on uncorrected hyperopia
Dr Susan Cotter, one of two keynote speakers of the conference and president of the American Academy of Optometry, kicked off her session by renaming the lecture live on-stage from ‘Can correction of refractive error change a child’s life trajectory?’ – as listed in the program – to ‘Can correction of hyperopia change a child’s life trajectory?’.
“I was afraid that if people knew I was talking about hyperopia, instead of myopia, they wouldn’t want to come,” she quipped.
Hyperopia in children has been a relatively neglected field, but Cotter found comments from as far back as the 1970s calling for eyecare professionals to take more notice.
She told an anecdote of a six-year-old patient named Diane who couldn’t complete school assignments, was disruptive in the classroom, and had a short attention span. After prescribing spectacles to correct her moderate hyperopia, one month later Cotter received a call from Diane’s teacher describing the U-turn in the young girl’s behaviour and academic performance.
“It makes you wonder what would have happened if Diane never visited the optometrist. If she doesn’t learn to read, she doesn’t do well in subjects, now she doesn’t like school, maybe she drops out of high school, and she doesn’t go on to university. The trickle-down effect can be profoundly life-altering; it can influence not only educational performance but also career prospects and future earning potential,” she said.
Cotter demonstrated prevalence rates of hyperopia, with one US population-based study showing rates between 15-20% in children under the age of six. Collated data from population-based studies in the US, Singapore, and Sydney showed the prevalence of more than +2.00D of hyperopia was 21% in 4-year-olds.
“And if they didn’t have amblyopia or strabismus, the majority of them were not wearing an optical correction,” she added.
With this in mind, Cotter cited a Queensland University of Technology study showing the condition’s impact on reading performance, especially when it came to comprehension. Other researchers also showed increased reading speed when hyperopia was corrected.
Her favourite study was by the Vision in Preschoolers-Hyperopia in Preschoolers (VIP-HIP) Study Group who compared four- and five-year-olds with +3.00D to +6.00D of uncorrected hyperopia, with age-matched emmetropic children from the same schools. They found significantly worse visual function in the uncorrected moderate hyperopia group, as well as deficits in sustained attention, visual perception, as well as visual motor integration. Importantly, on literacy tests, those with moderate uncorrected hyperopia did significantly worse.
“So, can correction of moderate hyperopia change a young child’s life trajectory? I think it can,” Cotter said. “We certainly have evidence pointing in that direction and it’s up to us as optometrists who are seeing children to be on the look out and pay special attention to these children who might benefit from optical correction.”
Professor James Wolffsohn – The power of consensus
The answer is 17 years, but what is the question? This was how Professor James Wolffsohn captured the attention of delegates with his presentation showing how consensus reports are developed and how they can be utilised to elevate clinical practice.
The question was: what is the time lag in the translation of research into clinical practice? Noting this is a long time, he addressed the conflict between clinical intuition and the need for standardisation based on research evidence.
“If that was your cancer, would you want someone using techniques that were developed 17 years ago?,” said Wolffsohn, the second keynote speaker and Professor of Optometry at Aston University in the UK.
When it comes to the term “evidence-based practice”, he said three components matter. The clinician first needs to consider the patient’s own preferences, and then build in their own clinical experience and available research evidence.
Highlighting inconsistencies in the industry, he used the example of dry eye diagnosis.
One 2017 survey involving 1,139 practitioners showed the median number of tests – such as verbal symptoms, fluorescein breakup time, corneal staining – was seven, but some practitioners were performing as many as 28.
“It just can’t be like that in clinical practice because if perform 28 tests then no one would ever get diagnosed,” he said.
Also in 2017, the TFOS DEWS II reports were published that considered the research and clinical application of dry eye tests and came up with a simple way for practices to diagnose the disease.
Wolffsohn said the DEWS reports were consensus documents that led the way for drawing out the latest evidence-based literature and turning it into something to be applied in clinical practice. Other major clinical summaries have also emerged like the International Myopia Institute white papers, and the CLEAR reports from the British Contact Lens Association.
“I find these to be useful reference documents. I’m not going to learn all of it, but sometimes a patient will ask me about scleral lenses and dry eye and I can dip into these resources and say this is the evidence we’ve got, and why we might go ahead with this approach or not,” he said.
“And of course, there are other professionals such as GPs and pharmacists who are dealing with people who report symptoms of dry eye, so by having a consensus amongst ourselves as optometrists, that helps other professions understand their role.”
Dr Noel Brennan – A new ‘breakthrough’ contact lens for myopia
In one a well-attended session, Australian scientist and inventor Dr Noel Brennan, a fellow for Johnson & Johnson Vision, provided insight into a “breakthrough” soft contact lens for myopia control the company has developed.
At the heart of this lens design is the application of “non-coaxial optics” that he said “breaks the nexus” between efficacy and vision experienced in current designs that have originated from presbyopia correction principles and adopted a ‘near-add’ focus.
Traditionally, he said contact lens developers have had three knobs they can tweak to strike the balance between efficacy and vision, namely changing the power in the treatment zone, changing the size of the treatment zone and changing the location of the treatment zone.
“And so we are looking to find a fourth knob to help us break away from that interrelationship we currently see between efficacy and vision,” he said.
In developing J&J’s prototype lens, Brennan said the company joined forces with Professor Michael Collins, from the School of Optometry and Vision Science at the Queensland University of Technology, who has developed a special apparatus that incorporated a spatial light modulator. This allows contact lens developers to test optical designs in a much more efficient manner than previously.
Another crucial element is the use of axial length and choroidal thickness to inform the lens design. It was later suggested that lenslets – much like those found in myopia control spectacle lenses – could be incorporated. Brennan and his team asked the QUT team to put a design incorporating this into its spatial light modulator.
“And they said sure, but would you’d like that with coaxial optics or non-coaxial optics? And we said, ‘say what?’.”
The QUT team went on to explain how the contact lenses could bring light to a point focus, or it can be done with individual axes.
“And being the good little scientists that we are, we said, ‘let’s try both’, and the results are rather stunning,” Brennan added.
During the presentation, he then pulled up a slide showing that both methods showed a reduction in axial length, but when it came to vision and contrast the non-coaxial design performed better.
This has formed the basis of the new lens and is the fourth knob that can be turned to advance myopia control soft contact lenses. Brennan said the prototype represents many firsts in soft contact lens myopia control.
“We built this from the ground up. It’s the first time a soft contact lens has been made for myopia control not based on presbyopia principles per se. We used the novel apparatus for the first time to enable systematic concept optimisation and iterative refinement of individual lens designs,” he said.
“For the first time, we’ve applied non-coaxial optics in contact lenses to break this nexus between efficacy and vision. And for the first time, we’ve used rotationally symmetric portion of a torus, rather than a sphere, for myopia control treatment. We achieved FDA device breakthrough designation, we’ve validated the design concept through clinical trials with an excellent balance between efficacy and vision … and the resulting lenses meet all the desired properties for paediatric myopia control.”
Dr Kate and Dr Paul Gifford – Unanswered questions in myopia
Myopia was the headline act on the second day of the clinical conference, so it was perhaps fitted that homegrown husband-and-wife myopia experts Dr Kate and Dr Paul Gifford, from Myopia Profile, initiated proceedings.
The topic: unanswered questions in myopia and, more specifically, looking at the “meaty topic” of the most efficacious interventions, with the value placed on axial length data and how practitioners can interpret results from studies.
Kate explained three different ways that practitioners can understand efficacy: millimetres, treatments that are going to save 1.00D, and percentages.
In terms of millimetres – treatments that have shown an absolute reduction of axial growth by at least 0.1mm/year (a measure that moves the myopic eye closer to emmetropic eye growth) – she said new myopia controlling spectacles like HOYA’s MiYOSMART and Essilor Stellest have met this criteria, alongside dual focus contact lenses like CooperVision’s MiSight 1 day, the aforementioned J&J non-coaxial ring focus contact lens design, orthokeratology (orthok), atropine (1.0%, 0.05% and 0.025%), and red light-based therapy.
On the measure of saving 1.00D (approximately 0.25mm axial length equivalent), Kate explained this was particularly important because it has been shown that saving 1.00D reduces a patient’s lifelong risk of pathology, myopic macular degeneration in particular, by around 40%. New spectacle lens designs again met this criteria along with dual focus, non-coaxial ring focus contact lenses and orthok. Red light did too, along with atropine 1.0% and 0.05%, she said.
Interestingly, she showed how three treatment modalities slowed axial length by 0.21mm, 0.15mm and 0.11mm compared to the control group, alongside their respective diopters savings, 0.54D, 0.40 and 0.23D.
“You’ll note how the diopters vary wildly compared to the millimetres, and that speaks to why millimetres are our better measure when it comes to research studies to compare between treatments; diopters are blunter measurement instruments,” she said.
Kate said it was positive to see so many interventions achieve these treatment effects after two or three years of trial data. It begs the question, however, whether more than 1.00D can be saved? This can likely be achieved however a major barrier is that after two to three years when a treatment is showing effect in a study, it becomes unethical to keep progressing myopes in the control group. A way the industry has responded is through advanced modelling and, through this, it’s been shown children could save more than 2.00D with a childhood of MiSight 1 day contact lens wear.
“It means we’re getting that benefit of reducing myopic maculopathy by 40% and then another 40%, if we can save 2.00D. And research presented this year on the Stellest lens showed that it’s likely on a similar trend,” she said.
Kate also addressed the tricky issue of percentages. She said it was important to avoid comparing percentages across studies because each number belonged to that trial only. Instead, she recommended grouping them into categories: treatments that can slow progression by 50% or more (or “by at least half”), for example.
“That’s a simple message to parents to say we can’t stop progression, but we can slow it down. We then have interventions [on the second tier], which have shown in their studies of various durations, to slow progression by about a third. Now that might have been 32% or 37%, but about a third. And then we have minimally effective interventions in third place.”
In summing up, Paul said most treatments with at least 12 months of trial data show similar efficacy, with various options showing they can slow progression by at least a half. With no treatment showing clear superiority, he said the practitioner has options.
“You’re left with prescribing anything other than a single vision lenses, which we know is not a good approach, with a treatment that suits the child and fits your scope-of-practice. Also, by prescribing optical treatments we’re able to offer the dual benefit of treatment and vision correction, with an important factor here being full time wear,” he said.
Kate said highly compliant children had achieved excellent results in studies, but some questions remain when it comes to comparing treatments.
“We know that we have efficacy of a wide variety of treatments, we know there appears to be a dose response to atropine and we’re learning about different formulations. There doesn’t appear to be rebound effects with optical treatments, but there are with higher concentrations of atropine and with red light therapy,” she said.
“We’re still learning about how we can best describe efficacy and compare treatments from the research and a scientific perspective, whether that’s an absolute or a proportional effect. We’re also still learning about how long we should treat for and when we’re going to get the best treatment, and the influence ethnicity may or may not have on efficacy.”
Dr Joe Paul – Myopia prevalence in Australia
Dr Joe Paul, head of professional services at Specsavers ANZ, provided the latest update on myopia prevalence rates as experienced by the company’s practices in Australia and New Zealand.
He said there had been few large scale studies across the region, and various prevalence estimates have emerged from works such as the Sydney Myopia Study, SAVES study and Australia and New Zealand Child Myopia Report.
“Unfortunately, there’s very little in the way of the hard data for either of these countries,” he said.
This was the impetus for Specsavers to gauge prevalence by performing a retrospective review from 2017-2022 of all children (under 16) visiting its practices across ANZ. Out of more than three million patient records, the company identified more than 460,000 myopic children, as per their spherical equivalent refraction calculated from their script.
In Australia, Specsavers found a general upwards trend of prevalence among children presenting to optometrists, increasing from 24.6% to 27.8% over the five-year period. The figures also showed the average age children are first diagnosed is also decreasing, from 14.6 years in 2017 to 13.3 years in 2022. And when looking at high myopes (greater than -6.00D), Paul showed this has increased to 3.5% in 2022.
Next, Specsavers was keen to extrapolate its findings comparing Medicare billing against ABS population data for each state to estimate prevalence across the total population in under 16 years. In this data, the estimated prevalence was 24.9% in Victoria (the highest), 20.8% in Western Australia and 10.5% in Northern Territory (the lowest).
“On average, across the country, we estimate the population prevalence of myopia among kids is 19.7%, which would mean that there’s approximately a million myopic kids in Australia. This is a chance for Australia to lead the world with a large population of kids and we are setting the standard for myopia management,” he said.
“I don’t want to say this is necessarily a definitive value, it is an estimate based on Medicare billing and the ABS data and the patients we’re seeing at our practices, but it is perhaps the first national estimate of prevalence of myopia in Australia.
“Our prevalence estimate is higher than what has been reported in previous epidemiological studies, but slightly lower than the Australasia mark in Holden et al’s seminal paper and less than some surveys that have been done. Myopia’s perhaps not increasing quite as rapidly as it could be, but it is certainly on the rise.”