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Spotlight

Carl Zeiss Case Studies

High-Frequency Deep Sclerotomy A MIGS Procedure for Mild-to-Moderate Glaucoma

iCare COMPASS Automated Perimeter

Clinical

1rem

The findings have potential clinical and public health implications and highlight the greater role of metabolic health status than obesity in IOP elevation, according to the authors.


Weighing the link among metabolic health, obesity and IOP

The procedure can provide prolonged IOP lowering in primary open-angle glaucoma with an excellent safety profile.

Canaloplasty: Putting together a complete surgical picture

Automated AI tool offers offline capability and hope for patients.

Smartphone-based fundus camera puts glaucoma screening in the palm of clinician hands

Examining the anatomy and physiology may prevent ineffective stent implantation.

Understanding Schlemm canal to improve the results of stent surgery

Thurein Htoo, MS, MBA, CEO and co-founder of Qlaris Bio, took the podium at the New Horizons Forum at the Glaucoma 360 conference in San Francisco to discuss the performance of the company’s episcleral venous pressure eyedrop, QLS-111. 

Glaucoma 360: Eyedrop targets and reduces episcleral venous pressure in glaucoma

 This transcript has been lightly edited for clarity.

 Hi, this is Sean O'Neil, Chief Commercial Officer of ViaLase. Excited to be at the Eyecelerator meeting at AAO and provide an update on ViaLase milestones.

ViaLase is a medical device company, it's venture backed, out of Southern California. We are focused on disrupting the current conventional glaucoma treatment paradigm with the introduction of a non-invasive, image-guided femtosecond laser to address primary open angle glaucoma.

The leadership team has a vast experience in femtosecond lasers, designing, manufacturing, commercializing, the first femtosecond laser for both refractive as well as cataract and now looking to take that knowledge and leverage it within the glaucoma marketplace.

I'm excited to announce that the founder and CEO Dr. Tibor Juhasz was recently awarded the 2022 Golden Goose Award in recognition of his and his fellow researchers, finding that femtosecond lasers can make corneal incisions with high precision without damaging adjacent tissues, which revolutionized the LASIK marketplace. And we look forward to ViaLase taking that experience and recreating it and that success for glaucoma patients.

As we know with glaucoma, glaucoma treatment paradigm is typically driven by a trade-off thought process. If you want more efficacy, you typically have to give up safety. We're designing our technology to bring those into balance. And the technology is designed to create a femtosecond laser, image-guided, high-precision trabeculotomy, what we're calling the FLigHT treatment.

The FLigHT treatment again is is to include OCT-driven femtosecond laser delivery for safety and efficacy but also with an intuitive learning curve, so that is accessible to all surgeons, glaucoma specialist and cataract surgeons alike. And we're we're also working on a business model so that there is value for all stakeholders.

We're excited to provide here, at AAO Eyecelerator, a case series of data to assess safety and efficacy of an 18 patient case series non-washed-out, so real-world out to 24 months. 24 months is important in glaucoma because you want that long-term data to assess both safety as well as durability of treatment.

Of the patients in the cohort out to 24 months, they demonstrated a 31% IOP reduction and also excited to say that 100% of them achieved the 20% or greater IOP reduction, all with a very safe profile.

This data is very encouraging and we look forward to demonstrating our results in a multicenter, randomized controlled trial that is currently ongoing. Finally we are in the process of getting CE mark and we're also preparing for our submission to the FDA for 510K clearance and look forward to keeping you updated on those milestones as we prepare for commercialization.

Videos

Shawn O'Neil of ViaLase shares updates on the company's femtosecond laser, image-guided, high-precision trabeculotomy (FLigHT) treatment.

Video Series

Expert Interviews

Disrupting the glaucoma treatment paradigm with novel femtosecond laser from ViaLase

This transcript has been lightly edited for clarity.

 Hi, I'm Dr. Mitch Shultz from Los Angeles, California, and I'm here to talk to you a little bit today about the study that I've done on the iStent inject versus the Hydrus stent.

We've actually been looking now we're getting close to presenting 2-year data on this study where we implanted patients, contralateral eyes, 1 eye with iStent inject and 1 eye with Hydrus and have followed the patients prospectively over the last 2 years.

The interesting thing that's come out of this data has really been that both products work extremely well as far as target IOPs. Both products have achieved a significant reduction in patient eye drop load but we found in patients who are implanted with either stent with just the implants, they typically get off approximately 1 medication. What has been interesting is in combination with ab interno canaloplasty, we have actually been able to improve that to 1 and a half to 2 medication reduction in medication burden.
Another important fact has been the fact that 80% of patients have are now medication-free. So that's been another feature of the study.

But what has really been critical and what's really kind of changed. The way I'm doing things today is the fact that we have less adverse events in our iStent group than we've had in the Hydrus group. So what we've seen in the iStent group is zero intraoperative adverse events and zero postoperative adverse events.

Unfortunately, in the Hydrus group, there are some learning curve problems that surgeons may experience with underimplantations, overimplantations, or missing the passage and going into the superciliary space, which can lead to other problems postoperatively. We've actually seen one patient with angle closure glaucoma occur after Hydrus stent.

So I think when we're looking for safety, efficacy, iStent inject has really stood out in this group, even though both stents work very well. So thank you very much, and I look forward to seeing you around the meeting.

At AAO 2022, Dr Mitch Shultz provides discourse on iStent inject vs Hydrus contralateral eye evaluation data.

2-year data in contralateral eye evaluation gives edge to iStent inject over Hydrus stent

It's great to see you. I know you presented yesterday on quality of life—yesterday afternoon. Could you tell me a bit more about the key takeaway points from your presentation?

 Yeah, so I'm a glaucoma specialist, and a cataract surgeon. And nowadays with advances in glaucoma surgery, there's a new type of glaucoma surgery that most ophthalmologists are familiar with called minimally invasive glaucoma surgery. And this is surgery that can be very easily and fits perfectly well when it's combined with cataract surgery.

 So, at the same time, as a patient having a cataract surgery, we can now do operations to better control or optimize their glaucoma.
I've been doing this for at least the last 10 years now. And what I've noticed—certainly in the last few years, as we're doing higher volumes of these patients—is that when patients come back to their post-op visit, the next day or one week later, you can see a big transformation in the patients. They are seeing better, so they're happy. The eye pressures are better controlled, they're taking less glaucoma medications, and they just feel less anxious about glaucoma.

Glaucoma is the leading cause of irreversible sight loss in the world. And a lot of patients worry about this in between the clinic visits, glaucoma can dominate their lives. And you see that once their pressures are better controlled, and you sort of told them their glaucoma is stable, that really allays a lot of their anxiety.

Then you've got the other patients, big group of patients, majority of patients that hate taking their drops. You know, imagine if you have to put drops twice a day for the rest of your life. That can isolate you, can limit your social interactions with others, and again, creates that insular approach that "I have a stigma of a disease or chronic disease."

 And they sort of dissociate themselves from society. So getting patients off glaucoma drops then frees them from that. So they have that sort of physical independence from not being on the drops. But on the other side, their eyes are a lot more comfortable.

Glaucoma drops are effective, or they can make the eyes red, sore, itchy, watery. So we've looked at a study essentially, as opposed to just seeing patients in the clinic, actually doing a study to look at patient-reported outcome measures, using some well-established patient reported outcome measures such as the glaucoma severity scale, glaucoma quality of life, the ocular surface disease index.

So we looked at all the these both before the surgery, four months after the surgery, and just recently 12 months after surgery. And we see a big improvement from before the surgery to four months. And that improvement has been maintained at 12 months.

 So and then when we examine their eyes, we look at the surface of the eyes, look at how healthy their tear film is, how healthy their eyes are in general. And that also has shown a big improvement.

So you know, it's nice to have post-op patients that are happy. They're—happy patients make happy doctors. And really, of course, glaucoma is about controlling the eye pressure, about preventing further visual field loss and keeping patients from visual disability in their lifetime.

But if patients are happier, more confident, less anxious, and have a better quality of life, then that's a that's a huge—

 A win-win. And it's something that probably as clinicians we underestimate, and hopefully these kinds of studies will help make it more commonplace to sort of start off thinking as there's a patient at the end of that eyeball.

 So one step towards that. Lots of more work to do. But yeah, very happy with the initial results.

What would be the next steps for this research?

So the next step would be to apply it to other glaucoma surgeries and not just the minimally invasive glaucoma surgeries but some of the bigger surgeries that we need to do for patients who are a little bit more advanced or the glaucoma is a bit more aggressive, and maybe potentially looking at at other types of surgery as well.

We know some stuff about cataract surgery, but you know, retinal surgery, and those sorts of things, so not just limited to glaucoma. And then within our own data, we've got 12-month data, but it'd be lovely to see whether this is maintained at two years, three years and five years. They're the next steps, really.

Yes. Oh, that sounds really good. Well, thank you very much for sharing your insights with Ophthalmology Times Europe.

Mr Gokulan Ratnarajan recaps his 2022 ESCRS presentation: "A Real World Comparison Of iStent Combined With Phacoemulsification And Endocyclophotocoagulation (Ice2) With Preserflo And Xen-45 Implants In The UK; Short- And Long-Term Outcomes."

Should endocyclophotocoagulation be considered part of MIGS? Mr Ratnarajan delves in

 Thank you for joining me today, Dr Lubeck, to discuss your presentation on endothelial cells, which I understand you just gave, in fact. It's lovely to meet you here in sunny Milan. I'm Caroline, editor of Ophthalmology Times Europe. Could you please tell me more about your presentation and what the key takeaway points were?

Caroline, we and surgeons who have done MIGs surgery have been drawn more and more to the possible consequences of damaging corneal epithelium as we do our procedures. There's much still to be learned about how these procedures affect the epithelium over the long term.

Canaloplasty, which is procedure I've been doing for about seven years, there was little to no data on its effect on the endothelial. Two years ago, Robert Noecker and I began a prospective study to determine the effects of canaloplasty on the cornea...

We found very, very strongly that canaloplasty has no negative impact on the corneal epithelium compared to cataract surgery alone. So essentially, it has minimal impact to no impact on the health of the cornea.

 Where do you see this research going in the future?

We hope to extend the current study up to 5 years, but we've also embarked on a much bigger data registry project called the iTrack Glaucoma [Global] Data Registry. It's being housed in the ISGR, the National Glaucoma Surgery Registry. And we hope to enrol up to 1,000 patients in that over a fairly short period of time, and then have a much more comprehensive look at knowing the efficacy, safety profiles and the nuanced elements of the procedure.

 It sounds like it will be really valuable data when that comes through.

It's essential. We don't have for this procedure. We don't have a single, large database, and it's been around for a long time.

 Well is anything else you would like to add, anything you're really excited about at present? Or have we covered everything?

The procedure is attractive in the beginning because it's non-destructive, there's no stents left behind. And from a Bayesian standpoint, or reasoning, it makes sense in terms of what it does for glaucoma, and the treatment. It has tremendous implications for the future.

Once we understand not only the biomechanics, but the bio-physiology of glaucoma, I believe that this technology is going to have a future application to different modalities of treatment.

 Oh really? Oh, that sounds excellent. Well, thank you very much for your insights today, Dr Lubeck.

It's a pleasure. Thank you very much, Caroline.

Dr David Lubeck talks with Caroline Richards of Ophthalmology Times Europe about his ESCRS presentations, touching on surgical effects on corneal epithelium and the iTrack Global Registry for glaucoma.

Investigating the effects of canaloplasty on corneal epithelium

Dr Ayellet Segrè presented her work on trying to understand the biological causes and cell types that lead to one of the leading causes of irreversible blindness worldwide, which is primary open angle glaucoma during the 2022 ARVO annual meeting, held in Denver, Colorado.

I'm David Hutton of Ophthalmology Times. The ARVO 2022 annual meeting was held recently in Denver, and our team continues to talk to physicians who presented papers at the conference. Today, I'm joined by Dr Ayellet Segrè, who presented a paper at the event. Thank you for joining us. Tell us about your presentation.

 Thank you for having me. So I presented work on trying to understand the biological causes and cell types that lead to one of the leading causes of irreversible blindness worldwide, which is primary open angle glaucoma.

It's characterized by gradual retinal ganglion cell death that leads eventually to the degeneration of the optic nerve head and visual field loss and can lead to blindness. And the underlying causes, the genes and processes that lead to the disease, are not very well understood. So we use the approach that integrates both very large population-based genetic study that covered over 100 regions in the genome with common DNA changes associated with risk for developing primary open angle glaucoma and integrated that with additional functional genomic information that tells us about what the different DNA changes in the genome do to gene expression, and in which cell types in eye tissues both in the front and back of the eye in which cell types they're expressed. And by developing a method that integrates both genetic associations from these very large population-based studies, what we call genome wide association studies, together with gene expression in single cells both in tissues in the front of the eye, for example, the outflow pathway through which the aqueous humour flows and it's the blockage of its drainage has been thought to affect and lead to elevated intraocular pressure, which is one of the major risk factors of primary open angle glaucoma, as well as looking at expression in the back of the eye and in the optic nerve head and in the retina and the optic nerve head where the retinal ganglion cell death occurs. And by integrating both pieces of information we found we're able to uncover genes and biological processes we think may be affecting the risk for developing this form of glaucoma. And we found that a lot of the genes tend to be expressed both in the conventional and the unconventional outflow pathway, also genes associated with intraocular pressure, there's a major risk factor.

But also an interesting fact is that about 40% of patients with primary open angle glaucoma have an intraocular pressure in a normal range of pressure. And that suggests that there may also be intraocular pressure independent mechanisms that lead to the degeneration of the optic nerve. And we found that many of the genes that map to the genomic loci associated with risk for developing primary open angle glaucoma, enrich for expression in microglia cell types in the retina and around the optic nerve — so these are cell types that support the metabolic supply and structural support of the retinal ganglion cells that you know that may be affecting itself and ability to survive.

So it suggests that we did not see actually genes enriched for expression in the retinal ganglion cells themselves suggesting that, you know, thinking about in the future different developing new therapies might be important to think about targeting the neuronal support cells in addition to maintaining the health of the retinal ganglion cells.

 What’s the next step for your research?

Yeah, so the next step we're planning on kind of following up on these results, seeing if they replicate, reproduce in an independent secondary study both of single nucleus RNA sequencing of additional healthy eye tissues from from donors, as well as in an even larger population based study looking for genetic risk factors associated with primary open angle glaucoma, that looked at maybe over 10,000 additional cases, and identify now over 300 genomic loci. So we're planning on doing this analysis with an even larger set of risk factors for glaucoma together with the single cell data and see if the results stand. And we can learn more about the underlying genes and biological processes. And then down the line we're interested in, in collaborating with experimental biologists here at Mass Eye and Ear to test some of the hypotheses of what genes and pathways may be functioning in particular cell types.

 Ultimately, what can this mean for patients?

 This work suggests that there may be both what is better understood, you know, pathophysiological path that's affecting a risk of POAG through regulation of intraocular pressure, and it's suggesting certain cell types in the front of the eye, some that have been more well established, and others were suggesting particular genes. So the hope is, currently there are medications that reduce IOP but my understanding is that some patients they might not be as effective. So having maybe this knowledge of the particular genes that are perturbed and in the particular cell types might help design even better intraocular pressure reducing medications. And the other thing is a kind of uncovering the potential role for particular cell types such as the neuronal support cells in the retina and the optic nerve head. This might open a new avenue for developing drugs that will will be helping the neuro protection of the retinal ganglion cells so could open a new avenue for therapies that are for helping treat patients that develop primary open angle glaucoma. And that is not dependent on the intraocular pressure being elevated, but maybe more has to do with the sensitivity of retinal ganglion cells. But that's that's uh, you know, there's work here at Mass Eye and Ear and trying to study the genetic predisposition to what we call normal tension glaucoma.

Presented at ARVO 2022, research from Mass Eye and Ear hopes to open a new avenue for therapies that are for helping treat patients that develop primary open angle glaucoma.

NOINDEX

NOFOLLOW

POAG study hopes to open a new avenue for therapies that are for helping treat patients that develop primary open angle glaucoma

Dr Sean Ianchulev discusses the novel robot-assisted ab interno gonio-intervention and what it means for ophthalmologists offering surgical solutions for glaucoma. This new surgical technique offers precision down to the micron level, which is more precise than a surgeon can achieve by themselves.

Dr Ianchulev is the Chief Executive Officer of Eyenovia as well as a professor of ophthalmology at New York Eye and Ear Infirmary of Mount Sinai.

This new surgical technique offers precision down to the micron level, which is more precise than a surgeon can achieve by themselves.

Gonio-intervention robot-assisted glaucoma surgical procedure offers high precision

At the 2021 American Academy of Ophthalmology annual meeting, Dr Robert J. Noecker; director of glaucoma, Ophthalmic Consultants of Connecticut, assistant clinical professor, Yale School of Medicine and clinical professor, Quinnipiac University School of Medicine; spoke with the 

team about the IRIDEX consensus paper. This paper tackles the best practices and treatment settings for the IRIDEX MicroPulse transscleral therapy for glaucoma.

 All right. So I was honoured to be a member of this consensus panel looking at MicroPulse treatment for glaucoma. And it was a consensus panel where we did a delphi method of coming to kind of best practices around treatment settings for the IRIDEX MicroPulse transscleral therapy for glaucoma. And some of the takeaway points were, in terms of the treatment parameters, is slowing down sweep speed.

So this concept of fluence which is most influenced in this treatment by sweep speed. So how quickly we move the laser probe during therapy really was one of the biggest drivers when we determine what the best way to treat or what's the best way to influence the amount of energy delivered for the therapy.

So also, we discussed optimal power settings on the laser as well as total treatment time.

So as initial settings what the consensus panel came to the best settings use or 2.5 watts, for at a sweep speed of 20 seconds per sweep. And then 80 seconds per hemisphere for a total treatment time 160 seconds. So we sweep back and forth in one hemisphere 20 seconds, go back, do that four times and then go around the top. 

And that way when we do this transscleral treatment for lowering eye pressure, we found that the side effect profile was very minimal. Many of the treating experts often don't see the patients for the first post-op week, it is a very safe therapy. Patients can really resume their lifestyles very quickly.

Also, the efficacy was maintained. So we found that the best efficacy—because historically with, with MicroPulse therapy, many early users were probably under treating a bit and that would sacrifice efficacy as well. So we found that the power settings of 2.5 watts with the slower sweep speed, both increasing total energy as well as the fluid supplied to the eye really resulted in optimal and results with this therapy.

So what this means ultimately for patients going forward is I think it really expands the range of therapy that we can use MicroPulse transscleral treatment. It gives us confidence to get good efficacy in patients with more advanced disease, where the most important thing, high pressures—we really need to lower the pressures down into the normal range again and try to reduce some of their medication load—but also in the earlier patients where they may be on a few medications but not having problems with tolerability or acquisition, but not like crazy high pressures. We can lower intraocular pressures down but also more importantly in that group, get them off of eyedrops.

So it's really expanded the utility of MicroPulse transscleral therapy for the treatment of glaucoma.

The American Academy of Ophthalmology (AAO) annual meeting was held November 12 to 15 at the Ernest N. Morial Convention Centre in New Orleans, Louisiana. The event included Subspecialty Days and a virtual component for remote participation.

Robert J. Noecker, MD, MBA, discusses the IRIDEX consensus paper regarding MicroPulse transscleral therapy for glaucoma at AAO 2021.

Investigating best practices for MicroPulse transscleral therapy for glaucoma

At the 2021 American Academy of Ophthalmology (AAO) meeting, Dr Felipe Medeiros of the Duke Eye Centre presented data on Durysta. Dr Michael R. Robinson, Vice President and Global Therapeutic Area Head of AbbVie, sits down to discuss these results.

. I'm joined today by Dr Michael Robinson, who will discuss data on Durysta, presented at the recently concluded American Academy of Ophthalmology 2021 annual meeting. Thank you for joining us today, Dr Robinson.

 Well, thank you, David. And thank you for the invitation. So I could present some of the Durysta data, talk about this at the 2021 AAO annual meeting. In glaucoma, we did present data on Durysta, which is an intracameral, biodegradable, sustained-release implant that slowly releases bimatoprost.

The first author on this abstract was Felipe Medeiros at the Duke Eye Centre. The implant was FDA approved in March of 2020 for single administration, for lowering the intraocular pressure in patients with open angle glaucoma or ocular hypertension.

The preclinical studies show drug release is complete, and intraocular tissue drug levels are undetectable by about four months after implant administration. However, in clinical trials with Durysta, the duration of IOP lowering had extended beyond the implant drug release. We presented data from an ongoing 24-month extension study of the Phase 3 ARTEMIS studies, assessing the efficacy and duration of the bimatoprost implant.

Patients in the Phase 3 trials received three implants total: one at baseline, one at four months, and then the last one at eight months, then they were followed out to 20 months total follow-up.

What we saw was that there were so many patients that had not been rescued at that 20-month time point that we needed to do an extension study to see how long the implant would actually last. They had received a 10-microgram dose, which is the marketed Durysta, or a 15-microgram dose. And we presented the pooled data in this abstract.

After the 20-month ARTEMIS study, patients then could voluntarily enrol in the extension study to look at the duration of IOP lowering beyond the length of that original study that ended at 20 months. Rescue with topical IOP lowering drops was allowed if in the opinion of the investigator of the study eye did not meet or maintain IOP expectations.

The outcome measures included the number of patients who had received no additional rescue IOP lowering treatment in the study eye for greater than two years and three years after the third implant administration in the ARTEMIS trials.

We also looked at the IOP and visual field mean deviation in the study eye of these patients. Results show that approximately 200 patients had volunteered to be enrolled in the extension study after completing an ARTEMIS trial. 69 had not been rescued yet at screening, 54 patients remained untreated for greater than two years after the third implant administration in the ARTEMIS trial, and 18 patients remained untreated for greater than three years after the third implant administration in the ARTEMIS trial.

The main baseline IOP is of these patients in these super responders were in the 23 to 24 range at the start of the ARTEMIS trials, and at the last mean IOP documented in the extension studies, the IOP was in the 16 to 17 range—off drops. The mean deviation of visual field testing of the super responder patients were stable over the past two to three years following their last implant.

So in conclusion, after their last bimatoprost implant treatment in the Phase 3 trials, patients can have a sustained IOP lowering for greater than two years, some greater than three years, without any additional treatment, and they maintained stable visual fields. The prolonged effect on IOP lowering could result from the bimatoprost stimulated upregulation of matrix metalloproteinases, leading to sustained tissue remodelling of outflow pathways. Clinical studies are in progress to further understand the duration of IOP lowering of Durysta and factors that may predict this long-term response.

At AAO, AbbVie presented results from the ARTEMIS study, showcasing IOP lowering that extends beyond the original 20-month timeframe.

Bimatoprost implant successfully lowers IOP in Phase 3 of the ARTEMIS study

 UCL Institute of Ophthalmology, London; honorary consultant ophthalmic surgeon, Moorfields Eye Hospital NHS Foundation Trust, London, speaks on how ophthalmologists can revolutionise the diagnosis and treatment of glaucoma through precision management. 

Dr Anthony Khawaja, speaks on how ophthalmologists can revolutionise the diagnosis and treatment of glaucoma through precision management. 

Precision management to revolutionise diagnosis, treatment of glaucoma

Tanner Ferguson, MD, an ophthalmology resident at the Cleveland Clinic's Cole Eye Institute, discusses findings from the study "Trabecular Micro-bypass Stent Implantation (iStent)" + Phacoemulsification in PXG: Six-Year Outcomes," during the virtual AAO 2020 meeting. 


Tanner Ferguson, MD, Cole Eye Institute, discusses findings from the study "Trabecular Micro-bypass Stent Implantation (iStent)" + Phacoemulsification in PXG: Six-Year Outcomes," during the virtual AAO 2020 meeting. 