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Carl Zeiss Case Studies

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

iCare COMPASS Automated Perimeter

Clinical

1rem

Look for fluctuating vision, test objectively and keep a few effective tools at your disposal to treat OSD.

Paying attention to ocular surface disease preoperatively matters

Stromal regeneration seems possible in patients with keratoconus.

Keratoconus: Intrastromal implantation of fresh human lenticules 

The technology will be available soon for ophthalmologists in select countries across Asia Pacific and Europe.

Novel corneal refractive technology from Johnson & Johnson Vision receives CE Mark approval

The Keralink Trial was the first randomized clinical trial that tested the hypothesis that corneal cross-linking (CXL) might decrease keratoconus progression in children compared with the use of spectacles or contact lenses. 

APAO 2023: Keralink Trial and efficacy safety of corneal cross-linking for children with Keratoconus

Three recipients will each receive up to $10,000 toward their research on a 1-year project that can go toward additional training in specialty equipment or research methodologies.

Winners of 2023 ARVO research fellowships announced

This transcript has been lightly edited for clarity.

My name is Adam Szaronos. I'm the CEO at Trukera Medical. We're so excited to be here this year in Chicago at the American Academy of Ophthalmology for a number of reasons. At Trukera Medical, we've recently rebranded our organization historically founded as TearLab, a one-product company focused on in vitro diagnostics to help advance corneal health and decision making.

After nearly 25 million tests globally, today, we're now launching our second generation system. And with that opportunity, we're now also in a position to start looking across the spectrum of corneal health needs. And with an expanded vision to be the world's leading cornea health company for providers and patients, we felt it was appropriate to make sure we had a company identity that better reflected that growing portfolio in vision.

The second reason we're excited to be here is the launch of that product itself. We've learned a lot over those 25 million tests, in particular the barriers it takes to helping to get good diagnostic testing into the hands of today's busy cataract and refractive practices. We knew we needed a solution that was portable, practical and precise. And over the last two years, we've been working on that solution. It's called the ScoutPro Osmolarity System. It's the first in the US, portable, handheld objective diagnostic test to help physicians identify at-risk osmolarity levels prior to refractive surgery, and also help patients evaluate and manage those lab results to determine therapy after surgery.

Videos

Adam Szaronos, President and CEO of Trukera Medical, discusses the recent rebranding of TearLab as well as the launch of the ScoutPro Osmolarity System.

Video Series

Expert Interviews

Trukera Medical rebranding ushers in new era of expansion into cornea market

At the 2022 American Academy of Ophthalmology meeting, Dr Philip Dockery, MPH, presents, "Effectiveness of corneal crosslinking in young patients."

NOINDEX

NOFOLLOW

Younger patients often require repeat corneal crosslinking, study finds

David Hutton discusses the AAO 2022 talk, "Corneal Oedema, Opacifications, Ectasia, and Bacterial Keratitis: Diagnosis and Treatment Strategies from the Preferred Practice Pattern Guidelines," with presenter Dr Francis S. Mah.

Utilising AAO cornea preferred practice patterns for corneal oedema, opacifications, ectasia and bacterial keratitis

 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

 So thank you for joining me at this year's ESCRS, Professor Dirisamer. I understand tomorrow you're due to present on DMEK. I would love to hear more about that. Could you tell me the key takeaways from the instructional course?

 Yeah, thank you for the kind invitation. Yeah, we are having a course about DMEK and how to avoid mistakes in converting to DMEK because it was like a kind of transformation from PK and DSAEK. And, you know, obviously, mistakes we made, we try to [make it so] the younger people do not have to do the same mistakes. Well, it's about the indication, how to start and what are the key points where I can avoid complications, and to get together the perfect outcomes.

So it's, I think, very important for a beginner to start with DMEK, to pick up easy cases. So not start with challenging cases. But pick easy cases. And from there, follow certain rules. So if you follow these rules, and these suggestions, I think it could do this transformation pretty easily.

 And so do you think that'll be a good uptake on DMEK in and amongst the younger ophthalmologists?

 Yes, I think it's, at least in German-speaking countries, I think the most popular transportation. And so I think the younger colleagues, they started with us; in my case, it was the same thing. So I think you can kind of overtake the other data procedures that don't have to DSAEK anymore. They can start right away with DMEK.

And, yes, so we tried to give them a kind of stepwise approach to solve problems we have to face in the beginning with DMEK. And, yeah, I think this could work out for most people. Of course, you need some surgical skills, you need some surgical training as well. But you also should be aware of the theory behind.

 Yeah, that's I think that for younger people and younger colleagues, I think this might be a good basis.

 Yeah. And what would you say the main challenges in performing this procedure? What goes wrong most often?

 I would say the most the most challenging part is that it's basically a two-step surgical procedure, so you have to prepare your graft, sometimes on your own. Of course, there's prepared tissue available, but in many parts of the world, there is not. So you have to prepare the tissue both by yourself; this is the first challenge. You have a challenge already, and the surgery part hasn't even started.

 Of course, you have to know how to store this tissue, how to stain it. And so it's a combination of many things. I would say complication number one, if you make a sealed [audio unclear] detachment. But on the other, the other side, it's not a big complication. You can solve it pretty easy. But it's better to avoid it. So we do everything that we can to not get a complication, and there's some tips and tricks, how you can do that.

 All right. Well, it sounds like it would be a great course for ophthalmologists to attend tomorrow. I'm sure they're very much looking forward to learning more.

 Yeah, oh well, I can imagine. It sounds really interesting. Thank you very much for sharing that with me here.

Prof. Martin Dirisamer discusses his instructional course on common mistakes when performing DMEK and how to avoid them at ESCRS.

Avoiding errors when converting to DMEK

 So thank you for joining me here Professor Bostanci. I understand you've given quite a few presentations at this year's ESCRS, and it's lovely to meet you here in Milan. I'm the editor of Ophthalmology Times Europe, and I would love to hear more about EDOF lenses and the key takeaway points from your presentation.

 Thank you, I will be more than glad to answer this question. So I am Basak Bostanci, an associate professor of ophthalmology from Istanbul, as you said, and here in Milan, there was a great discussion about EDOF lenses as an option for presbyopia correction.

So, in the past, these trifocals diffractive, optic trifocal lenses, were only given as a solution to people who had the most wonderful ocular surface and ocular anatomy. So people with some dry eye issues and people with compromised corneas were not eligible. With EDOF lenses, we have a slight chance to offer them a premium solution for giving them a functional vision, which is arm-length vision.

So intermediate vision is very important in our daily lives, we are checking our telephones, we are cutting something on the table, we are preparing meals for our children. So functional vision is really depending on how we see far and how we see at arm distance. So these EDOF lenses provide us intermediate vision.

And because most of them are not verging on a refractive principle, we can offer them also to our dry eye patients, to our patients who had received refractive surgeries.

So what I love about these lenses are if the patient doesn't have a fully compromised cornea, or geographic atrophy in the retina, or severe glaucomatous damage, now we can offer them a premium lens option to make their lives easier.

 Yeah, yeah. Oh, that sounds really good. I mean, there's so much information in the field at this conference. And is there anything that you would say you're most excited about going forward to the future?

 Yeah, I like walking through the technology. So these EDOF lens technologies are very different from one another. So I love in those congresses, the best part of those congresses is we can go ahead, meet the inventors of these wonderful intraocular lenses, and we can compare one to another and find a good option for our particular patients. So thank you for asking me this question.

 Oh, no problem. You're welcome. Well, it was really lovely to speak to you and I'm sure our readers and subscribers to OTE will be very interested to hear what you have to say. And thank you very much.

Assistant Prof. of ophthalmology Basak Bostanci discusses her ESCRS presentation, “Extended Range Of Vision In Unusual Cases” and how EDOF lens technology is evolving to include a wider pool of candidates.

EDOF lens tech is evolving to help more patients with intermediate vision

This is a sub-analysis of a larger trial looking at a compound called OC-01 (varenicline solution) as a treatment for symptoms and signs of dry eye.

This larger study involved hundreds of patients that had different symptoms and signs compromising the dry eye umbrella. And the question we wanted to ask, because there are so many different phenotypes within dry eye, is: How would this compound do in patients with autoimmune-associated dry eye?

And we defined autoimmune pretty broadly: anyone who had an associated comorbid autoimmune disease. And the rationale for this is because the hypothesis may be these patients have a more severe dry phenotype and would be less likely to respond to treatment. And so that is the question that we aimed

We identified 31 people out of the larger trials who had a comorbid autoimmune disease, and we look to see how they did. This was a placebo-controlled study, so, how the cases who were treated compared to placebo, and how overall they compare to the larger study findings.

The punch line is that they did just as well as patients without autoimmune-associated dry eye. Which is great; it means that we're still trying to understand how OC-01 will be used in the general dry eye population, but it doesn't seem that patients with autoimmune disease do any worse than patients without autoimmune disease. And so that is the main takeaway, and a really important one for clinicians.

When you're looking at the data, the biggest wow effect was in terms of dry eye signs. A majority of individuals that were treated with OC-01 had a greater than 10-millimetre improvement in Schirmer at four weeks compared to controls. Symptoms, as is the case in most dry studies, were more variable. But either way, there was an improvement in both signs and symptoms. The side effects, most common was a sneeze, and most common were reported as mild, and that's in the whole population.

The takeaway of this study is that there doesn't seem to be a specific dry eye phenotype that does better or worse. And so we'll still have to look and see how this does in the global landscape of dry eye, but patients with autoimmune-associated dry eye did just as well as patients without autoimmune dry eye in responding to this compound.

Takeaway: there doesn't seem to be a specific dry eye phenotype that does better or worse.

OC-01 (varenicline solution) investigated as possible treatment for dry eye symptoms, signs

Gloria B. Chiu, FAAO, FSLS, sat down with 

executive editor David Hutton to discuss her poster, "Impact of Delayed Corneal Crosslinking in Keratoconus Patients," presented at ARVO 2022 in Denver, Colorado, United States.

Hi, David, thank you so much for this opportunity to be here with you today. Well, it's exciting, first of all, that ARVO was able to bring so many people back in-person to discuss research and all the exciting things we've been learning about and not able to communicate with each other over the last two years.

So my poster, as you mentioned, is titled, "Impact of Delayed Corneal Crosslinking in Keratoconus Patients." Now this poster is really only a sampling and giving us a taste of what we've been seeing in clinic, we would like to in the future share more of a case series including more patients, and the changes we saw on their eyes.

In this particular poster, my colleagues and I from the USC Roski Eye Institute in Los Angeles, discussed data from three patients. So essentially, in summary, the impact of delayed corneal crosslinking in patients who are candidates for this treatment can be very devastating.

And this was seen through these three patients. Due to various reasons, insurance being one of them, lost to follow up, and also the pandemic, we had challenges managing these patients ideally.

So because they were diagnosed with keratoconus, [and] they were young, we wanted to get them this treatment, but many of them had challenges getting insurance approval. Now, as we know, [the] FDA approved corneal crosslinking in the United States in April of 2016. So some of these patients that I was following were referred for crosslinking around that time, around 2017. Insurance coverage wasn't as good as it is now, so back then we really had challenges getting them the coverage they needed.

So we shared three cases on this poster. The first was a 26-year-old female. Essentially, she presented with keratoconus more in her left eye than the right. She had no scars in her right eye but some striae in the left eye. She was referred for crosslinking but because it wasn't covered by her insurance at that time, she couldn't get the treatment. She ended up getting fit with scleral contact lenses in 2017, but as we know the contacts didn't do anything to help the progression of the disease. So unfortunately, even though she could see better, she developed scarring. Then we kind of lost her to follow-up didn't see her back until November of 2020 when we noticed significant progression in her keratoconus. Now she had scars in both eyes, and her glasses were no longer functional. And it's been really challenging and just devastating to see the impact on her eyes and her vision, given that she's a young 20 year old.

Another case, we shared another young Caucasian male. Similarly, he had moderate keratoconus presented in 2017. And he had RGP contacts for many years. But over the years between 2017 to 2019, we followed his corneal tomographies and he looked okay, but then in 2020, when he came back we saw a significant progression. And now we saw central corneal scarring and the right eye. So with keratoconus, we look for changes through the slit lamp, such as corneal thinning, corneal striae corneal scarring. So when we saw this scarring, we referred him immediately for crosslinking. He had it done in March of 2021, in his in his right eye, and then May of 2021, in his left eye. But again, due to the pandemic, which, you know, started in about March of 2020, we weren't able to get him treated as early as we would have liked. And so we did see unfortunately steeping in his corneal topographies.

And with our last patient, he's 44. But, you know, although we generally expect keratoconus to progress in the teens and 20s, it certainly can still progress, especially if there are environmental factors such as eye rubbing. So this patient, 44-year-old, he had significant ocular allergies, floppy eye lid syndrome, and lots of eye rubbing. So he was referred for crosslinking as well, he were RGPs (rigid gas permeable lenses). He had crosslinking in one eye in his in his left eye in August of 2018. Thankfully, however, with his right eye, he had no scars. And he was referred out for improvement in his contact lens fitting, so he got Sclera Lenses, and with changes noted in his right eye later on. So he came back for his routine Scleral Lens care. But then we saw scarring in his right eye when previously we hadn't noted it. And when we sent him out for cross linking for his other eye, we again notice challenges with insurance coverage, even though he had it done in his other eye.

So these are just three instances of keratoconic patients who experienced challenges in getting timely corneal crosslinking that has led to permanent changes in their corneal structure, as well as best-corrected vision. And that's what the poster shows, with some of the images, the tomography that we have. Ultimately, we want to avoid advanced signs, such as corneal scarring, which we know will impact vision. And in our table, we just show essentially the delay these patients experienced and in our case, it wasn't just weeks or months. In some cases, it was years, because they were seen, you know, so soon after the FDA approval, and insurance coverage back then in 2017, wasn't as robust as it is today.

So we noticed changes in their prescription getting higher, decreased best-corrected vision steepening in their K measurements (their keratometry measurements), as well as thinning in their corneas. So with these changes — thinning, also, the development of scarring — these are things that cannot be reversed.

Through this poster — through these three cases — we really want to get the point out that we should initiate crosslinking as soon as possible in good candidates, particularly young individuals, and especially those with ocular allergies or who have history of eye rubbing, because these actions can lead to progression of the disease more rapidly. So particularly with the last couple of years in access to care, delays due to the pandemic, a lot of our patients unfortunately struggled with getting timely treatment; but now, hopefully moving forward once we make the proper diagnosis, and also confirm that they either have progressive keratoconus or ectasia following refractive surgery, we can get them the care they need as soon as possible.

The study evaluates three separate cases, each of which experienced irreversible changes in their corneal structure caused by challenges in getting timely treatment due to various reasons, including insurance, lost to follow up, and the COVID-19 pandemic.

Ill-timed corneal crosslinking led to permanent changes in corneal structure in patients with keratoconus

The PEARL [phase] 2 study was looking at the compound OC-02 in treating dry eyes. This is a nasal spray that is used twice a day.

Their primary endpoints were to look at increasing Schirmer's, as well as eye discomfort score. By using this nasal spray twice a day, in four randomized groups — so three different concentrations of OC-02 versus placebo — they found that the Schirmer scores were significantly higher in the drug arms, especially the highest drug concentration. And the eye irritation score was also improved most with the highest concentration of the drug.

This molecule is very similar to the OC-01 molecule, which has been FDA approved and marketed. This particular molecule, because of OC-01 being on the market already, is not going to be licensed in the US for marketing.

The take home message is that the use of the cholinergic agonists as a nasal spray to stimulate the trigeminal nerve is a reasonable mechanism to help treat dry eyes. It's novel; it's different than putting eyedrops in your eyes. It may be beneficial for patients who have trouble putting eyedrops in their eyes. A lot of people are used to using nasal sprays for allergies, for example. And so this modality of treatment, as well as a new mechanism, may have extensive benefits for the patients.

The study's primary endpoints were to look at increasing Schirmer's scores, as well as eye discomfort score.

Investigating efficacy of OC-02 to stimulate the trigeminal nerve for the treatment of dry eyes

Dr Preeya Gupta, ophthalmologist at Triangle Eye Consultants, shares her four pearls for corneal collagen cross-linking.

Dr Gupta recommends that ophthalmologists manage patient expectations, monitor epithelial cells and warn about infectious keratitis. Because every patient is different, it is crucial that patients understand that their healing process may not look like another patient’s. Ophthalmologists may find clinical and interpersonal success when they see patients frequently postoperatively, according to Dr Gupta, because they can monitor how the epithelium is healing and counsel patients at the same time.

Well today I talked about corneal collagen cross-linking, which is a very important procedure in managing our patients with keratoconus. It has really been a sight-saving procedure to help halt the progression of keratoconus, which can be an extremely blinding condition.

The do's and don'ts: So we're talking about the FDA-approved protocol, which is the epithelial-off protocol.

I think my four pearls here are related to first and foremost setting expectations for our patients. Sometimes they think of cross-linking as a refractive procedure, which it can have refractive changes as part of it, but I like my patients to really think of cross-linking as a medical procedure that's really aimed at halting the progression of their disease.

I also think it's really important that patients understand that their vision can change for up to a year after this procedure. We certainly see patients that have reduction in their prescription, flattening of their cornea, and while I hope that for everyone, everyone comes out a little bit different.

Epithelial management is very important with cross-linking. Some of the potential complications of cross-linking include haze formation and infectious keratitis. So I think it's very important for clinicians to see their patients frequently postoperatively. And in those cases where perhaps the epithelium is not healing as quickly as we want, we know that these are abnormal corneas, often very steep corneas, which can make epithelial healing a difficult process for some patients. So we want to see them more often; we want to be aggressive about treating their epithelium.

I have a low threshold to actually remove the soft contact lens and place a cryopreserved amniotic membrane to accelerate the healing. I try to remove preservatives from the ocular surface, and then sometimes even lower the steroid dose initially to aid with epithelial healing.

Last but not least, infectious keratitis is something to consider. This is of course a dreaded complication of really any surgery. And so I have my patients stay on an antibiotic drop until re-epithelialization occurs, and I have a very low threshold to culture and you know, see my patient more frequently so that we can identify any infectious keratitis quickly and treat it.

Dr Preeya Gupta walks through her four pearls for successful corneal collagen cross-linking, including handling patient expectations, managing the epithelial cells and preventing infectious keratitis.