Leila Chew is a medical student in the Glaucoma Division at Stein Eye Institute at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), United States.

Alterations of the outer retinal layers from age-related macular degeneration (AMD) can interfere with the automated segmentation of the individual retinal layer thicknesses with macular optical coherence tomography (OCT), the standard technology used to evaluate the central retinal ganglion cells for glaucoma. This finding was reported by Leila Chew and her colleagues. Ms Chew is a medical student in the Glaucoma Division at Stein Eye Institute at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA), United States.

As Leila Chew explained, the automated segmentation function in the OCT machine facilitates accurate measurement of the inner macular layer thickness. However, AMD can result in deterioration of the outer retinal layers from the presence of drusen and tissue atrophy, which alters the retinal structure and interferes with the accuracy and automatic segmentation of the inner retinal layers.

Ms Chew and her colleagues took a close look at the effect of dry AMD, specifically drusen and outer retinal atrophy, on the retinal architecture and evaluation of the inner retinal layers. The investigators conducted a study that included 263 consecutive eyes of 167 patients with dry AMD during a 1-year period from May 2020 to May 2021.

After satisfying the inclusion criteria, 125 eyes were ultimately included in the analysis. Of the included eyes, 29 had atrophy and 98 had drusen; all 29 images with atrophy and 53 representative images of the 98 with drusen were analysed.

The drusen in the images were segmented automatically on B scans using a publicly available and validated deep learning approach. The inner plexiform layer/inner nuclear layer boundary was automatically segmented using the software in the Spectralis OCT machine (Heidelberg Engineering). The investigators then evaluated each image to determine whether the segmentation was correct and if there was evidence of any displacement of the inner retinal layers.

“We found that the images began demonstrating incorrect segmentation in the presence of large drusen greater than 150 micrometres (μm), with a 20% chance of failed segmentation with drusen 150 μmto 185 μm in height, and all the images with drusen above 185 μm had incorrect segmentation in our study,” Ms Chew said. “When normalising the drusen height by the total retinal thickness, there was a significant chance (36%) of failed segmentation at ratios of 0.45 or higher.”

Ms Chew explained that the images often showed displacement of the inner retinal layers when the drusen were higher than 100 μm or with a normalised drusen ratio of 0.3 or higher. The study images showed that large drusen compressed the inner macula and distorted the tissue architecture. Inaccurate segmentation of the inner retina was observed.

She also reported that in eyes with geographic atrophy, 87% of the images showed incorrect segmentation. In these images, posterior prolapse of the inner retinal layers resulted from the atrophy.

“Outer retinal diseases can result in distortion of the inner retinal layers, leading to inaccurate segmentation and compression,” the investigators concluded. “Physicians should be aware of these effects when interpreting the results of macular OCT images in patients with glaucoma.”

This article was adapted from Ms Chew’s poster presentation at the American Glaucoma Society’s 32nd Annual Meeting in Nashville, Tennessee, US. She has no financial interest in this subject matter.

Articles

Study images showed that large drusen compressed the inner macula and distorted the tissue architecture, and geographic atrophy resulted in posterior prolapse of the inner retinal layers.

Effect of drusen and atrophy on automated segmentation in OCT images 

When I started a practice in oculofacial plastic surgery, I focused on providing individualised, comprehensive patient care for a variety of needs and goals. Organically, the patients who have come to me for lid margin disease, chalazia, blepharitis and meibomian gland dysfunction (MGD) have also become the patients receiving fillers, laser resurfacing and brow lifts.

One obvious trend has been that dry eye disease is a concurrent problem for virtually all my patients, and we need to address it for optimum comfort and surgical results. Light-based therapy has been a part of my treatment plan for facial inflammation such as rosacea since my training.

With Lumenis Be offering OptiLight, the first United States Food and Drug Administration (FDA)-approved light therapy for dry eye management, the company has become a natural partner to extend my use of light-based therapy to treat dry eye disease.

Let us look at how the therapy fits into the dry eye treatment paradigm and facilitates a very natural extension into aesthetics for any ophthalmologist—all while helping to grow practice revenues via an expanded patient base and list of paid procedures.

So many people are placing intense demands on their eyes with ever-increasing screen time, particularly when working from home. Even meetings are on screen, leaving few opportunities to rest and resume natural blinking.

I see this every day with patients complaining of fatigue, fluctuating vision, gritty eyes and the inability to wear contact lenses full time. They are seeking ways to resume their former quality of life, feel comfortable every day and take their eyes for granted like they did in the past.

I recommend OptiLight for patients with dry eye related to MGD, rosacea or most other inflammatory conditions. It is an extremely powerful tool I have for fighting dry eye disease.

Patients are scheduled for four 10- to 15-minute sessions, spaced 2–4 weeks apart, to short-circuit their inflammation and improve signs of dry eye. Treatment is comfortable, and patients can return to work immediately.

The results build throughout the series of treatments. Afterwards, patients have less redness and inflammation, reduced signs of MGD, and less need for artificial tears. Those patients with extensive screen time often tell me that their vision is clearer because as their tear lake becomes healthier, they no longer need to use eye drops all day.

Patients also appreciate that this is an in-clinic procedure rather than an at-home therapy they need to perform as part of their ever-expanding daily routine. They are very open to the cost of the procedure because they are eager to see the benefits in their daily lives.

Any practice can add light-based therapy as a dry eye procedure in a way that fits nicely into its existing sphere. For example, some practices package dry eye treatment with premium IOLs or treat dry eye post cataract. And because dry eye is so common, treatment can be offered in a wide variety of cases.

In addition to OptiLight, I can individualise chronic therapies depending on the medical history and causes of the condition. Punctal plugs, artificial tears, immunomodulators (ciclosporin ophthalmic solution [Cequa, Sun Ophthalmics]; ciclosporin ophthalmic emulsion [Restasis, Allergan]; lifitegrast ophthalmic solution [Xiidra, Novartis Pharmaceuticals Corporation]) and changes in behavioural and environmental elements all help.

I explain to patients that with individualised treatment, I can return them to a threshold where they can take their eyes for granted and stop thinking about them all the time.

In a practice like mine where some patients are having cosmetic procedures, the expectation of out-of-pocket costs is built in. But that is true in virtually all ophthalmology practices.

Almost every ophthalmologist has some aspect of the practice that falls outside the insurance paradigm, whether it is multifocal IOLs, LASIK or optical sales. Patients pay for light-based therapy as well, and in my experience they are very receptive to the treatment and pleased with the results.

As a dry eye treatment, light-based therapy has aesthetic “side effects” for the treatment area (tragus to tragus including the nose, with the eyes protected). Just like when we use the technology to treat rosacea, light therapy for dry eye reduces the red vessels on the surface of the skin, decreasing inflammation and sensitivity. It also improves brown discolorations and returns the skin to a healthier state and appearance.

Patients appreciate the aesthetic improvements associated with light-based treatment, so it is an easy step to expand treatment to the rest of the face. Rosacea is very common among patients with dry eye disease, and these patients are very receptive to more comprehensive therapy that will make their face look and feel better.

OptiLight has a handpiece specifically designed for intimate treatment of the geography around the eye, and the optional rosacea handpiece makes it easier to treat larger areas. The interface and device design also make it easy to use, with safe protocols and energy levels.

For physicians who already have the technology, light-based treatment of facial rosacea is a natural, easily implemented extension of the practice’s offerings. It can remain a lone aesthetic option to augment dry eye care, or doctors can continue to grow their aesthetic services with an eye towards the needs of their patient population.

Dr Chelnis is a specialist in ophthalmic plastic surgery at Manhattan Face and Eye and an assistant clinical professor of ophthalmology at New York Eye and Ear Infirmary of Mount Sinai, New York, US.

Patients appreciate the convenience and aesthetic improvements of light-based dry eye treatment, and it can also be applied elsewhere on the face.

Driving practice growth: The connection between dry eye and aesthetics

The value of artificial intelligence (AI) is increasing as the technology behind it continues to develop. During the COVID-19 pandemic, when in-person evaluations were next to impossible, the need for using AI and teleophthalmology became clear, according to medical student Eric Kuklinski and colleagues at the Department of Ophthalmology and Visual Science at Rutgers New Jersey Medical School in Newark, New Jersey, United States.

The investigators explained that the pandemic led to increased mobilisation of teleophthalmology and AI resources to potentially provide screening for diabetic retinopathy (DR) and continuity of care for patients with DR. AI has the ability to assess numerous images in a short period of time and determine which patients need emergent care.

Mr Kuklinski and colleagues conducted a retrospective study to assess the ability of AI software to detect DR compared with teleophthalmology and in-person examinations conducted by a retina specialist. The analysis included 80 eyes of 40 patients (male, 45%; average age, 55.1 years).

Sixty percent of the patients were Hispanic, and 65% had a history of type 2 diabetes. The investigators evaluated the patient demographics, retinal photos obtained using the Canon CR-2 Plus AF Retinal Imaging Camera and the diagnosis of DR based on the International Clinical Diabetic Retinopathy (ICDR) classification scale, determined when a retina specialist performed a fundus examination at an in-person clinic visit.

AI software (EyeArt, Eyenuk) was used to grade the retinal photos. The eyes were classified as normal or having mild or more-than-mild DR. In addition, a retina specialist graded the retinal images remotely according to the ICDR classification scale, using TeamViewer software (teleophthalmology). The investigators then assessed the agreement between teleophthalmology, AI and in-person diagnosis of DR.

During the in-person evaluation, a total of 33 eyes were diagnosed with no DR, five with mild non-proliferative DR (NPDR), nine with moderate NPDR, three with severe NPDR, seven with proliferative diabetic retinopathy (PDR) and 23 with regressed PDR, the investigators reported. Eleven eyes were ungradable via teleophthalmology, and AI could not grade 26 eyes.

Comparison of agreeability (using Cohen’s κ coefficient) between the in-person diagnosis and teleophthalmology was 0.859±0.058 (

<0.001), between the in-person diagnosis and AI 0.751±0.082 (

<0.001) and between teleophthalmology and AI 0.883±0.063 (

<0.001). The investigators reported that AI showed a substantial rate of agreement with the in-person diagnoses and near-perfect agreement with teleophthalmology for detecting the presence of DR in this patient group.

Results of the analysis also showed that teleophthalmology grading was in near-perfect agreement with the in-person diagnosis, which indicated that teleophthalmology is a reliable tool to use to remotely screen patients who may be ungradable by AI. However, the investigators offered the caveat that improvements are clearly needed because of the high number of images that are ungradable via teleophthalmology and AI. “Further studies should assess ways to reduce the number of ungradable images and create a trend analysis for multiple visits for a given patient,” they stated.

This article is adapted from Mr Kuklinski’s presentation at the Association for Research in Vision and Ophthalmology 2022 annual meeting in Denver, Colorado, United States. He has no financial interest in this subject matter.

AI and teleophthalmology both show very high level of agreement with in-person evaluations, although further studies are needed to reduce the number of ungradable images.

AI and teleophthalmology appear comparable to in-person DR diagnoses

Minimally invasive strabismus surgery in adults is quicker and safer than the traditional method, according to Dr Yi Ning Strube, an associate professor and director of paediatric ophthalmology and adult strabismus at Queen’s University in Kingston, Ontario, Canada.

During her presentation at the 32nd Annual Jack Crawford Day, an annual paediatric ophthalmology update held virtually in April 2022 by the University of Toronto and The Hospital for Sick Children in Toronto, Canada, Dr Strube described the advantages of the minimally invasive approach.

“Minimally invasive strabismus surgery is less risky to the patient, and less painful, with faster recovery compared to our traditional strabismus procedures,” she explained. “It is easier and faster for the surgeon and therefore less stressful.”

One of the minimally invasive strabismus surgical techniques is the central tenotomy, which can be performed with the patient fully awake as an in-clinic procedure. “This procedure can correct small vertical tropias of 1 to 2 [prism dioptre],” Dr Strube explained. “It is a simple and quick procedure that you can do under topical anaesthesia.”

Dr Strube discussed a case in which a central tenotomy was used on a surgeon who had a retinal detachment that was repaired but had residual vertical diplopia and did not want to wear prism glasses. The procedure provides a surgical alternative to prism spectacles; it corrects very small deviations previously not amenable to surgical correction, as standard rectus muscle recessions correct much larger deviations.

 published in 2009 of 15 consecutive cases by Dr Kenneth Wright, a paediatric ophthalmologist and founder of Wright Center for Pediatric Ophthalmology and Adult Stabismus in Los Angeles, California, United States, looked at the success of the central tenotomy procedure he developed to correct diplopia associated with small-angle strabismus.

Patients in the series were aged 35 –86 years, and 11 of 15 were 60 years and older. All 15 patients had binocular diplopia, and five of 15 were using prism glasses prior to surgery. Dr Wright reported successful treatment of hypertropia with the central tenotomy, but not for esotropia; the procedure is therefore not recommended for patients with esotropia as they often have a much larger underlying esophoria.

Dr Strube outlined a few important steps to keep in mind when performing the central tenotomy. Firstly, topical anaesthetic is applied to the eye, followed by a drop of phenylephrine 2.5% to blanch conjunctiva; this allows for improved visualisation of the anterior ciliary vessels, which should be avoided. Additionally, a drop of antibiotic should be applied.

A 0.50- or 0.75-toothed forceps is used to grasp the central tendon of the rectus muscle through the intact conjunctiva. “You want to move the eye and be sure you haven’t just grasped the superficial conjunctiva,” Dr Strube said.

“Make sure you are using blunt Westcott scissors and be very careful not to go too deep. You are going to hear a click when you cut through the tendon.” The central tendon is cut between the forceps and sclera through the intact conjunctiva, with the central third of the tendon more relaxed, and the two muscle poles left intact, maintaining the normally broad insertion.

“The nice thing is this is repeatable, either at the time of surgery, or if the diplopia should recur,” Dr Strube said. “The patient will tell you if they have improved or not at the time of the procedure if you are performing awake in the office. A procedure like this opens up treatment options for patients without using valuable OR time.”

Another minimally invasive strabismus procedure is the central plication, a rectus muscle tightening procedure. Technically, the procedure involves a modified swan incision over the muscle, Dr Strube noted, citing another study by Dr Wright and Dr Rebecca S. Leenheer, a pediatric ophthalmologist with Family Eye Care and Children’s Eye Center of New Mexico in Albuquerque, New Mexico.

Results of the retrospective study, which categorised patients by hyperdeviations, esodeviations and exodeviations, showed that all patients experienced a decrease in strabismus following the plication procedure. In addition, diplopia was noted in 50% of the adults preoperatively and none postoperatively.

“It corrects more than the tenotomy, about 6 to 8 prism dioptres per muscle,” Dr Strube explained. “Again, this is a procedure you can do under topical anaesthesia. It is a vessel-sparing procedure, and it can be reversed if needed by cutting the sutures in the first day or two. It is really great for small angle deviations. It is hard to do a recession or resection to correct such a small amount (of deviation).”

“On average, you get about 5 to 6 prism [dioptres] per muscle,” Dr Strube noted. “You can correct about 8 prism dioptres if you are performing against a previously recessed antagonist muscle.”

Dr Strube noted that it is important to remember that pulling on the muscle is very painful for the patient and that with minimally invasive strabismus surgery, topical anaesthetic will not completely address that problem. Careful tissue handling and proper technique can avoid pain, for example, by using a traction suture to manipulate the eye rather than pulling on the muscle.

“The central plication is an invaluable technique that is great for patients [post-LASIK and post-cataract surgery] with small-angle strabismus who are keen to be out of glasses, and [it is] an additional technique for complex strabismus patients,” Dr Strube concluded. “Both the central plication and central tenotomy procedures eliminate the need for adjustable strabismus surgery, as these simple techniques can be performed as needed as a touch-up surgery to correct residual small angle deviations.”

Dr Strube has no relevant disclosures related to this content.

1. Wright KW. Mini-tenotomy procedure to correct diplopia associated with small-angle strabismus.

2. Leenheer RS, Wright KW. Mini-plication to treat small-angle strabismus: a minimally invasive procedure. 

Central tenotomy and central plication are just two options that can correct very small deviations previously not amenable to surgical treatment.

Pearls for minimally invasive strabismus surgery

 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.

Disrupting the glaucoma treatment paradigm with novel femtosecond laser from ViaLase

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.

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

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

World Sight Day is upon us and RestoringVision has issued a lofty but doable goal: help solve the global vision crisis.

The organization, established by Mark Sachs in 2003, is engaging its partners around the world to provide vision screening and glasses for people living in impoverished areas where they have less than $2 a day on which to survive.

New donors can help alleviate this scenario in recognition of World Sight Day, which this year is being coordinated by the International Agency for the Prevention of Blindness (IAPB).

The goal, according to IAPB, is “to shine a light on blindness and vision impairment as a major, but solvable, public health issue. Celebrated under the #LoveYourEyes campaign, World Sight Day calls on everyone to prioritize eye health while highlighting the issues facing over a billion people worldwide who cannot access or afford the care they need to see clearly.”

A report from the World Health Organization’s (WHO) World Report on Vision in 2019, outlined in detail the global need for universal eye care, and the global implications of forgoing vision health in communities around the world, according to Dr Pelin Munis, PhD, Executive Director of RestoringVision.

She explained that in 2021, the United Nations built on the momentum created by the WHO report by adopting a resolution, Vision for Everyone, that is encouraging countries to put eye health on the front burner to help the over 1 billion people who have preventable vision impairments. For the first time, the importance of eye health was recognized as a critical component in achieving the United Nations (UN) Sustainable Development Goals.

RestoringVision is also outlining in detail how prioritizing vision health advances eight of the United Nations Sustainable Development Goals that can be accessed by clicking on 

with its blog series on each SDG related to eye health.

Dr Munis point out that in 2022, RestoringVision will transform the lives of 3.5 million people by providing vision services and glasses.

“We are increasing our programmatic footprint in Africa and Asia, and increasing outreach to refugees, specifically those displaced by the war on Ukraine. Donor support is more important than ever to accelerate our impact,” she emphasized.

Dr Edgar Medina, MPH, Executive Director of Management Sciences for Health Peru and one of RestoringVision’s Global Access Program partners, emphasized the importance of partnerships with governments to advance interventions for eye health.

He said, “Low-cost public health interventions and awareness campaigns should be prioritized within Ministries of Health to serve the most vulnerable and low-income populations, addressing presbyopia with the delivery of reading glasses, and addressing the prevention of damage from solar radiation with the delivery of sunglasses with ultraviolet protection.”

Dr Munis further challenged new philanthropic partners to join with RestoringVision on October 13, “by becoming vision champions by donating to RestoringVision’s global programming, by engaging as a corporate partner, and by sharing loud and proud on social media that you support giving the gift of sight to those who lack access and affordability to vision services and eyeglasses. Let’s work towards a world where everyone can see clearly.”

The goal of World Sight Day, according to IAPB, is “to shine a light on blindness and vision impairment as a major, but solvable, public health issue." 

Donations aid in global vision crisis on World Sight Day

14 October 2022 marks the 22nd World Sight Day (WSD), an annual day of awareness, held on the second Thursday of October, to focus global attention on blindness and vision impairment.

"This is a day where we focus the world's attention on the importance of eye care," Dr Constance Okeke, MSCE, of the Virginia Eye Consultants said.

Coordinated by the International Agency for the Prevention of Blindness (IAPB), the international day of awareness is a reminder to "love your eyes."

As part of its efforts, the IAPB and its members are working together to increase public awareness on vision issues and blindness, calling for a focus on vision issues and eye health.

As part of the WSD campaign, IAPB urges eye care professionals, including ophthalmologists and optometrists, to get involved.

"I think it's a great way to advocate and communicate for our patients and for what we do as optometrists; we make a big difference in our communities, and to patients' lives, and I think all optometrists should be celebrating World Sight Day," said Dr Maria Sampalis, owner of Sampalis Eye Care in Cranston/Providence, Rhode Island.

Today, IAPB is promoting a global challenge to unite the world, bringing people across the globe together to have their eyes tested. This year, IAPB is leading the call for people to prioritize their eye health and asking the world’s leaders to ensure eye care is accessible, available, and affordable to everyone everywhere.

"World Sight Day means a little bit different for me, not being from here originally," Dr Adam Ramsey, co-founder of Black EyeCare Perspective, said. "Understanding that the gift that we have—in this wonderful country that we're living in right now—where there is access to care so readily available."

What World Sight Day means to ophthalmologists and optometrists

Sheryl brings a wealth of editorial experience to MJH Life Sciences’ Eye Care Network, having engaged with the readers and the greater ophthalmic community of 

for more than 20 years. As Group Editorial Director, Sheryl’s purview extends across the print and digital network of 

Ophthalmology Times, Ophthalmology Times Europe, Modern Retina 

 Prior to ophthalmology, Sheryl previously covered the fields of audiology and confectionery science/technology/manufacturing.

Sheryl is also passionate about the mission, vision and values of Ophthalmic World Leaders (OWL) and recently completed her term on its Board of Directors. She continues to volunteer as Editor-in-Chief of the organization’s 

Magazine. In 2013, she was honored with the group’s inaugural Rising Star Award.

In addition, she has served as a judge for 

 Health Care Heroes Awards program as well as the Jesse H. Neal National Business Journalism Awards.

 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

Patients are increasingly expressing their desire for spectacle independence after cataract surgery, especially those who have previously received corneal refractive laser procedures for vision correction. Even with adequate preparation using tools such as the Barrett True-K formula, Haigis-L calculator, Shammas-PL formula or the Masket Method to calculate post-refractive surgery IOL power, residual refractive errors continue to be common.

A history of LASIK and other corneal refractive surgery (CRS) procedures means that the patient will often present with an altered corneal curvature that may include complications such as dry eye and other ocular surface issues, making diffractive multifocal IOLs designed for spectacle independence an unsatisfactory option in most cases. Also, most trifocal IOL options are diffractive, which will result in a loss of contrast sensitivity that will likely fail to meet the patient’s expectation.

Attempting a trifocal IOL implantation in such patients, with their corneal and tear film changes, may increase dysphotopic problems and worsen existing distance visual acuity. In addition, this patient group is more likely to have postoperative refractive errors, and the satisfaction with their visual results is likely to be seriously reduced, if emmetropia is not achieved.

In my efforts to find a solution for these patients, I have discovered that non-diffractive extended depth-of-focus (EDOF) lenses, including the RayOne EMV (Rayner), may offer an alternative in challenging post-CRS cases, especially for patients who desire greater spectacle independence without impacting a high degree of baseline distance vision.

In my experience, the RayOne EMV is a good option in such cases because of its higher tolerance to residual refractive errors and ocular surface disorders. With this lens, it is possible to slightly increase the patient’s central positive spherical aberration in a controlled way that neutralises at the periphery of the optic. This reduces the possibility of outcomes such as poor night vision resulting from dysphotopsia and, additionally, makes the lens tolerant to small degrees of decentration.

For these and other reasons, I now consider this IOL the best option in my patients with a history of corneal refractive surgery. In fact, I find myself using non-diffractive EDOF lenses in most of my standard cases that require a monofocal option

When reviewing IOL options with these patients, I first explain the nature of their ocular challenges, and then communicate as to why a trifocal IOL is not a satisfactory option.

I am especially careful to address their desire for spectacle independence. I explain that their outcomes with a trifocal IOL may involve the need for spectacles due to refractive surprises and the increased risk of dry eye which may make them vulnerable to dysphotopic problems which are common with diffractive lenses.

I aim for a goal of mini or modest monovision with RayOne EMV with -0.75 D to -1.0 D offset, and my patients achieve excellent functional vision, remaining independent from spectacles for most of their daily activities, depending on their habits such as reading on screens or small print books.

I will now describe two patients in a case series of those who have received the RayOne EMV, reviewing baseline ocular health and corneal refractive procedure history, patient expectations with IOL implantation, important considerations and initial outcomes.

A 55-year-old male dentist previously received bilateral Supracor treatment to address presbyopia. He stated that he travels 60 km on a motorcycle between his workplace and home every day.

The patient’s preoperative vision level was 0.3–0.4 D (30–40%), and he had nuclear cataracts in both eyes. The goal for this patient was to avoid creating night-time visual disturbances, while enabling clear near/intermediate vision needed for his daily work.

His postoperative vision increased to 1.0 D in the dominant eye (OS) and to 0.8 D in the non-dominant eye (OD), which was planned with a target refraction of -0.75 D (see 

). Our patient stated that he did not need glasses in his day-to-day life, and he did not request glasses for near vision.

A 60-year-old female who had LASIK surgery for astigmatism in both eyes presented with posterior subcapsular cataracts. Our patient, who has type 2 diabetes, stated that she had been receiving cyclosporine treatment for dry eyes for 6 years.

Considering the dry eye, corneal refractive laser history, and her metabolic state, which is likely to result in diabetic retinopathy in the future, IOL implantation with mini-monovision was planned.

The visual acuity of the right eye, which had a preoperative vision of 0.2 D, increased to 0.8 D after the operation, and the left eye, with a planned target refraction of -0.75 D and a preoperative vision of 0.3 D, increased to 0.6. Bilateral visual acuity was 0.9 D. Reading glasses with +1.50/+1.00 D power were prescribed for reading small print.

Dr Bostanci is an associate professor at Medicana International, Istanbul, Turkey. She is a speaker for Rayner as well as several other companies: Bausch+Lomb, Alcon contact lens, Abbvie, Johnson and Johnson, Espansione and VSY.

Non-diffractive lenses offer alternative in challenging post-corneal refractive surgery cases.

Considerations when using IOLs in patients with complex corneas

Baruch D. Kupperman, MD, PhD, reported the findings of a recent survey that most retina specialists in the US and Europe are familiar with the use of anti-vascular epithelial growth factor (VEGF) biosimilars but needed more information to become comfortable with their use to treat retinal diseases.

The survey was distributed via social media by The International Biosimilar Retina Study Group (Inter-BIOS group) of retina specialists with the goal of assessing the awareness by US and European retina specialists of biosimilar intravitreal VEGF therapies.

The 16-question online survey was sent by email, WhatsApp, and LinkedIn from December 1, 2021, to January 31, 2022.

Kupperman explained that the survey addressed topics that would facilitate a better understanding of the awareness of retina specialists regarding this relative new form of treatment in ophthalmology.

A total of 112 physicians (70% women; mean age, 44.7 years) responded to the survey, for a response rate of 56%. The specialists served in a range of professional capacities: 64.2% faculty, 18.75% private practitioners, and 16.9% retinal trainees. Fifty-five responders were in the US and 57 in Europe, he reported.

The primary purpose of the survey, i.e., to assess physician familiarity with anti-VEGF biosimilars, showed that about 55% of responders reported have a basic understanding of the therapy, while about 35% believed that they understood the technology completely. At the low end, the rest of the responders reported having heard or never having heard the term biosimilar.

A question about incorporating biosimilars into clinical practice showed that about equal percentages would incorporate the treatments or would consider incorporation but needed more information before committing to that decision, while about 10% said no, and the rest would make the decision based on insurance reimbursements.

The lower cost of biosimilar ranibizumab (reference drug, ranibizumab, Lucentis, Genentech) would prompt about 30% to shift from off-label use of bevacizumab (Avastin, Genentech) to FDA-approved biosimilar ranibizumab, and 10% would not be moved by lower cost. About 45% needed more scientific information and real-world experience with biosimilars.

The safety of the technology was a major concern for 20%, a slight concern for 50%, and only about 17% were not at all concerned. Efficacy was a slight concern expressed by almost 60%.

When analyzed by location, the US retina specialists had more concerns about efficacy and safety than their European counterparts, 70% and 60%, respectively, versus about 42% and 39%, respectively. The US physicians were more comfortable using off-label bevacizumab.

The overarching message was that US and European retina specialists needed more information about safety, efficacy, and immunogenicity before switching to biosimilars.

The survey addressed topics that would facilitate a better understanding of the awareness of retina specialists regarding this relative new form of treatment in ophthalmology.

Filling in the knowledge gaps: Biosimilars awareness for retinal disease in the US and Europe

Re-Vana Therapeutics Ltd. announced the closure of its Series A round with $11.9 million in funding, an oversubscription of $4 million. 

The financing was led by Visionary Ventures. Additional investors include ExSight Ventures, InFocus Capital Partners and current UK investors Quibis Ltd, Co-Fund NI and TechStart Ventures.

The proceeds will advance the development of Re-Vana's novel and proprietary photo-crosslinked EyeLief, EyeLief-SD and OcuLie biodegradable drug delivery technologies and will enable expansion of the company's operations and development teams.

With the successful completion of key nonclinical ocular safety, tolerability and efficacy studies, Re-Vana has demonstrated that its platform can achieve 6 months or greater sustained delivery of an anti-VEGF biologic at therapeutically relevant levels with high drug loading, controlled burst release, and a favourable degradation profile.

According to the company, its platform has the potential to enable sustained drug delivery via non-surgical administration in office-based settings to treat ocular disease, overcoming several long-standing limitations and challenges in the field.

In conjunction with this financing, Re-Vana's board of directors has been further strengthened by the appointments of Robert Avery, MD, of Visionary Ventures and InFocus Capital Partners, as board member, and Michael O'Rourke, President and CEO of Re-Vana Therapeutics, as Board Chairman.

"Financing from new and existing investors during this challenging time is a testament to the potential of Re-Vana's technologies for sustained delivery of biologic therapeutics," O'Rourke said in a prepared statement. "We are especially fortunate to have received follow-on financing from multiple, highly respected, US ophthalmic-focused venture capital firms and UK investors. Their proven knowledge and expertise in ophthalmology are invaluable additions to Re-Vana as we accelerate the development of our pipeline and expand our strategic partnerships."

"Re-Vana's proprietary technology platforms offer significant potential to deliver both novel and approved biologics for at least 6 months in the clinic, reducing the need for frequent intravitreal injections and extending therapeutic efficacy in the treatment of major eye diseases," Avery pointed out.

Re-Vana is a technology spin-out from Queen's University, located in Belfast, Northern Ireland. The company is currently developing sustained release ophthalmic therapeutics aimed at reducing the frequency of intravitreal injections required to treat a wide range of retinal diseases, including wet age-related macular degeneration. 

In addition, Re-Vana's proprietary photo-crosslinked, sustained-release technology may enable the development of a broad range of novel, sustained-release products applicable to a variety of therapeutic areas.

The funding will give a boost to the development of the company's novel photo-crosslinked EyeLief, EyeLief-SD, and OcuLie biodegradable drug-delivery technologies.

Re-Vana Therapeutics raises $11.9 million to advance ophthalmic technology platforms

For nearly 20 years, neovascular age-related macular degeneration (AMD) has been getting all the attention owing to the introduction of intravitreally administered anti-vascular endothelial growth factor (anti-VEGF) drugs. These agents have successfully stopped disease progression and saved vision in many affected patients.

However, focus has been shifting to the overwhelmingly large population of patients who have the dry, or non-exudative, form of AMD, the insidious type that does not involve the growth of abnormal blood vessels but erodes vision over time. This point was made by Dr Rishi P. Singh, president of Cleveland Clinic Martin North and South hospitals in Stuart, Florida, United States, and professor of ophthalmology at Cleveland Clinic Lerner College of Medicine in Ohio, US.

The end stage of dry AMD is known as geographic atrophy (GA). At this stage of the disease, the activities of daily living—reading, driving, facial recognition and so on—are severely affected, leading to overall serious deterioration of the patient’s condition and quality of life.

 have provided evidence that intravitreal injection of certain inhibitors can cause regression or slowing of vision loss over time in people with GA. “This is how clinicians are currently attempting to treat GA,” said Dr Singh. Findings from these studies have shown advancements in the ability to prevent progression of GA by 15–25%. In the case of GA outside the fovea, that ability increased to 35% — “a good step in the right direction,” he stated.

Dr Singh pointed out that previously, physicians had not looked at GA as closely as they could have, mainly because treatments are only now on the horizon. Optical coherence tomography (OCT) is the main imaging modality, and the emphasis in these images is on identifying exudative AMD and its characteristic fluid or haemorrhages during clinical evaluations. “GA requires reappraisal of these diagnostic techniques to ascertain that the patients with the most need are identified for treatment through the clinical trials,” Dr Singh said.

Dr Singh explained that in routine clinical practice, a few factors come into play, and he acknowledged the need to do better when evaluating and treating patients with neovascular AMD. For example, the number of treatments prescribed is substantially lower in clinical practice than in clinical trials. Additionally, fluorescein angiography is not carried out routinely in clinical practice as it is in clinical trials, although this test may not always be necessary in the clinical setting.

In studies of GA, numerous tests are performed, such as microperimetry and low-luminance vision testing, that are also not routinely performed in clinics; Dr Singh noted that the added benefits in the clinical setting are questionable. In clinical trials, these tests quantify the benefit of the drugs under evaluation for treating GA.

“If I want a very precise measurement of the clinical effect of a drug, tools such as low-luminance vision and microperimetry are invaluable to determine the treatment effect over time,” Dr Singh explained. Although these specific tests are not used often by ophthalmologists, fundus autofluorescence and OCT are used to determine the size and spread of the GA as patients are followed.

Regarding treatments, the effects of the drugs being evaluated are individualised to each patient. “Each patient dictates the clinical suspicions based on how much the disease has progressed and [whether] further intervention is needed,” Dr Singh said.

He noted that he is very pragmatic in these cases when ordering testing. “I use an evidence-based treatment approach, in that if I order a particular test or additional imaging, it is going to help me make useful decisions about a particular patient’s treatment plan,” he explained. This more thoughtful approach will ease the burden in the clinic.

There are several ongoing clinical trials for GA candidates, all of which attack the complement cascade, C3 and C5, both of which are in the alternative complement cascade. Pegcetacoplan (Empaveli, Apellis Pharmaceuticals), a targeted C3 therapy, was recently fast-tracked by the US Food and Drug Administration (FDA) based on the results of three studies: the OAKS, DERBY and FILLY trials.

The drug successfully slowed the progression of GA. “Pegcetacoplan showed significant benefit in its Phase 3 trial and it has a relatively good safety profile. [However], some patients converted to neovascular AMD as a result of treatment with pegcetacoplan, which we need to learn more about,” Dr Singh observed.

Avacincaptad pegol (Zimura, Iveric Bio), a C5 inhibitor, is now being evaluated in a Phase 3 study. The results of the GATHER1 study were similar to those of the OAKS and DERBYstudies. GATHER2,4 which compared monthly avacincaptad treatment with sham treatment, will report results during autumn 2022. “These findings will determine how we will use the drug in clinical practice,” Dr Singh stated.

Dr Singh believes the future of these therapies is very bright, especially concerning the approximately 50% of patients who require the assistance of carers to travel to appointments and other activities. Considering this patient burden, a reduction in disease progression would be a major step forward for patients and carers.

Data from the current studies clearly indicate that there is a great deal of hope for beneficial future therapies for this patient population. Dr Singh recommended that patients under the care of a retina specialist or ophthalmologist should determine whether they are candidates for treatment with these drugs when they become clinically available.

Patients should recognise the importance of family history and lifestyle in the development of GA, both of which are strong predictors of disease development. Smoking, a diet high in saturated fat and not eating fish or green leafy vegetables are key elements in GA development. A change in habits is a good step towards possibly preventing the disease.

Dr Singh is hoping that future versions of drugs for GA could involve sustained drug delivery, eliminating the need for monthly or every-other-month treatments, and combination therapies.

Dr Singh serves as a consultant to Allergan, Bausch + Lomb, Genentech, Regeneron Pharmaceuticals, Novartis, AsclepiX Therapeutics, Gyroscope Therapeutics and Apellis Pharmaceuticals.

1. Liao DS, Grossi FV, El Mehdi D, et al. Complement C3 inhibitor pegcetacoplan for geographic atrophy secondary to age-related macular degeneration: a randomized phase 2 trial. 

2. Apellis announces top-line results from phase 3 DERBY and OAKS studies in geographic atrophy (GA) and plans to submit NDA to FDA in the first half of 2022. Press release. Apellis Pharmaceuticals, Inc. 9 Sep 2021. Accessed 4 Oct 2022. 

investors.apellis.com/news-releases/news-release-details/apellis-announces-top-line-results-phase-3-derby-and-oaks

3. Jaffe GJ, Westby K, Csaky KG, et al. C5 inhibitor avacincaptad pegol for geographic atrophy due to age-related macular degeneration: a randomized pivotal phase 2/3 trial. 

4. Iveric Bio completes patient enrollment of GATHER2 pivotal clinical trial of Zimura ahead of schedule. Press release. Iveric bio, Inc. 26 Jul 2021. Accessed 4 Oct 2022. 

investors.ivericbio.com/news-releases/news-release-details/iveric-bio-completes-patient-enrollment-gather2-pivotal-clinical

Giving patients access to new treatments and information on changing their lifestyle habits could result in major steps towards minimising or even preventing geographic atrophy.