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Joseph F. Panarelli MD, Steven J. Gedde, MD, and Vikram Paranjpe MD, MPH discuss the Primary Tube Versus Trabeculectomy (PTVT) study.



BLOG: The PTVT Trial and Clinical Applications

Joseph Panarelli, MD, and Arsham Sheybani, MD, discuss the Primary Trabeculectomy for Advanced Glaucoma: Pragmatic Multicentre Randomized Controlled Trial, or TAGS trial, and how this can apply to real world situation. This multicenter randomized controlled trial evaluated whether primary trabeculectomy or primary medical treatment leads to improved outcomes in terms of quality of life, clinical effectiveness, and safety. 

Blog: TAGS trial and real life applications

A recurring feature at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting in Boston, Massachusetts, was the call for environmentally friendly practices worldwide, with the goal of decreasing the impact of ophthalmic surgeries on the planet.

A driving force in this movement is EyeSustain

 an organization dedicated to the development of such friendly environmental practices, that exists as a global coalition of eye societies providing education and resources to support sustainable practices in ophthalmology.

Here is a sampling of the ASCRS discussions on the topic.

Greening eye care: reducing ophthalmology’s environmental footprint

The presenters, led by first author Sarishka Desai, BA, described the EyeSustain platform and its 5-pronged mission: educate the global ophthalmic community about more sustainable practices, collaborate with industry to reduce our carbon footprint and surgical waste, support research and innovative solutions that reduce ophthalmology’s environmental impact, support advocacy and education about the public health impact of climate change, and collaborate with industry to reduce our carbon footprint and surgical waste.

Desai, of the University of Connecticut School of Medicine in Farmington, and colleagues presented EyeSustain’s approach to reducing the ophthalmic carbon footprint. She was joined in the study by Nitya Devireddy, BS, MPH, of Penn State College of Medicine in Hershey, Pennsylvania; Sofia Miguez, BA, of Yale School of Medicine in New Haven, Connecticut; and Barbara Erny, MD, of the Department of Ophthalmology at Stanford University in California.

The greenhouse gas data associated with health care are startling. Health care is responsible for 4.4% of all global greenhouse gas emissions, 71% of which arise from the manufacturing, use, and disposal of medical supplies. Ophthalmology has the highest procedural volume of any surgical specialty, with 50 million cataract surgeries expected to be performed globally each year by 2050, Desai reported.

In light of the procedural data, the authors highlighted 6 areas that are currently undergoing research and quality improvement initiatives through the EyeSustain system.

 of cataract surgeons and nurses by David Chang and Cassandra Thiel found that 93% of respondents believe that the trash associated with OR procedures is excessive, and that methods to reduce waste should be identified and implemented.

 encouraged regulatory agencies to allow electronic instructions for use be disseminated in lieu of the traditional paper instructions included with each cataract pack.

Ongoing projects spearheaded by EyeSustain members, including medical students and ophthalmology residents, are taking a look at educating surgeons and surgical staff about sustainability and the impact of OR waste, OR water consumption, and evaluation of flash sterilization associated with cataract surgery.

In recognition of the fact that medications in the OR represent an estimated $560 million in waste annually, a multisociety position paper

 recently formulated 3 key recommendations: topical drugs in multidose containers can be used for multiple patients in surgical facilities if proper guidelines are followed; topical drugs in multidose containers can be used until the manufacturer’s labeled date of expiration if proper guidelines are followed; and, when applicable, patients should be able to take their partially used medication home for postoperative use.

The Aravind Eye Care system’s low-carbon model from Madurai, India, uses alternate energy sources, transport, infrastructure, and equipment maintenance.

 Studying global systems of eye care and waste produced can provide a deeper understanding of the impact of hospitals and providers on climate change, as well as ideas on how western eye care systems can proactively reduce carbon emissions.

The EyeSustain platform includes ophthalmology-specific action steps for greening offices and clinics in collaboration with the 

Partnerships can be established with large manufacturers to reduce packaging, make instruments reusable, and streamline the manufacturing and distribution processes.

In addition to the impact of practice waste on the environment, EyeSustain also recommends studying the effects of climate change on the incidence rates of ophthalmologic conditions, including cataracts, allergic disease, and glaucoma, among others.

Desai and her colleagues recommended that institutions take the following steps:

Conduct a waste audit to quantify the carbon footprint of an institution’s OR emissions. This includes using the EyeSustain-Zasti Carbon Footprint Calculator, using the Sustainability Index for Disposables in Cataract Surgery calculator for cataract packs to evaluate the item-by-item potential for carbon dioxide savings, and surveying clinical staff to identify areas of perceived excess waste.

Identify key stakeholders at an institution and an enthusiastic, multidisciplinary team and completing the OR Sustainability Pledge (

), which has been completed by ambulatory surgery centers/hospital outpatient departments from 9 countries thus far.

Implement best practices; multisociety recommendations for sustainability are easily accessible at eyesustain.org and My Green Doctor for outpatient/clinic resources and local legislation using the American Academy of Ophthalmology Topical Medical Waste Reduction Act legislative template.

Using phacoemulsification waste to guide changes in surgical sustainability

Adjustments to improve the sustainability of ophthalmic surgical practice can have a large impact when scaled to case volume, according to author Margaret Tharp, BSc, who described this study at the ASCRS meeting. She and her coauthors Stella Protopapas, BA, MPH, and Minka Gill, BSc, are from the Indiana University School of Medicine in Bloomington, whereas David J. Palmer, MD, ABO, is from the Northwestern University Feinberg School of Medicine in Chicago, Illinois.

In their study, they sought to draw connections between results from a 24-hour waste audit at an outpatient surgical center and current resources available from EyeSustain to improve the sustainability of ophthalmic surgical practice.

The authors documented the extensive waste generated from 1 day of surgeries in an institution that included 13 phacoemulsification procedures, 5 plastic surgeries, 3 urologic surgeries, and 5 otolaryngologic cases. The waste products were sorted as medications (eg, propofol, eye drop containers), textiles (eg, surgical gowns, drapes), metals (eg, metal wiring, disposable instruments), and plastics (eg, hard, soft, wrappings).

When the amounts of the waste products were tallied, the authors found that “ophthalmology produced the greatest amount of waste in a single day relative to other operating specialties, despite producing the least amount of waste per case. Most ophthalmic waste was from textiles, hard plastics, and medications,” the authors reported.

The specific 13 phacoemulsification procedures resulted in 95.4 lb of waste broken down as follows: 18.5 lb of hard plastic, 5.5 lb of soft plastic, 8.3 lb of wrapping, 13.5 lb of medications, 41.2 lb of textiles, 6.7 lb of miscellaneous waste, and no metals. Compared with other operating specialties, ophthalmology produced the least amount of waste per case but the greatest amount of waste in total due to the relatively high case volume.

It has been reported that “discarded/unused pharmaceuticals from US cataract surgeries demonstrated waste of [approximately] $150 per case while generating carbon dioxide–equivalent emissions that approximated 25,000 to 100,000 flights from San Francisco, California, to Boston annually.

Small changes can have dramatic results. Tharp and colleagues suggested that the following would have positive consequences.

Revising the use of tetracaine bottles intraoperatively; for example, reusing the bottles between cases or sending the bottles home with patients

Optimizing packaging of surgical supplies and electronic instructions

Utilizing intravenous sedation to limit anesthesia gas carbon dioxide–equivalent emissions

Focusing on cutting waste also creates an opportunity to explore the practices of global leaders in sustainable eye care, such as the efforts of the Aravind Eye Hospitals, which provide similar surgical success rates at a fraction of the waste produced by US practices.

 A downside may be that such practices require significant reuse of materials, central sterilization, and stakeholder diligence, which can require complex interventions, according to Tharp. 

EyeSustain’s Surgical Facility Sustainability Pledge can serve as a guide for ophthalmologists to improve the sustainability of their practice in an approachable and lasting manner.

Factors contributing to the carbon footprint of cataract surgery

Omar Taboun, MSc, a medical student at Western University’s Schulich School of Medicine & Dentistry in London, Ontario, Canada, working under the direction of Netan Choudhry, MD, FRCSC, also described the negative impact of cataract surgery on the environment at the ASCRS meeting.

He commented, “We know that climate change can affect human health through various means, such as adverse weather events causing injury and exposure to pollutants [exacerbating] underlying health conditions. As health care providers, it is our responsibility to treat patients for their conditions that may ultimately be influenced by environmental factors. Counterintuitively, the health care sector is itself a greenhouse gas emitter,” Taboun said.

Surgery contributes significant emissions to the environment through the necessary materials and tools used during procedures. In addition, the need to maintain sterility increases waste.

The term footprint indicates the sum of all emissions direct and indirect resulting from this procedure, Taboun explained, the resultant value of which is typically reported in carbon dioxide equivalents

And although cataract surgery requires only a few minutes to complete, the procedural volume has increased exponentially over the past 2 decades,

Taboun and colleagues developed a 2-fold goal: they wanted to increase their understanding of the carbon footprint and waste accumulation to identify the primary contributors and pinpoint areas for improvement to enhance the sustainability of cataract surgery.

They conducted a literature search of PubMed, Google Scholar, and Medline to identify studies related to the carbon footprint and the elements of cataract surgery. The results yielded 6 studies, with 2 being the basis for this discussion,

He highlighted 3 main points extracted from the published data: the lowest footprint published was just under 6 kg of carbon dioxide equivalents; the highest published footprint was just over 180 kg of carbon dioxide; and the major factors contributing to the footprint include procurement of pharmaceuticals and materials, building and energy use, such as heating/cooling, lighting, electricity-powered tools, and travel by patients and staff to the location where the procedure is performed.

Taboun directed attention to centers that already have sustainable practices in place, such as the Aravind Eye Hospital, which reports the lowest footprint. These sustainable practices include the use of multiple operating tables in a single room; reusing gloves, gowns, and various medical equipment;

and using highly efficient autoclave settings.

Importantly, when these changes were implemented in the Aravind Eye Hospital,

 the rates of endophthalmitis remained comparable to other centers: 0.02% vs from 0.04% to 0.07% reported.

Taboun offered 3 ways that surgeons can offset the negative effects of cataract surgery on the environment—by focusing on procurement, energy use, and travel emissions.

Reduce emissions associated with procurement by collaborating with manufacturers to reduce packaging as much as possible and encouraging recycling in every OR.

Reduce building and energy use by incorporating renewable energy, such as solar panels, and more strategic lighting protocols and optimizing energy use within surgical centers.

Establish outreach clinics closer to more populous regions, whereby mostly staff members must travel, and patients less so, which will reduce travel emissions, along with performing bilateral procedures.

“Implementing sustainable practices, although challenging, will allow us to continuously provide this procedure and restore vision for millions of people at less of a cost to the environment,” Taboun said.

1. Chang DF, Thiel CL; Ophthalmic Instrument Cleaning and Sterilization Task Force. Survey of cataract surgeons’ and nurses’ attitudes toward operating room waste

. 2020;46(7):933-940.doi:10.1097/j.jcrs.0000000000000267

2. Schehlein EM, Hovasesian J, Shukla AG, Talley Rostov A, Findl O, Change DF. Reducing ophthalmic surgical waste through electronic instructions for use: a multi-society position paper. 

. 2024;50(3):197-200. doi:10.1097/j.jcrs.0000000000001381

3. Cleaning and Sterilization Task Force. Reducing topical drug waste in ophthalmic surgery: multisociety position paper

. 2022;48(9):1073-1077; doi:10.1097/j.jcrs.0000000000000975

4. Goel H, Wemyss TA, Harris T, et al. Improving productivity, costs and environmental impact in International Eye Health Services: using the ‘Eyeficiency’ cataract surgical services auditing tool to assess the value of cataract surgical services. 

. 2021 ;6(1):e000642. doi:10.1136/bmjophth-2020-000642. 2021

5. US EPA O. Greenhouse gas equivalencies calculator. United States Environmental Protection Agency. Updated January 2024. https://www.epa.gov/energy/greenhouse-gas-equivalencies-calculator

6. Gadani H, Vyas A. Anesthetic gases and global warming: [otentials, prevention and future of anesthesia. 

. 2011;5(1):5-10. doi:10.4103/0259-1162.84171

7. Thiel CL, Schehlein E, Ravilla T, et al. Cataract surgery and environmental sustainability: waste and lifecycle assessment of phacoemulsification at a private healthcare facility. 

. 2017;43(11):1391-1398. doi:10.1016/j.jcrs.2017.08.017

8. Pandey D, Agrawal M, Pandey JS. Carbon footprint: current methods of estimation. 

. 2011 ;178(1-4):135-160. doi:10.1007/s10661-010-1678-y

9. Pandey D, Agrawal M, Pandey JS. (2011). Carbon footprint: current methods of estimation. 

. 2011;178(1-4):135-160. doi:10.1007/s10661-010-1678-y

10 Rachmiel R, Trope GE, Chipman ML, Buys YM. Cataract surgery rates in Ontario, Canada, from 1992 to 2004: more surgeries with fewer ophthalmologists. 

11. Morris DS, Wright T, Somner JEA, Connor A. The carbon footprint of cataract surgery. 

. 2013;27(4):495-501. doi:10.1038/eye.2013.

12. Latta M, Shaw C, Gale J. The carbon footprint of cataract surgery in Wellington. 

13. Ravindran RD, Venkatesh R, Chang DF, Sengupta S, Gyatsho J, Talwar B. Incidence of post-cataract endophthalmitis at Aravind Eye Hospital: outcomes of more than 42,000 consecutive cases using standardized sterilization and prophylaxis protocols. 

. 2009;35(4):629-636. doi:10.1016/j.jcrs.2009.01.002

14, Pershing S, Lum F, Hsu S, et al. Endophthalmitis after cataract surgery in the United States: a report from the Intelligent Research in Sight registry, 2013-2017. 

. 2020;127(2):151-158. doi:10.1016/j.ophtha.2019.08.026

Organization eyes green practices, shifting ophthalmology landscape.

Minimizing the carbon footprint of ophthalmic surgeries

ASRS 2024:

Stephen Russell, MD, discussed his presentation on safety and durability of voretigene neparvovec-rzyl for biallelic RPE65 at the annual ASRS meeting in Stockholm, Sweden.

Editor's note: The below transcript has been lightly edited for clarity.

Hi, I'm Steve Russell from the University of Iowa. I am one of the principal investigators on the phase 3 trial of voretigene neparvovec-rzyl, otherwise known as Luxturna. I'm here at the ASRS presenting the 8 and 9 year follow-up results of the trial, which are quite interesting. Unfortunately, we lost quite a few patients to follow-up during COVID. In the data that we presented, we realigned the data a bit. Let me explain about that. So the trial, as you may recall, involved randomizing the patients 2 to 1 to immediate treatment versus delayed intervention, which was allowed 1 year after the primary endpoint was determined. 

The primary endpoint was met all of the patients who participated in the trial that were in the control group, the delayed intervention group, then we're allowed to get the voretigene neparvovec-rzyl. So to look at how patients are responding over a longer period of time, as we begin to lose patients from the trial because of COVID and other drop out, we realigned to the intervention points of the delayed intervention with the original intervention group, so that we would have the same duration from the intervention to look at how they were doing following intervention. 

As you recall, the original intervention group did quite well improved approximately 2 light levels on the mobility test, the multi-luminance mobility test, FST, visual field ,and so on. The delayed intervention group did similarly, and over the longer term in 8 to 9, and the reason it's 8 to 9 year follow up is because it's 8 year follow-up for the delayed intervention and 9 year follow up for the original intervention because they were in, they had been treated for an additional year at our follow-up time points. 

The bottom line of the study is that for a majority of measurements, especially the mobility tests, the MLMT primary endpoint, there did not appear to be any drop off in terms of the effectiveness of the therapy at 9 and 10 years, there was a little bit more variability in the visual field out results, which suggested that there may be, there's some patients that are having some loss, or that there may be just a generalized loss, but we didn't look at that these were all averages of the outcomes. There were a couple of safety things that should be mentioned. The first is that we did find 3 cases of chorioretinal atrophy in phase 3 trial, which is significant, since we had not identified those previously. There was also 1 case of acute myelogenous leukemia in 1 patient who died at year 7. There was no evidence, however, that that was associated with the use of voretigene neparvovec-rzyl or gene therapy. 

One of the reasons that we're following patients for so long on this particular trial is that this was the first approved gene therapy for any inherited disease, and because of that, the FDA stipulated that we had to have a 15 year follow-up, we have actually collected already the 10 year information, we just didn't have it available for this meeting. And that will be in the forthcoming publication. We hope to have out soon. But there's additional 5 more years of collection for safety reasons, I think that there are, you know, a whole bunch of exciting areas that are sort of in development and competitively vying for the next breakthrough, inherited retinal diseases, there have been a number of non-gene therapy kinds of approaches using things like RNA oligonucleotide therapy, which is, can be very effective in certain conditions, but has some other kinds of side effects. We don't have time to talk about all of those. There is hope that the more generalized gene therapy of CRISPR Cas-9 might be able to be applied to inherited retinal diseases. It was an attempt to do it on a gene CEP290, which unfortunately didn't reach his primary endpoint. There's reason to think that there may be a way of increasing something called the the cut rate, which is the ability of the CRISPR Cas-9 to be able to cut the DNA in the appropriate location using a primer, which is called prime editing. That looks very exciting. So there are some newer technologies out there, it may be a combination of things. 

There are also a lot of interesting technologies now looking at potentially a broader approach to inherited retinal disease where you may be able to treat more generally with a stabilizing agent, I guess for lack of a better term, for cones, and so there may be some alternative therapies that may be really exciting coming up.

Videos

ASRS 2024: Safety and durability of voretigene neparvovec-rzyl for biallelic RPE65

Thomas Aaberg, MD, gives an update on Neurotech Pharmaceuticals Encapsulated Cell Therapy platform for the potential treatment of Macular Telangiectasia Type 2, with a projected PDUFA goal date from the FDA at the annual ASRS meeting in Stockholm, Sweden.

Hello, I am Tom Aaberg. I am a practicing retina specialist in Grand Rapids, Michigan, and I'm the chief medical officer for Neurotech Pharmaceuticals. I'm at ASRS Stockholm 2024.

I'm excited to be here. On the first day of the program, Dr. Paul Bernstein and Dr. Jack Wells presented updates to our clinical program in Mactel 2. Mactel 2 is what is considered to be an orphan disease. It's actually a neurodegeneration of the retina, rather than its name implies, which would be a vascular cause. This is a progressive disease that affects the macula. It begins with paracentral scotomas. Patients notice metamorphopsia, blind spots, difficulty reading. Near tasks are particularly challenging for these patients. Unfortunately, it can be very subtle in its initial presentation, and is often either undiagnosed or misdiagnosed for years, which can lead to some obvious frustrations for the patient. OCT has been critical for these patients. It's been key in diagnosing Mactel. The advancements of OCT-A has even been more valuable for these patients

For those unfamiliar with Neurotech, we have a first-in-class encapsulated cell therapy. This innovative approach harnesses the power of allogenic retinal pigment epithelial cells that we can genetically engineer to produce a variety of therapeutic factors. Our NT-501 device, in particular, is designed to produce ciliary neurotrophic factor for the treatment of Mactel 2. As demonstrated by Dr. Wells and Dr. Bernstein, our NT-501 has been shown to be efficacious in 2 parallel Phase 3 trials and maintains a favorable safety profile. We've submitted our biologic license application to the FDA. They have granted us a PDUFA goal date of December 17, 2024. We at Neurotech are super excited... look forward to hopefully a positive outcome. We're also very excited for the potential benefit this could have for Mactel 2 patients and look forward to any future advances.

ASRS 2024: Neurotech Pharmaceuticals update on the NT-501 device

Eyenovia, Inc., a commercial-stage ophthalmic company, has entered into a collaboration agreement with Senju Pharmaceutical Co., Ltd.

 With the 2 companies joining forces, they intend to work to develop Senju’s corneal epithelial wound healing candidate, SJP-0035, for use alongside Eyenovia’sOptejet dispensing technology, aiming to use both products as a potential treatment for chronic dry eye disease.

“We are very pleased to further leverage our proprietary Optejet platform through this collaboration agreement with Senju, a global leader in eye care that has been part of the Eyenovia family since our inception,” said Michael Rowe, chief executive officer of Eyenovia.

The companies plan to meet with the US Food and Drug Administration (FDA) to present a clinical development proposal, as stated in the terms of the agreement. If successful, the FDA could support a New Drug Application (NDA) filing for the treatment. The treatment could also have financial benefits as well, as the current cost of the treatment for chronic eye disease is over $3 billion in the US and $5 billion globally.

In prior Phase 1 and Phase 2 studies, SJP-0035 as an eye drop has been shown to be well received at multiple doses tested in over 250 subjects. A planned Phase 2b trial would test SJP-0035 administered in the Optejet dispenser.

Mitsuyoshi Isaka, a corporate executive officer of Senju, said, “SJP-0035 has a unique mechanism of action that has the potential to offer dry eye patients additional relief when compared to existing treatment options alone, while also demonstrating a very favorable tolerability profile. When integrated with a novel dosing platform such as the Optejet, we believe we can create a more efficacious and highly differentiated treatment that could quickly become the new standard of care for this very prevalent ophthalmic condition. We look forward to a long and mutually successful partnership.”

A meeting with the FDA is expected later this year, followed by the execution of a definitive agreement relating to the further development of SJP-0035 and the anticipated completion of a Phase 2b study next year. With approval, the companies could expand upon their collaboration agreement to bring the product into 2 Phase 3 studies by 2026.

Eyenovia and Senju Pharmaceutical Co., Ltd. Sign Collaboration Agreement for Potential New Treatment for Chronic Eye Disease. News release. Yahoo! Finance. Accessed July 23, 2024. 

Eyenovia and Senju Pharmaceutical Co., Ltd. Sign Collaboration Agreement for Potential New Treatment for Chronic Dry Eye Disease (yahoo.com)

The collaboration agreement will allow the 2 companies to find a potential new treatment for chronic dry eye disease.

Eyenovia, Inc. and Senju Pharmaceutical Co., Ltd. sign new collaboration agreement

ASRS 2024: Update on the phase 2 DAVIO 2 trial

Jennifer Lim, MD, FARVO, FASRS, gives an update on the phase 2 DAVIO 2 trial comparing EYP-1901 with aflibercept at the annual ASRS meeting in Stockholm, Sweden.

Hello, I'm Jennifer Lim from the University of Illinois at Chicago, where I serve as a Marion Schenk Chair of Ophthalmology, Vice Chair, Director of the retina service, and UIC distinguished professor of ophthalmology. The DAVIO 2 was a phase 2 clinical trial that compared the use of a tyrosine kinase inhibitor, [EYP-1901], to aflibercept given on label after loading, 2 milligrams Q8 weeks. The [EYP-1901] was given after aflibercept was given to achieve control of the neovascular disease in eyes with age-related macular degeneration. It was given either in a 2 milligram dose, or a 3 milligram dose. And this is a bioerodible drug that is injected into the eye. Following the use of [EYP-1901], patients were then followed to see whether they needed supplemental injections.

Of course the patient's given aflibercept were then dosed at Q8 weeks on label. For both of these groups, patients were allowed to receive supplemental injections of aflibercept 2 milligrams as needed. For the [EYP-1901] 2 milligrams and 3 milligram groups, the number of supplemental injections was markedly reduced. In fact, two-thirds of patients in this phase 2 trial did not need supplemental injections. Interestingly, in the comparator arm that is of aflibercept, there were approximately 6-8% of patients that needed supplemental injections despite the fact that they were dose Q8. And so what this does is that it gives added durability to patients with neovascular AMD. And the reason for this is that these tyrosine kinase inhibitors are acting directly on the VEGF receptor signaling. So, even though the VEGF binds at the receptor, the signaling doesn't go through. So you don't get the subsequent downstream effects of VEGF because these are blocked by the tyrosine kinase inhibitor. 

This is really exciting news because this really means that we yet have another possible tool in our armamentarium to decrease the treatment burden and really to increase durability. And as we know, for AMD patients, really drying the retina that is getting rid of the IRF and the SRF, really is what's going to preserve the vision. And this will also help us with patients who are lost to follow-up or have other morbidities which makes it difficult for them to return to the clinic. I think this really durable, 1-time injection that can last at least 6 months is going to be a game changer.

Joseph F. Panarelli, MD

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