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Ophthalmic data are well suited to the demands of regulatory-grade use cases.

Ophthalmology can set pace for regulatory-grade real-world data

Knowledge of tools used in data interpretation helps clinicians trust accuracy of findings.

Natural language processing pairs with big data curation 

Evidence-based medicine can lead to personalized care, better results for patients

Big data drives opportunity for real-world evidence

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

Melt Pharmaceuticals Inc announced positive topline results from its pivotal Phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT-300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery.

According to the company, based on a Special Protocol Assessment agreement with the FDA earlier this year, the study design and these positive results support the necessary objectives required for a regulatory submission.

MELT-300 combines a fixed dose of midazolam (3 mg) and ketamine (50 mg) in one tablet, which is administered sublingually using Catalent’s proprietary Zydis delivery technology. This technology allows the tablet to dissolve in as little as 3 seconds, enabling absorption of the active ingredients across the sublingual mucosa.

The MELT-300 Phase 3 clinical trial was a randomized, double-blind, three-arm study designed to evaluate the efficacy of MELT-300 for procedural sedation in cataract surgery. Participants were assigned in a 4:1:1 ratio to receive either MELT-300, sublingual midazolam, or a sublingual placebo. Conducted at 13 clinical sites across the United States, the trial enrolled more than 530 patients.

Larry Dillaha, MD, CEO of Melt Pharmaceuticals, said the company was enthused by the topline data from its pivotal Phase 3 study.

“These overwhelmingly positive results support our belief that MELT-300, if approved by the FDA, would be a safe and effective non-IV, non-opioid alternative to current IV-based cataract surgery sedation protocols, which generally involve the administration of opioids,” he said. “With the number of cataract surgeries performed each year in the U.S. expected to exceed 5 million in the coming years, we believe offering patients and physicians the ability to achieve an adequate sedation level without the need to start an IV or administer opioids is a very attractive proposition.”

MELT-300 co-inventor, Melt Pharmaceuticals board member, and board-certified ophthalmologist John Berdahl, MD, said the candidate could offer a sedation alternative.

“A proprietary compounded combination of midazolam and ketamine, which was the inspiration for the development of the MELT-300 product candidate, has been used by hundreds of ophthalmologists, including myself, in hundreds of thousands of cataract surgeries,” he said. “I am thrilled at the prospect of the FDA approving MELT-300, which I believe would greatly enhance the confidence of healthcare professionals in considering the adoption of this groundbreaking sedation method.”

George Magrath, MD, a board-certified ophthalmologist and MELT-300 Phase 3 study principal investigator, pointed out that Phase 3 data show the superiority of the combination of midazolam and ketamine compared with midazolam alone.

“If approved, I believe MELT-300 will be a safe and effective alternative to current sedation methods used for cataract surgery,” he said. “As an ophthalmologist, I am excited about the prospect of using MELT-300 to enhance the overall experience for my cataract surgery patients.”

Moreover, Dillaha noted that, in addition to supporting a regulatory submission, these MELT-300 Phase 3 data should further strengthen the company’s patent portfolio, both domestically and internationally.

“Further, with these data now confirming and complementing our robust Phase 2 efficacy and safety results, we believe we are well-positioned to elevate the procedural sedation standard of care for cataract surgery and, through lifecycle management, eventually expand the potential use of MELT-300 to over 100 million annual procedures in various medical specialties, including dermatology, plastic surgery, dentistry, gastroenterology, and emergency care,” he said.

Dillaha also extended his thanks to the Phase 3 MELT-300 study participants, whose involvement he said had been invaluable.

“This includes the ophthalmologists, optometrists, anesthesiologists, certified registered nurse anesthetists, staff, and patients at the 13 U.S. clinical sites,” he concluded.

1. Melt Pharmaceuticals Inc. Melt Pharmaceuticals Reports Positive Phase 3 Topline Efficacy Results for MELT-300, Its Lead Product Candidate for Opioid-Free, Sublingual Procedural Sedation in Patients Undergoing Cataract Surgery. Published November 20, 2024. Accessed November 20, 2024. https://www.businesswire.com/news/home/20241120082898/en/Melt-Pharmaceuticals-Reports-Positive-Phase-3-Topline-Efficacy-Results-for-MELT-300-Its-Lead-Product-Candidate-for-Opioid-Free-Sublingual-Procedural-Sedation-in-Patients-Undergoing-Cataract-Surgery

Melt Pharmaceuticals Inc. announced positive results from a Phase 3 study of MELT-300, a non-IV, non-opioid tablet for sedation in cataract surgery. The study, aligned with FDA's Special Protocol Assessment, supports regulatory submission. MELT-300 combines midazolam and ketamine, administered sublingually using Catalent’s Zydris technology. The trial involved over 530 patients across 13 U.S. sites, showing MELT-300's efficacy over midazolam alone. The results bolster Melt's patent portfolio and suggest potential expansion to other medical procedures, enhancing sedation standards without opioids.

Melt Pharmaceuticals announced positive results from its Phase 3 study of MELT-300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. The results support a regulatory submission, with potential to revolutionize sedation practices in various medical specialties.

Melt Pharmaceuticals reports positive Phase 3 topline efficacy results for MELT-300

SpyGlass Pharma announced completion of enrollment in its Phase I/II, randomized, multi-center, controlled clinical trial 

) evaluating SpyGlass’ drug delivery platform in patients with glaucoma or ocular hypertension.

According to the company, its platform is designed to deliver multiple years of bimatoprost to lower intraocular pressure (IOP) and is implanted during routine cataract surgery.

“Chronic eye conditions, such as glaucoma, can lead to vision loss and significantly impact quality of life. That’s why SpyGlass is singularly focused on making a difference for those in need,” said Patrick Mooney, SpyGlass Pharma’s CEO. “Completing enrollment in this study is an important milestone in our efforts to bring the SpyGlass technology to millions of patients around the world. We look forward to continued engagement with the FDA as we advance our platform toward two large Phase III trials.”

Malik Kahook, MD, co-founder of SpyGlass Pharma, noted the platform has demonstrated potential for improving care in glaucoma patients undergoing routine cataract surgery.

“As the SpyGlass platform is implanted using standard surgical techniques, it could significantly expand the integration of glaucoma treatment into routine cataract procedures,” Kahook said. “This could enhance adoption across a broad spectrum of surgeons and practices, setting our platform apart from currently available glaucoma interventions.”

Kahook also lauded the efforts of investigators and patients involved in the study.

“We are deeply grateful to the investigators and patients whose participation has been essential to advancing this clinical trial,” Kahook said. “Their trust and commitment have helped bring us closer to delivering a treatment that could significantly enhance care for glaucoma patients worldwide.”

The SpyGlass Drug Delivery Platform with bimatoprost is designed to deliver 3 years of bimatoprost to targeted tissues. SpyGlass will continue to release data from both the first-in-human study, which was recently published with 18-month data, and this Phase I/II study as it becomes available.

1. Spyglass Pharma, Inc. SpyGlass Pharma Completes Enrollment in Phase I/II Study of its Promising Long-Term Drug Delivery Platform for Glaucoma and Ocular Hypertension. GlobeNewswire News Room. Published November 19, 2024. Accessed November 19, 2024. https://www.globenewswire.com/news-release/2024/11/19/2983547/0/en/SpyGlass-Pharma-Completes-Enrollment-in-Phase-I-II-Study-of-its-Promising-Long-Term-Drug-Delivery-Platform-for-Glaucoma-and-Ocular-Hypertension.html

SpyGlass Pharma has completed enrollment for its Phase I/II clinical trial evaluating a drug delivery platform for glaucoma and ocular hypertension. The platform, designed to deliver bimatoprost over multiple years, is implanted during cataract surgery. This milestone is crucial for advancing the technology towards Phase III trials. The platform's integration into routine cataract procedures could enhance glaucoma treatment adoption. The company acknowledges the contributions of investigators and patients in the study, with ongoing data releases from the first-in-human and current trials.

SpyGlass Pharma completed enrollment in a Phase 1/2 trial evaluating its drug delivery platform for glaucoma and ocular hypertension. Designed for implantation during cataract surgery, the platform delivers bimatoprost to lower intraocular pressure for up to 3 years.

Theodore Leng, MD, MS

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