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Carl Zeiss Case Studies

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

iCare COMPASS Automated Perimeter

Clinical

1rem

Authors

Dr Varun Chaudhary presents the retreatment decisions during the treat-and-extend phase of the TENAYA and LUCERNE clinical trials in neovascular AMD, focusing on the percentage of patients who maintained, extended, or reduced their treatment interval based on visual and anatomic criteria.

Key Retreatment Decisions in the Clinical Trials for Faricimab in nAMD

Dr Varun Chaudhary discusses the impact of personalized treat-and-extend-based dosing on visual and anatomic outcomes of faricimab in the TENAYA and LUCERNE clinical trials in neovascular AMD.

Impact of Personalized Dosing of Faricimab on Treatment Outcomes in nAMD

Over the last 15 years, biosimilars have become a major feature of the health care landscape. Physicians in many disciplines, particularly oncology and immunology, have embraced biosimilars. However, access to educational resources on these powerful biologics can be inconsistent, and in turn, some ophthalmologists who could benefit from the adoption of biosimilars are left in the dark.

The real-world application of biosimilars was the focus of discussion for Martin Zinkernagel, MD, PhD, chair of the Department of Ophthalmology at the University Hospital of Bern, Switzerland, and Paolo Lanzetta, MD, professor of ophthalmology and chairman of the Department of Medicine-Ophthalmology at the University of Udine in Italy. In their discussion, the experts addressed several common questions, framed around the phase 3 clinical trial for biosimilar SB11 (BYOOVIZ) from Biogen. SB11 is approved in Europe and the United Kingdom. Like the reference product ranibizumab (Lucentis), SB11 is approved for the treatment of retinal disease including neovascular age-related macular degeneration (nAMD).

Addressing physicians’ levels of familiarity with biosimilars, Dr Lanzetta attributed much of the variation to regulatory discrepancies. “The uptake of biosimilars varies throughout Europe by country and by product,” he said. “Obviously, variation in the uptake of biosimilars [is] influenced by government involvement, reimbursement issues and tender procurement policies.” Recent survey data have revealed gaps in awareness across Europe and in the United States on the efficacy and safety of biosimilars for retinal diseases, Dr Lanzetta said, especially in terms of “real-world data.”

In a clinical application, Dr Lanzetta said, biosimilars may exhibit minor differences from the reference products, but they aren’t considered to have significant impact on the efficacy or safety profile. Typically, the biosimilar and reference medicine must have the same posology and route of administration, with few exceptions, he added.

Dr Lanzetta also said that in the last 10 years, the European Medicines Agency (EMA) has approved the highest number of biosimilars worldwide.

 “And this means, to us physicians, having both the possibility to have experience on their use in terms of safety and evaluating the efficacy after that,” he explained.

One common misconception about biosimilars is that these therapeutics are interchangeable with the idea of generic medicines. But there is a key indicator that biosimilars are unique: the cost. “While generic medicines are marketed at a significantly lower price than name brand ones, why do we not see the same level of cost savings with biosimilars?” Dr Zinkernagel asked.

Dr Lanzetta explained that biosimilars are developed via a rigorous, complex and highly regulated manufacturing process. “Generics are simple chemical medicines or agents, which is not the case for biosimilars and biologics,” he said. “Unlike generics, biologics, and therefore biosimilars as well, are very complex; they’re very difficult to copy. And the development processes are patented and proprietary to the originators.” The proprietary nature of biologic development, he added, is why biosimilars may have differences from their originators.

Prof Zinkernagel and Dr Lanzetta used data from the SB11 phase 3 trial to expand upon the capabilities of biosimilars. Prof Zinkernagel detailed the study: over 700 patients were included in the randomised, double-masked, parallel-group multicentre trial. Over 52 weeks, investigators evaluated the efficacy and the safety profile of this biosimilar SB11 in comparison with monthly ranibizumab for the treatment of nAMD.

“Patients with neovascular AMD were included, [with a] visual acuity range between 20/40 and 20/200,” Prof Zinkernagel said. “[Patients] were randomised in a 1:1 ratio to either have the originator or the biosimilar every 4 weeks from baseline up to week 48.”

Primary end-points were change from baseline in best corrected visual acuity at week 8 and change from baseline in central subfield thickness at week 4. The pre-specified secondary efficacy end-points included longer-term assessments of change from baseline in visual acuity, and the proportion of participants who lost fewer than 15 letters or who gained 15 or more letters in visual acuity from baseline at weeks 24 and 52.

“Other secondary end-points included, of course, change from baseline in central subfield thickness and central retinal lesion thickness at week 24, as well as change from baseline in choroidal neovascularisation [CNV] size and proportion of participants with active CNV leakage seen via OCT [optical coherence tomography] at week 24,” Prof Zinkernagel continued. Describing the results, he said, “When you look at the visual acuity improvements, it’s really equivalent. You have equivalence between the originator and the biosimilar, and the same holds true for a decrease in central retinal thickness. So the curves are basically the same, and also the secondary end-points.”

Prof Zinkernagel also spoke about the immunogenicity outcomes of the SB11 trial, as immunogenicity reactions have been a common problem in past assessments of anti–vascular endothelial growth factor (VEGF) agents. Along with detrimental effects to visual acuity, immunogenicity reactions can also lead to vasculitis and vitritis.

“Now, in this trial, the overall cumulative incidence of anti-drug antibodies, antibodies reacting against this specific drug up to week 52, was very low,” Prof Zinkernagel said. “For the SB11 biosimilar, it was 4.2%, and for the originator it was 5.5%. So very, very similar.”

He also noted that most antibodies were non-neutralising, which generally indicates a weak antibody response. “Furthermore, no statistical or clinically relevant differences in the incidence of anti-drug antibodies and neutralising antibodies were observed between treatment groups at any of the time points,” Prof Zinkernagel explained.

Dr Lanzetta highlighted the unique potentialities for anti-VEGF therapies as an area where physicians can consider treating patients with a biosimilar. “You can either switch a patient from the originator, obviously, or you can also consider treating with a biosimilar treatment-naive patients who may benefit…from being treated with that reference agent or originator agent,” he said. When to deploy a biosimilar will depend on many factors, including the locality where a patient is being treated. “Europe has different countries, different health care systems,” Dr Lanzetta said. “You may consider treating with the biosimilar patients who may not be strictly adherent to the cost of therapy and the frequency of treatment because of some cost issues.”

Just as education on biosimilars is vital to practitioners, awareness and education resources for patients are vital, too. “We spend a lot of time with our patients in letting them know that biologics did undergo a very rigorous approval process through studies, efficacy and safety studies,” Dr Lanzetta emphasised. This education is vital to getting patients on board with biosimilars, and it sparks enthusiasm about the potential benefits. “Once they do understand that, I think they will be very prone to receive a biosimilar; [it’s] in their interest and in the interest of the community, the whole community of patients, and in the interest of the health care system,” Dr Lanzetta said.

1. Biosimilars in the EU: information guide for healthcare professionals. European Medicines Agency. Updated December 2, 2019. Accessed October 3, 2023. 

https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pd

Editor’s note: A prior version of this article contained a misspelling of the product name BYOOVIZ. It has been corrected. We regret the error.

How biosimilars expand treatment options for patients with retinal disease

For a patient undergoing cataract surgery, the primary post-operative expectation is improved vision. As a surgeon, achieving the desired refractive outcome involves several critical steps: conducting precise preoperative measurements, selecting the appropriate IOL technology and power, and performing surgery with accuracy. 

Heidelberg Engineering’s advanced diagnostic imaging solutions support you in enhancing the cataract patient journey, from initial assessment and diagnosis to preoperative planning and postoperative monitoring. Throughout this interactive supplement, leading surgeons share their experiences with and discuss the advantages of these advanced diagnostic imaging solutions, as Dr. James Lewis does in this video 

A major challenge for cataract surgeons is the vast number of patients. Addressing this backlog is crucial to prevent vision impairment and improve the quality of life for those affected. The electronic medical record, Heidelberg Eye Explorer 

, helps to streamline the cataract workflow by optimising patient data management, enhancing communication, and improving surgical planning.

Dr. Hackle from Hanusch Hospital in Vienna recalls how HEYEX EMR streamlined their workflow and provided access to patient records across more than five locations.

“There was a need to have a paperless medical record which could be seen in all five locations and met our main requirements: a continuous medical record, a patient summary for a quick overview, as well as planning and documentation…when a system like HEYEX EMR supports structured data the possibilities to use the data are unlimited." 


Read the full story on how Hanusch Hospital, Vienna, used HEYEX EMR to streamline their workflow.

 image and data management platform into your clinic workflow allows for improved efficiency. All patient information is centrally recorded and can be accessed anywhere in the clinic. Images and data are immediately available on your desired device, viewing station, and in the patient record.

Visualising all relevant data and images from the cataract workup contributes to an optimal diagnostic workflow, facilitates confident decisions, and assists you in easily identifying potential sources of complication.

Precise ocular biometry is critical for determining the power of IOLs being implanted. Leveraging advanced Swept-Source OCT technology, 

 provides you with a comprehensive, all-in-one solution for optical biometry and IOL power prediction. In a single imaging session, the Cataract App provides precise and accurate measurements traditionally delivered by several devices, including axial length, cornea topography and tomography, anterior chamber depth, lens thickness, white-to-white, and central corneal thickness.

“I was looking to upgrade my methods and equipment, especially in intraocular lens calculation, explains Dr Arturo Chayet, ophthalmologist and founder of CODET Vision Institute in Tijuana, Baja California, Mexico. At the time, I was using the IOLMaster500 for calculations, but I was looking for a bridge to swept-source OCT technology. We knew it was crucial to not only measure axial length and various parameters of the eye but also to understand the anterior chamber, specifically the effective lens position. I was struck by the capability of ANTERION and was very impressed with the expertise Heidelberg Engineering has in the field. Our experience with SPECTRALIS was excellent as well.” 
- Dr. Arturo Chayet, M.D. 

For refractive IOL procedures, where presbyopia-correcting IOLs are implanted, and in challenging cases, accessing additional data is essential for patient selection and satisfaction. ANTERION provides a comprehensive analysis of the cornea and includes details on astigmatism and corneal wavefront. 

Learn more about the significant role ANTERION plays in premium IOL selection here.

ANTERION’s high-resolution imaging of the anterior segment can help you prevent unexpected results by identifying complex ocular properties relating to anatomy, visual quality, and atypical geometry of the anterior segment. The high-quality images also provide visual aids that can be used to explain your patient’s condition and the planned surgical procedure, enhancing their understanding and compliance.

Listen to Dr. Pooja Kumar, Consultant, Khetarpal Hospital, New Delhi, India 

, as she explains how she uses ANTERION’s high-resolution swept-source OCT images to identify complex cases like posterior polar cataracts. She also explains how she utilizes these images to counsel her patients in preparation for surgery.

OCT imaging of the retina before cataract surgery lets you assess pathologies that may limit visual outcomes. 

 allows you to choose between 20kHz, 85kHz and 125KHz depending on your needs. 20 kHz scan speed offers high-quality retinal imaging also in eyes with media opacities often caused by cataracts. 

Read more about the benefits of retinal OCT before cataract surgery here

 provides a comprehensive overview by combining data and images from all devices 

. This consolidated information ensures you have all relevant diagnostic details, enhancing your confidence in surgical planning.

 delivers next-generation image technology to revolutionise your surgical practice. It brings together innovative design and 3D technology to set new standards in surgical precision and surgeon comfort during procedures.

 as he shares his initial impressions and discusses the benefits of SeeLuma, explaining why he eagerly anticipates incorporating it into his practice soon.

High-Resolution Imaging for Postoperative Evaluation

 supports you in visualising the success of surgical procedures by comparing pre- and post-op images and measurements. Detailed anterior chamber information from high-resolution SS-OCT images helps you assess cataract surgery outcomes, including IOL placement, ensuring optimal patient care and satisfaction 

Watch this Healio video interview with Dr. Mitchell W. Dul, OD, 

where he explains how he uses the ANTERION Metrics App to show his patients their pre-op and post-op configurations, helping them become more invested in their care.

Leveraging Heidelberg Engineering's advanced diagnostic tools and technologies, including high-quality OCT imaging, precise biometry, and corneal topography and tomography, enhances your diagnostic accuracy, surgical planning, and postoperative evaluation. Whether dealing with standard, refractive IOL, or challenging cases, these tools and technologies can help you improve patient outcomes and engagement, streamline workflows, and flag potential surgical complications.

Enhancing the Patient Journey: Solutions for Streamlining Success in Cataract Surgery

Glaucoma specialists worldwide face numerous challenges daily, from early detection to accurate diagnosis and ongoing patient management. The Heidelberg Engineering Glaucoma Workflow Solution is designed to provide the tools you need to deliver the best care to your patients. It offers dynamic visualization of parameters, efficient data management, precise imaging, and robust monitoring capabilities. Find out how glaucoma experts around the world are leveraging these advanced technologies to enhance the patient journey, increase diagnostic confidence, streamline workflows, and improve patient outcomes.

“It was a surprise as I didn’t feel my vision had been hindered in any way. At that point, I didn’t know that glaucoma was rampant in my family on both my mother’s and father’s sides. When I shared the news of my glaucoma with my late mother, she did not miss a beat, replying, ‘Oh honey, your father and I have had glaucoma for years’. To which I could only say, ‘Really Mom, maybe you and Dad could’ve mentioned that […] like 20 years earlier.” PHILLIP VAN LEAR, diagnosed at 48 

One of the most significant challenges in glaucoma management is detecting the disease early, as it often progresses without symptoms. “

Early glaucoma has no symptoms,” explains Christian Mardin, Consultant Ophthalmologist at Friedrich-Alexander-Universität, Erlangen, Germany. “Every person over 40 should go to their optometrist or ophthalmologist to get their optic nerve head checked

Continue reading Prof. Mardin’s insights on early glaucoma detection here.

The electronic medical record platform HEYEX EMR helps streamline this process by managing and presenting comprehensive ophthalmic patient records through an intuitive interface. It provides access to high-quality, structured data, aiding in efficient reporting and auditing. Dr. Hackle of Hanusch Hospital, Vienna, recalls how HEYEX EMR helped the hospital streamline their workflow and allowed access to patient records in over five locations.

“There was a need to have a paperless medical record which could be seen in all five locations and met our main requirements: a continuous medical record, a patient summary for quick overview, as well as planning and documentation…when a system like HEYEX EMR supports structured data the possibilities to use the data are unlimited.

Read the full story on how Hanusch Hospital, Vienna, used HEYEX EMR to streamline their workflow.

As early detection becomes more efficient, the next step is ensuring accurate diagnosis, where the 

The Glaucoma Module Premium Edition (GMPE)

 provides detailed imaging and analytics of the optic nerve head and retinal nerve fiber layer. Using the Anatomic Positioning System (APS) ensures an accurate anatomical setup for optimal comparison with the normative reference database. These tools equip you with the information needed to support confident diagnostic decisions. 

Download the SPECTRALIS Glaucoma Toolkit here.

 allows for non-contact assessment of iridocorneal angles and anterior segment anatomy, providing precise measurements and automatic identification of the scleral spur to enhance your early detection capabilities. 

Dr. Benjamin Xu, Chief of the University of Southern California's Glaucoma Service, presents a webinar on using non-invasive anterior segment imaging, including ANTERION® technology and AI, to detect and treat angle closure glaucoma. 

Once a confident diagnosis is achieved, effective management relies on seamless referrals and data sharing, which is where the integration of HEYEX EMR with the 

 platform becomes indispensable. Effective glaucoma management necessitates streamlined referrals and data sharing throughout your clinic. This system centralizes patient information, minimizing duplication and manual data entry errors.

HEYEX 2 Cloud Exchange facilitates secure, peer-to-peer transfer of images and data over the internet, eliminating the need for VPN connections. This feature enables efficient and encrypted data transfers, ensuring timely communication with other healthcare providers and enhancing your referral process. Learn to start using Cloud Exchange and transfer data after setting it up on 

 enhances your diagnostic workflows by enabling side-by-side review of images and reports from both eyes, consolidating all pertinent data for comprehensive analysis, in one single view.

“I have chanced upon signs which masquerade as glaucoma on an OCT scan. Branch retinal artery occlusions or cotton wool spots — small infarcts or blood vessel closures — can result in an initial swelling in the nerve fibre layer. They are transient and disappear in a few weeks, and are often caused by high blood pressure or kidney disease.” 

PROF. SANJAY ASRANI, Duke Eye Center, North Carolina, USA 

Accurate glaucoma diagnosis hinges on comprehensive examination techniques. The SPECTRALIS GMPE provides accurate measurements and visualization of key parameters involved in glaucoma diagnosis such as the optic nerve head, retinal nerve fibre layer, and macular ganglion cell layer, via OCT imaging. Tools like Bruch’s Membrane Opening – Minimum Rim Width (BMO-MRW) offer objective, geometrically accurate measurements of the neuro-retinal rim, aiding your early detection efforts. The reference database further guides your analyses.

Learn to integrate the power of OCT imaging and SPECTRALIS GMPE in your daily practice in this educational webinar by Dr. Swarup Swaminathan. 

Sometimes glaucoma needs to be differentiated from other conditions with similar presentations. Recognizing these nuances ensures your accurate diagnosis and effective treatment planning.

Regular monitoring is critical for managing glaucoma patients. The HEYEX 2 Multimodality Viewer supports ongoing data sharing and displays follow-up examinations across multiple locations, allowing you to access previous images and reports easily. Post-surgery, the ANTERION Metrics App provides precise measurements and visualizations of the anterior chamber and the anterior chamber angle, crucial for effective patient management.

Integration with the SPECTRALIS core technologies, such as TruTrack Active Eye Tracking and AutoRescan, ensures accurate monitoring of disease progression. These tools enable follow-up scans in the exact anatomical locations as previous exams, allowing you to detect minute changes with high precision.

, the world's first fully digital microscope, offers unparalleled precision through its 3D visualization technology. It provides exceptional image quality, ergonomics, and educational features, significantly benefiting your surgical practice.

The Heidelberg Engineering Glaucoma Workflow Solution is designed to integrate seamlessly into your patient care routine, supporting unparalleled diagnostic confidence and efficiency. By leveraging these advanced tools and technologies, you can overcome the challenges in glaucoma management, improving patient outcomes and engagement.

Delve deeper into how these solutions can transform your practice.

Enhancing the Patient Journey: Solutions to Overcoming Challenges in Glaucoma Management


As a young ophthalmologist in my early years of practice, I am always asking myself, how I can do my best for my patients. Improving my skills in performing cataract surgery has been one area of focus for me, and there are a variety of modalities that I could consider to help me achieve my goal. The ZEISS Surgery Optimizer offers a new option, and I was excited when I was asked to trial it in my practice.

Cataract surgeons certainly know that reviewing personal intraoperative videos is a useful method for improving efficiency and skill because it allows us to see what we are doing well and identify areas where there is room for improvement. In addition, watching recordings from surgeries performed by recognized experts can be a powerful learning tool. Based on the concept of “monkey see, monkey do”, the hope is that after observing cases done by the hands of leading surgeons, we will be able to replicate their tricks and techniques and improve our skills.

The process for reviewing intraoperative videos requires that surgeons have a good microscope, a good recording system, and technology for transferring and watching the videos. Surgeons operating in modern facilities have access to the first two components of this triad, but exporting the recordings to a device where they can be reviewed has been a cumbersome, multistep task that discouraged surgeons from taking advantage of the benefits that could be gained from video review. Once recorded, the video file needs to be transferred to a USB drive and then to a desktop or laptop computer, but that transfer could be slow and time consuming considering the large size of the video files.

The ZEISS Surgery Optimizer revolutionizes the entire process by providing a way for surgeons to access their surgical videos anytime on their personal devices without having to manually export and import the files. With the click of a button, videos are imported from ZEISS CALLISTO eye, a digital navigation and data management system of ZEISS ophthalmic microscopes, to a cloud-based software system. Once imported, the videos are directly available for viewing on a computer via a web browser or on a mobile device using the dedicated ZEISS Surgery Optimizer app (VIDEO 1). Case documentation and database creation are easy, enabling surgeons to be selective about what videos they add to the application. The descriptive documentation also has the benefit of enabling searching for cases based on specific characteristics, such as biometry measurements.

Importantly, the app also gives users access to unedited videos provided by highly experienced surgeons from countries all around the world with the opportunity to review those recordings side by side against their personal videos so that they can learn by comparing their own techniques against those of leading surgeons.


Video 1: Reviewing your surgical performance with ZEISS Surgery Optimizer


Tabs on the opening page of the ZEISS Surgery Optimizer screen show available videos divided into 3 categories: 1) Institution cases, which are cases performed at the user’s institution; 2) Featured cases, which represent a video gallery of cases from leading surgeons around the world; and 3) Favorites, which are institution cases individual users have chosen for easy access.

The videos are supported with datasets from ZEISS integrated devices, such as IOLMaster 500 and 700, and when a selected video plays, the patient’s biometric and some other preoperative data are displayed on the lefthand side of the screen. Using an AI-based segmentation algorithm, the ZEISS Surgery Optimizer automatically divides each case into its multiple phases (ie., incision, OVD injection, capsulorhexis, hydrodissection, phacoemulsification, irrigation/aspiration, IOL implantation, etc). As a very useful feature, the phases appear both as a list on the lefthand side of the screen and below the video timeline so that with a single click, surgeons can advance the video to focus on a particular maneuver. To designate a video as a “favorite”, users click on a star that appears at the righthand bottom corner of the screen, and a tab in the upper righthand corner gives users the capability to compare their case with a featured case. The cases chosen for comparison play side by side and can be watched from the beginning or at any selected phase. Users can adjust brightness, contrast, and playback speed without downloading the video. Videos can also be downloaded for editing with a professional software program.

My personal experience using the ZEISS Surgery Optimizer is testament to the appropriateness of its name. In a series of 200 routine cases that I performed before using the app, my total surgical time averaged about 12 to 13 minutes. Over a period of 30 days, I reviewed my videos using the app and compared them with selected “featured” videos to see where I could improve my techniques and increase my efficiency for completing various steps in the procedure (Video 2). I chose cases from my mentor, Dr Sri Ganesh, as my featured cases. I knew that Dr Ganesh completes a routine cataract surgery case in about 2.5 minutes, which left me eager to see what he does differently. My goal was not simply to increase my speed, but rather to improve my skills. Dr Ganesh always advised me that I should focus on the economy of movements and surgical efficiency and that faster speed would follow as a happy coincidence. He was right!

Watching his videos side-by-side with mine, I identified multiple ways to improve my approaches for completing a variety of steps. In particular, I implemented new techniques for performing capsulorhexis, hydrodissection, and direct chop/phacoemulsification, and I was amazed by the impact my time spent with the application had on reducing my average case time. Analyzing cases performed in my “post Surgery Optimizer era”, I found that I had cut my average surgical time by about 50% to just 6.5 minutes compared to my “pre Surgery Optimizer era”, I found that I had cut my average surgical time by about 50% to just 6.5 minutes compared to my “pre Surgery Optimizer era”. The largest contributors to this change were decreases in my average times for capsulorhexis (40 to 27 seconds), hydrodissection (40 to 9 seconds), and direct chop/phacoemulsification (3 minutes 10 seconds to 1 minute 52 seconds).

Video 2: AI driven comparison of the own surgical performance with expert-level cases

I believe that my experience with the ZEISS Surgery Optimizer is compelling proof of how this tool can help young ophthalmologists refine their cataract surgery skills and efficiency. In addition, I am certain that it has value as a remote teaching tool for residents and fellows and can help these ophthalmologists-in-training shorten their cataract surgery learning curve.

According to my mentor, Dr Ganesh, the ZEISS Surgery Optimizer can also be a useful tool for surgeons training young ophthalmologists because it enables mentors to evaluate current skills and provide guidance for modifications. Furthermore, I expect that experienced cataract surgeons wanting to implement a new technique can accelerate their learning phase by using the application.

The AI- and cloud-based ZEISS Surgery Optimizer provides cataract surgeons in practice and ophthalmologists in training an innovative new way of utilizing surgical videos. It allows users quick and easy access to the material at any time and on any personal device they choose along with the opportunity to review their procedures and compare their techniques directly with those of leading surgeons. Based on my personal experience with this self-training tool, I am convinced of its value and highly recommend its use by anyone wanting to take their cataract surgery skills to the next level.

Dr Supriya Samak Sriganesh is an ophthalmologist on staff at Nethradhama Super Specialty Eye Hospital, Bangalore, India, specializing in cataract and refractive surgery. Dr Sriganesh is a consultant of ZEISS.

The statements of the author reflect only her personal opinion and experiences and do not necessarily reflect the opinion of any institution that she is affiliated with. The author alone is responsible for the content of her experience reported and any potential resulting infringements. Carl Zeiss Meditec AG and its affiliates do not have clinical evidence supporting the opinions and statements of the author nor accept any responsibility or liability of the author's content. Surgery Optimizer is a non-medical device and not intended for diagnosis and therapeutic purposes, only for education, learning & review purposes

Upgrading cataract surgery skills –  Unlocking the full potential of surgical video review using an AI-based application

The reduction in near and intermediate visual acuity (VA) associated with presbyopia presents particular functional challenges for commercial pilots whose work mandates the ability to see clearly at multiple distances from near to far and under a variety of conditions that can create glare and decrease contrast. Highlighting the importance of the impact of presbyopia on visual function for pilots are data indicating that airline pilots are a “graying” population with an average age of about 44 years among European pilots and even older among those in other global regions.

To achieve medical certification for flying, commercial airline pilots must meet rigorous visual performance standards, including for VA at all distances. ZEISS PRESBYOND

 (Carl Zeiss Meditec AG; Jena, Germany) is a binocular corneal approach to manage presbyopia that has the ability to successfully meet the complex visual demands of presbyopic pilots whether hyperopic

. Performed using a software option for the ZEISS CRS-Master

 90 excimer laser (all Carl Zeiss Meditec), ZEISS PRESBYOND increases depth of field by inducing a controlled amount of spherical aberration. The surgeon is correcting the dominant eye for far and the non-dominant eye for near, creating an anisometropia of up to 1.5 D, depending on the tolerance of the patient. The result is the creation of a blend zone that affords patients continuous vision over a range of distances. The small inter-eye difference in refraction that is present after ZEISS PRESBYOND is well-tolerated by most individuals and does not affect stereoacuity. Furthermore, because ZEISS PRESBYOND creates a continuous aspheric profile on the cornea rather than multifocality, patients maintain good contrast sensitivity and visual quality. As published in numerous peer reviewed journals, the clinical results achieved with ZEISS PRESBYOND in patients treated at our center and by other surgeons provide evidence that it is a safe, well-tolerated, effective method for treating presbyopia with high accuracy, stability, adjustability and, if needed, reversibility.

Since 2012, many commercial and military pilots have been treated with ZEISS PRESBYOND at our London Vision Clinic. One of the earliest individuals in this series was Eleanor Ivory, MD, who worked for British Airways as both a commercial airline pilot and Aeromedical Examiner (AME) whose job entails conducting examinations for granting pilot medical certification. Dr Ivory had worn contact lenses to correct myopia since her early teens. Wanting to explore vision correction options other than readers or varifocal glasses for achieving spectacle independence, Dr Ivory presented at age 53 to the London Vision Clinic in 2013. On assessment, her refraction was -3.50 -0.50 x 146 OD and -2.25 -0.75 x 10 OS, and she was deemed an appropriate candidate for a LASIK procedure. After counselling about the risks, benefits, and alternatives, Dr Ivory was treated using ZEISS PRESBYOND software with her dominant right eye targeted for far (plano refraction) and her left eye for near (-1.50 DS).

At 1 month after surgery, Dr Ivory’s binocular uncorrected VA was 20/16-1 at distance, J3 at intermediate, and J1 at near. She received Class 1 medical recertification without glasses restrictions from the United Kingdom Civil Aviation Authority at 8 weeks postop, and review of data collected at return visits over the next 8 years show that her refraction and binocular VA values were stable long-term. Moreover, at 10 years after surgery, Dr Ivory remains exuberant about her outcomes and an ardent advocate for ZEISS PRESBYOND.

Over the years, feedback from the numerous pilots treated with ZEISS PRESBYOND indicates that the recorded VA results correspond with improved ability to perform the full range of their occupational vision-related tasks. However, we wanted to formally document the subjective benefits of ZEISS PRESBYOND for pilots and approached Dr Ivory for help developing a questionnaire. After reviewing the presenting complaints and motivational factors expressed by pilots who had presented for laser refractive surgery assessment, Dr Ivory in collaboration with two other commercial airliner pilots designed a 16-item questionnaire.

The questionnaire asked pilots to rate their ability or comfort with tasks before surgery with glasses and after surgery without glasses. It was sent to 23 pilots who had undergone ZEISS PRESBYOND at least 12 months earlier and was completed by 18 pilots. All of the responding pilots received Class 1 medical recertification from the UK Civil Aviation Authority within 2 to 8 weeks after ZEISS PRESBYOND, which speaks to the speed of visual recovery after the surgery and the efficacy of the treatment. Notably, all pilots had binocular uncorrected VA of 20/20 or better at distance and J2 or better at near, and 17 of the 18 pilots achieved J5 or better binocular uncorrected intermediate VA. Eleven pilots (61%) achieved medical recertification without any spectacle requirement or restriction, and the others were recertified with a limitation indicating glasses, including a spare pair, shall be kept readily available in the cockpit if required. Notwithstanding the conditions of their certification, 15 of the 18 pilots (83.3%) reported being able to perform 100% of their vision-related tasks without glasses. In addition, analyses of the data collected in the questionnaire showed that the group achieved statistically significant improvements after surgery in their performance of various tasks as well as in eye comfort (Figure 1). An overall satisfaction score calculated from the data also improved, increasing from a mean of 3.32 ± 0.3 before surgery with glasses to 4.57 ± 0.20 after surgery without glasses, which is very close to the best possible score of 5.0.

ZEISS PRESBYOND is a safe, efficient, and effective LASIK-based procedure for providing spectacle-independence to presbyopic patients in the absence of cataract. Results from published studies world-wide show that ZEISS PRESBYOND delivers excellent vision at all distances without causing loss of contrast or dysphotopsia.

 In addition, patient-reported outcomes data show high levels of satisfaction, including among pilots who face complex visual demands within a challenging environment.

Knowledge that the results of ZEISS PRESBYOND satisfy pilots who represent a highly demanding group should give refractive surgeons confidence that this binocular LASIK-type procedure can be a great option to consider for the large and growing population of patients who do not yet have cataract and are interested in solutions for their presbyopia.

Reflections of an Aeromedical Examiner “laser eye surgery expert”

I began wearing contact lenses to correct myopia at age 14, and the desire not to wear glasses once I became presbyopic prompted me to research laser eye surgery as a solution to requiring reading glasses.

Undergoing PRESBYOND blended LASIK was a life-changing event for me. I was thrilled that after the surgery I was able to see clearly at all distances without glasses, and a decade later, I still have virtually perfect vision without correction.

Using varifocal glasses to manage presbyopia suits many pilots, but wearers of these aids can be challenged to find the right tilt of the head to look through the correct part of the glasses. In contrast, I experience no delay in accommodation between the various focal distances that pilots are required to rapidly transition through.

As clearly highlighted by the results of the pilot survey, freedom from requiring glasses after PRESBYOND has benefit for several routine flight deck tasks. Strikingly, the survey showed a particular impact in the RARE event where a pilot would have to don a flight oxygen mask or smoke hood. A benefit of PRESBYOND in terms of flight safety also became apparent to me after I had the procedure.

Because I personally underwent LASIK, I am considered “the laser eye surgery expert” in my role as an AME. When approached by pilots interested in refractive surgery for presbyopia, I tell them that PRESBYOND has been a miracle procedure for me, and I recommend it without any hesitation.

Dr Ivory has no relevant financial interests to disclose.

Statista. Average age of airline pilots in 2016, by region. https://www.statista.com/ statistics/739969/average-age-of-airline-pilots/#:~:text=Airline%20pilots%20in%20the%20Americas,average%20age%20of%2043.7%20years. Accessed September 25, 2023.

Russo A, Reinstein DZ, Filini O, et al. Visual and refractive outcomes following laser blended vision with non-linear aspheric micro-anisometropia (PRESBYOND) in myopic and hyperopic patients. J Refract Surg. 2022;38(5):288-297.

Reinstein DZ, Couch DG, Archer TJ. LASIK for hyperopic astigmatism and presbyopia using micromonovision with the Carl Zeiss Meditec MEL80 platform. J Refract Surg. 2009;25(1):37-58.

Reinstein DZ, Archer TJ, Gobbe M. LASIK for Myopic Astigmatism and presbyopia using onlinear aspheric micro-monovision with the Carl Zeiss Meditec MEL 80 platform. J Refract Surg. 2011;27(1):23-37.

Reinstein DZ, Carp GI, Archer TJ, Gobbe M. LASIK for the correction of presbyopia in emmetropic patients using aspheric ablation profiles and a micro-monovision protocol with the Carl Zeiss Meditec MEL80 and VisuMax. J Refract Surg. 2012; 28:531-541.

Reinstein DZ, Ivory E, Chorley A, et al. PRESBYOND Laser Blended Vision LASIK in commercial and military pilots requiring class 1 medical certification. J Refract Surg. 2023;39(1):6-14.

Ganesh S, Brar S, Gautam M, Sriprakash K. Visual and refractive outcomes following laser blended vision using on-linear aspheric micro-monovision. J Refract Surg. 2020;36(5):300-307.

Professor Dan Z. Reinstein, MD MA(Cantab) FRCSC DABO FRCOphth FEBO

 is Medical Director of the London Vision Clinic, London, England. He is a consultant for Carl Zeiss Meditec AG (Jena, Germany) and has a contractual or other financial relationship with Carl Zeiss Meditec AG and its affiliates and has received financial support.

Spectacle independence for presbyopic patients: Achieving success and satisfaction with ZEISS PRESBYOND, even in a highly demanding cohort

I opened my own refractive surgery practice in Perth, Australia in 2019, and when getting started I was mostly performing LASIK in pre-presbyopic patients. Perth is the fourth largest city in Australia but is the most competitive regarding refractive surgery. For instance, the number of centers offering lenticule extraction surgery is greater in Perth than in Sydney and Melbourne combined. To set myself apart from other centers, I saw a potential for practice building by offering solutions for presbyopia in patients without cataract, as this is a huge patient group whose special needs are currently not addressed by all clinics. My theory proved to be correct because within a few years, the latter group became a significant segment of my practice, accounting for about 35% of the total share.

Like most surgeons in Australia, I was performing refractive lens replacements (RLR) with multifocal IOL implantation to manage presbyopic patients without cataract, despite the disadvantages and risks of that approach.1 I tried a multifocal corneal approach but stopped after 9 patients because the results were far below my and my patients’ expectations.

In June 2022 I traveled to London, UK, to take the London Vision Clinic’s Forefront Refractive surgery course led by Prof. Dan Z. Reinstein and Mr Glenn Carp. My primary purpose for attending the program was my interest in augmenting my surgical portfolio for corneal refractive surgery with Lenticule Extraction (LE). The course also covered PRESBYOND from ZEISS, a corneal solution for treating presbyopic patients that differed from anything I had known before. I was intrigued by Prof Reinstein’s description of the results and benefits of PRESBYOND® and saw it as a great opportunity to meet the needs of my younger presbyopic patients without cataract seeking spectacle independence and to expand my practice.

PRESBYOND® is a software for planning a customized binocular LASIK procedure to both manage presbyopia and correct refractive error. It increases the depth of field by inducing a controlled amount of spherical aberration and creating a micro-anisometropia (≤1.5 D), the latter being well-tolerated by most patients. Studies have shown that up to 97% of presbyopic patients tolerate the micro- anisometropia.2 PRESBYOND® gives patients a continuous range of quality vision from near to far, has the accuracy of a laser refractive procedure, and avoids the drawbacks that accompany other methods used for surgical management of presbyopia like glare and haloes at nighttime. Importantly, patients treated with PRESBYOND® maintain stereoacuity and contrast sensitivity.

I began performing PRESBYOND® in September 2022, and it did not take long before it proved itself to be a valuable addition to my surgical armamentarium. Not only did the outcomes I was achieving show me that by implementing PRESBYOND® I had made the right decision for my patients, but reviewing my surgical volumes and center’s revenues, I knew that I had also made a fantastic business decision for my practice.

I recently analyzed visual acuity outcomes for my first 41 PRESBYOND® cases that comprised a mix of myopic and hyperopic patients. Subjective reports showed most patients were spectacle independent. No patient needed reading glasses, although some patients said they benefited from wearing glasses at certain times, especially for night driving. No patient lost ≥2 lines CDVA and no one was unhappy.

The analysis of my caseload and case distribution data showed that my total surgical volume increased more than 41% comparing the same 9-month period (Sept – May) from before and after I implemented both PRESBYOND® and LE with SMILE® (Figure).

Although both PRESBYOND® and SMILE® contributed to the increase, PRESBYOND® was the primary driver, largely accounting for a more than doubling of my total presbyopic treatments, which went from 82 to 166. Furthermore, after introducing PRESBYOND®, treatment for presbyopia in patients without cataract came to represent a majority of my procedures, accounting for 51% of my steadily growing clinic volume. The number of RLR procedures I performed dropped drastically since PRESBYOND® has become my first choice for younger presbyopic patients without cataract. Now I only perform RLR in occasional cases when a specific patient is not suitable for a LASIK procedure.

Equipment, training and marketing – What it took to get started

When I returned from Prof Reinstein’s course, I sold my excimer laser and ordered both the MEL® 90 excimer laser and the VISUMAX® 800 femtosecond laser.

In addition to having the necessary equipment for PRESBYOND®, it is also very important for surgeons to prepare themselves and their staff and to adapt the clinic’s workflow accordingly. While waiting for the delivery of my new lasers, my staff and I worked tirelessly to prepare for successful PRESBYOND® implementation. Attending Prof Reinstein’s course was essential for giving me the necessary foundation. Then my staff and I watched and rewatched video course material, and my optometrist and I practiced to both perfect our specific refraction skills needed for PRESBYOND®, and to refine our counseling conversations for potential patients.

Surgeons who are performing LASIK will find that the learning curve for the procedure itself is very short, since it is basically a LASIK procedure. In my opinion, however, one must first have a thorough understanding of the theory and working principle of PRESBYOND® along with knowledge of the components of the screening evaluation and preoperative workup that are essential for proper patient selection and surgical planning. Most patients are suitable candidates for PRESBYOND®, and accurate preoperative measurements are critical for customized planning of the ablation that is best for all individuals.

It had been suggested to perform at least 50 LASIK procedures with the MEL 90 from ZEISS to achieve very good clinical outcomes with LASIK patients and if necessary fine tune nomograms before beginning to use the laser for PRESBYOND®. Because I was obtaining such predictably accurate outcomes with MEL® 90 for my LASIK patients, I was able to introduce PRESBYOND® within 1 month.

Initially, I was marketing PRESBYOND® to consumers and referring eye care practitioners quite extensively. I recommend that surgeons starting out with ZEISS PRESBYOND do the same to set their practice apart from others. I had articles and advertisements placed in local newspapers and held continuing professional development meetings for optometrists and general ophthalmologists. During those meetings I had patients share their experience because I thought their success stories would be more convincing than my lecturing. I also offered PRESBYOND® to optometrists and general practitioners, confident that these practitioners would become satisfied patients and a lifelong source of referrals. In fact, my practice benefits from a wide referral base, and is now the prime center in Perth for surgical management of presbyopia. My success with PRESBYOND® now draws patients to my practice through word-of-mouth referrals, and our need to advertise the procedure has significantly decreased.

Addressing the needs of presbyopic patients has definitely been one of the best decisions for my practice. However, as reflected by my surgical volume data, the real game changer has been the switch from my original RLR approach to the corneal approach with PRESBYOND® as my procedure of choice for this large pool of potential patients. The functional results I am achieving with PRESBYOND® speak for themselves in confirming that it is a safe and effective procedure for managing presbyopia in patients with myopia4, hyperopia5, and emmetropia2. Moreover, the dramatic effect that “word of mouth” referrals are having on my practice growth is testament to the high level of patient satisfaction.

The trust in my gut feeling and the commitment of my team certainly had important roles in leading me along the path to “Infinity and PRESBYOND®”. But, implementing PRESBYOND® and being successful also involves investment and effort. The MEL® 90 laser and refractive workplace station with the PRESBYOND software from ZEISS are requisite. In addition, the surgeon and staff must become well-versed in the principles of PRESBYOND®, components of the screening evaluation, preoperative work-up, and elements of proper patient education. In closing, I hope that my experience with PRESBYOND® might motivate its adoption by other surgeons because I firmly believe that just like me, they will find benefit both for themselves and their patients.

, MBChB is medical director and founder of the Crystal Eye and Laser Centre, Perth, Australia. He is a paid consultant to Carl Zeiss Meditec.

1. Alvarado-Villacorta R, Hernandez-Quintela E, De La Torre-Gonzalez E, Loza Munárriz C, Martinez- Zapata MJ. Surgical interventions for presbyopia (Protocol). Cochrane Database of Systematic Reviews. 2023, Issue 3. Art. No.: CD015711.

2. Reinstein DZ, Carp GI, Archer TJ, Gobbe M. LASIK for the correction of presbyopia in emmetropic patients using aspheric ablation profiles and a micro-monovision protocol with the Carl Zeiss Meditec MEL80 and VisuMax. J Refract Surg. 2012; 28:531-541.

3. Brar S, Sute SS, Bagare SN, Ganesh S. Functional outcomes and reading speeds following PRESBYOND LBV using nonlinear aspheric ablation profiles combined with micro-monovision. J Ophthalmol. 2021;2021:2957443.

4. Reinstein DZ, Archer TJ, Gobbe M. LASIK for Myopic Astigmatism and presbyopia using onlinear aspheric micro-monovision with the Carl Zeiss Meditec MEL 80 platform. J Refract Surg. 2011;27(1):23-37.

5. Reinstein DZ, Couch DG, Archer TJ. LASIK for hyperopic astigmatism and presbyopia using micromonovision with the Carl Zeiss Meditec MEL80 platform. J Refract Surg. 2009;25(1):37-58.

Varun Chaudhary, MD, FRCS(C)

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