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For retinal specialists grappling with diseases once thought “untreatable,” gene therapies present a wide range of viable options

Inherited retinal diseases and gene therapies: A pharmaceutical overview

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

Hyperopic treatments have long been a topic of debate, with corneal-based options often pushed aside in favor of intraocular lenses (IOLs). However, recent advancements have reignited interest in corneal laser treatments, particularly with the evolution of LASIK and the introduction of Lenticule Extraction for hyperopia. Officially launched at the ESCRS Barcelona 2024, ZEISS SMILE pro for hyperopia is available as a new application on the ZEISS VISUMAX 800 femtosecond laser platform.

The implementation of SMILE pro for hyperopia on the VISUMAX 800, ZEISS Medical Technology’s most advanced laser system, marks a significant milestone in hyperopia treatment. This breakthrough in hyperopic treatment has shown outcomes comparable to hyperopic LASIK, while offering key benefits of ZEISS SMILE and SMILE pro such as minimized dry eye symptoms and reduced aberration induction.

Step-by-step to success - The journey of Lenticule Extraction for hyperopic patients

While ZEISS SMILE has been successfully used for myopia for years, hyperopic treatments faced initial setbacks, particularly with early prototypes like FLEx (Carl Zeiss Meditec AG), which lacked effective transition zones and used small optical zones. These early designs resulted in poor visual quality and unacceptable levels of regression, causing many to question whether Lenticule Extraction could ever be a viable option for hyperopia.

However, by redesigning the lenticule geometry to include an expanded transition zone and a larger optical zone, ZEISS SMILE pro has become an effective alternative to LASIK for hyperopia. The final lenticule geometry consisted of an optical zone of 6.3 mm with a transition zone of 2 mm, corresponding to a total lenticule diameter of 8.3 mm. A minimum lenticule thickness of 30 μm was used to ensure minimum interface interaction between the lenticule and cap cuts.

Feasibility studies conducted in Nepal using this updated lenticule profile found that the effective zone on topography was equivalent to that achieved by LASIK with a 7 mm optical zone using the ZEISS MEL 90 excimer laser.

 In the same study, it was also found that the centration achieved with hyperopia treatment with Lenticule Extraction (ZEISS SMILE) was no different to hyperopic LASIK, and the visual and refractive results were promising.

Following these studies, a prospective multicenter trial to investigate Lenticule Extraction with ZEISS SMILE for hyperopia was conducted across eight global sites from a diverse range of locations and was published in the Journal of Refractive Surgery in 2022.

 The study included 374 eyes with hyperopia up to +6.00 D and 12-month follow up using an updated nomogram based on the previous results. Overall, it was found that Lenticule Extraction for hyperopia achieved the same level of safety and efficacy as LASIK with the ZEISS MEL 90 excimer laser.

 In this study, the uncorrected distance visual acuity (UDVA) was within one line of their preoperative corrected distance visual acuity (CDVA) in 93% of patients. The refractive stability and visual outcomes were excellent, with no clinically significant loss of contrast sensitivity.

Here we describe the case of a 30-year-old male who presented for refractive surgical correction for hyperopia in both eyes. His refraction was +3.25 -1.75 x 78 (20/20) in the right eye and +3.75 -2.25 x 97 (20/20) in the left eye. He was a contact lens wearer and reported experiencing discomfort for the past eight years, for which he regularly used eye drops. The topography, tomography, and corneal thickness were all normal, and was therefore a suitable candidate for corneal laser refractive surgery. The mean keratometry was 43.89 D in the right eye and 43.91 D in the left eye, so there was ample scope for steepening. In this case, Lenticule Extraction for hyperopia was performed using the ZEISS VISUMAX 800. ZEISS SMILE pro was chosen due to the faster treatment time in addition to its minimally invasive nature and the minimization of dry eye symptoms, a key benefit for this patient.

Back to the cornea – Treating hyperopic patients with Lenticule Extraction

The treatment was planned using the standardized lenticule geometry as described above. Whereas the previous clinical trials had all been performed using the first-generation ZEISS VisuMax, the introduction of the ZEISS VISUMAX 800 includes improvements to the docking procedure including the centration assistant CentraLign

 cyclotorsion adjustment. The iris image is obtained using the ZEISS IOLMaster 700 and digitally imported into the treatment plan. During surgery, the CentraLign algorithm automatically detects the pupil and guides the surgeon to the intended treatment center. After applying suction, the system automatically calculates the cyclotorsion rotation required based on the live image of the iris.

We might expect a benefit in outcomes for cases with high astigmatism such as this patient. The other benefit of the ZEISS VISUMAX 800 is the faster cutting time, which reduces the risk of suction loss, particularly for hyperopic ZEISS SMILE pro where the overall cutting time is longer than for myopic treatments due to the larger lenticule. This aspect not only the potential of minimizing the risk of complications but also contributes to a smoother surgical experience. Due to the large optical zone required for a stable hyperopic correction, the M size contact glass is used with a cap diameter of 8.8 mm. The surgical technique is essentially the same as for myopic ZEISS SMILE or SMILE pro, except that a modified version of the Reinstein SMILE Separator should be used that has a longer 9-mm separating arm (compared to 8 mm for the similar myopic instrument).

This enables the safe separation of the interfaces across the larger cap diameter without the instrument stressing the small incision. Careful separation of the central thinnest region of the lenticule is advised. A course of mild corticosteroids for 1 month was given on completion of the standard first week post-SMILE/SMILE pro medications, in order to prevent interface haze formation.

At the day one appointment, the corneas were clear and the patient was comfortable. UDVA was 20/32 in both eyes with a spherical equivalent refraction of -0.50 D in the right eye and -0.75 D in the left eye. This slight myopic refraction would be expected to shift towards emmetropia with corneal healing and epithelial remodeling over the first 3-6 months, as observed in the previous study and after hyperopic LASIK.

 The topography showed a large and optical zone well centered on the corneal vertex (Figure 1).

The journey of hyperopic corneal treatments from near abandonment to a promising resurgence is a testament to the power of perseverance, research, and innovation in refractive surgery. This has been achieved through our understanding of optical zone and transition zone design to optimize refractive stability, centration relative to the corneal vertex rather than the entrance pupil center and the importance of epithelial mapping for evaluating risks associated with corneal steepening.

Lenticule Extraction for hyperopia with ZEISS SMILE pro presents several advantages over clear lens exchange that make it a compelling option for both surgeons and patients. With its ability to provide outcomes comparable to hyperopic LASIK with less tear film depression, ZEISS SMILE pro for hyperopia using the ZEISS VISUMAX 800 represents a promising advancement in refractive surgery, aligning with the goal of delivering high-quality care and improved patient satisfaction.

 is Medical Director of London Vision Clinic. He is also consultant to and receives travel expenses from Carl Zeiss Meditec AG, and has financial interest in ArcScan Inc.

 Reinstein DZ, Archer TJ, Gobbe M, Bartoli E. Corneal sensitivity after small-incision lenticule extraction and laser in situ keratomileusis. J C ataract Refract Surg. 2015 Aug;41(8):1580-7.

 Reinstein DZ, Pradhan KR, Carp GI, Archer TJ, Gobbe M, Sekundo W, Khan R, Citron K, Dhungana P. Small Incision Lenticule Extraction (SMILE) for Hyperopia: Optical Zone Centration. J Refract Surg. 2017 Mar 1;33(3):150-156

 Pradhan KR, Reinstein DZ, Carp GI, Archer TJ, Dhungana P. Small Incision Lenticule Extraction (SMILE) for Hyperopia: 12-Month Refractive and Visual Outcomes. J Refract Surg. 2019 Jul 1;35(7):442-450. doi: 10.3928/1081597X-20190529-01. PMID: 31298724.

 Reinstein DZ, Sekundo W, Archer TJ, Stodulka P, Ganesh S, Cochener B, Blum M, Wang Y, Zhou X. SMILE for Hyperopia With and Without Astigmatism: Results of a Prospective Multicenter 12-Month Study. J Refract Surg. 2022 Dec;38(12):760-769.

 Reinstein DZ, Carp GI, Archer TJ, Day AC, Vida RS. Outcomes for Hyperopic LASIK With the MEL 90® Excimer Laser. J Refract Surg. 2018 Dec 1;34(12):799-808.

 Reinstein DZ, Gobbe M, Archer TJ. Coaxially sighted corneal light reflex versus entrance pupil center centration of moderate to high hyperopic corneal ablations in eyes with small and large angle kappa. J Refract Surg. 2013 Aug;29(8):518-25.

 Reinstein DZ, Carp GI, Archer TJ, Buick T, Gobbe M, Rowe EL, Jukic M, Brandon E, Moore J, Moore T. LASIK for the Correction of High Hyperopic Astigmatism With Epithelial Thickness Monitoring. J Refract Surg. 2017 May 1;33(5):314-321.

Industry updates from Floretina ICOOR 2024

This article is dedicated to the memory of Ramin Tadayoni, MD, PhD.

Data from the Global Burden of Disease Study showed that in 2020, diabetic retinopathy (DR) ranked as the fifth most common cause of blindness and moderate and severe vision impairment among adults aged 50 years and older.

 Despite advances in medical/pharmacologic therapy for achieving systemic metabolic control and for managing diabetic eye disease, the burden of these consequences of DR may be expected to increase in association with population aging and as the prevalence of diabetes continues to rise.

Surgical intervention with vitrectomy is required for the management of some vision-threatening complications of proliferative DR, including tractional retinal detachment involving or threatening the fovea, persistent vitreous hemorrhage, mixed retinal detachment, and tractional diabetic macular edema. The surgical goals include relieving traction, removing fibrovascular proliferation and the posterior hyaloid, and ensuring retinal attachment with tamponade as needed. Determining the need and urgency for performing vitrectomy and achieving optimal functional and anatomical surgical outcomes depends on the ability to visualize the pathology. Developments in technologies for diagnostic imaging and surgical visualization enable clinicians to make informed decisions by visualizing pathology, and subsequently improving patient outcomes.

In addition to establishing the indication for surgery, findings on preoperative imaging are used for planning the procedure and have prognostic significance. Referral to preoperative images facilitates location of interventional targets, and there is accumulating evidence demonstrating that certain features in eyes with DR are predictors for risk of DR progression and visual outcome.

Color fundus photography (CFP) has been the mainstay for evaluating eyes with DR. However, the 7-standard ETDRS fields provide a limited field of view (75°) and fail to capture pathology existing in the peripheral retina, which has become of significant importance for predicting progression of DR.3 In addition, visualization of the fibrovascular proliferation and its extension beyond the mid-periphery is critical for planning surgery in eyes with tractional retinal detachment (Figure 1). Currently available dedicated widefield and ultra-widefield camera systems provide single capture FOVs beyond the 7-field ETDRS area offering acquisition efficiency, enhanced patient comfort, and view beyond the mid-periphery. The ZEISS CLARUS is one such UWF fundus camera with a FOV of 133° for a single image and up to 267° with ultra-wide field montage.

In addition to CFP, optical coherence tomography (OCT) is a cornerstone in the evaluation and management of diabetic eye disease. OCT provides high resolution images of retinal morphology and relevant DR lesions that makes it a valuable aid in establishing the need for medical or surgical intervention and procedure planning. The detailed OCT images can also allow detection of pathology that can be overlooked on the color fundus photographs, such as small retinal breaks or areas of fibrovascular proliferation. OCT biomarkers such as Disorganization of the Retinal Inner Layers (DRIL) are also important for determining visual prognosis and treatment response of patients with diabetic macular edema (DME).

When used together, quality images from CFP and OCT enable understanding of the extent of proliferation and the connection of the posterior hyaloid to new vessels. Surgically this is important to understand where to initiate opening in the posterior hyaloid face.

Used to assess retinal vasculature, fluorescein angiography (FA) has also been a key diagnostic tool for imaging eyes with DR, and its utility has expanded with the development of widefield and ultra-widefield technologies. Nevertheless, FA is an invasive technique that carries risks and is contraindicated in certain patients. Furthermore, FA has limited depth resolution, and obtaining good quality images depends on operator expertise.

OCT angiography (OCTA) is a noninvasive study that provides depth-resolved images of the retinal microvasculature without need for a highly trained operator. However, OCTA does not identify leakage, and so it serves as a complement to FA rather than an alternative. OCTA is especially important for visualizing changes to the foveal avascular zone (FAZ), retinal ischemia, and changes to the vascular density that are difficult to detect and quantify on FA (Figure 1). These OCTA biomarkers provide diagnostic, prognostic, and predictive information related to visual outcome, risk of progression, and response to treatment (intravitreal steroid or anti-VEGF).

Advances in intra-operative visualization

Obtaining maximal visualization intraoperatively is critical to the success of vitrectomy performed for complications of proliferative diabetic retinopathy (PDR). The utilization of a microscope-integrated intraoperative OCT (iOCT) is very crucial as it addresses this need by enhancing identification of existing pathology and allowing surgeons to operate with greater safety and precision near the retina.

Use of a heads-up three-dimensional (3D) digital viewing system, such as the ZEISS ARTEVO 800 or its successor, the ZEISS ARTEVO 850, also provides benefits when performing vitrectomy for complications of DR. The 3D digital visualization offers enhanced resolution, magnification, and depth of field, with the latter having particular value in cases where the fibrovascular proliferation is attached to the posterior pole. This technology also allows the operation to be performed with a lower light intensity that results in less glare for the surgeon and less risk of phototoxicity for the patient. Moreover, surgeons benefit from the ergonomic advantages of using a heads-up display.

The following cases involving patients with PDR illustrate how I use advanced imaging technologies to help me with diagnosis, surgical planning, and intraoperative decision-making.

A 29-year-old patient presented with significant vision loss in the left eye. On examination she was found to have 20/200 BCVA associated with tractional retinal detachment. The B scan OCT image showed vast fibrovascular proliferation along the arcade and traction on the macula. The patient was scheduled for surgery (Figure 2).

Case 1 Example

Case example 1: Surgical management of a patient with proliferative diabetic retinopathy.

iOCT was used to confirm the planned site for opening the posterior hyaloid, guided its removal from sites of attachment to the posterior pole and the midperiphery, and used to verify absence of residual hyaloid (Video 1).The intraoperative imaging also revealed new vessels attached to the fovea border that made careful dissection mandatory for optimizing functional results. With good visualization, I was able to complete the dissection without causing any intraoperative breaks and therefore avoid the need for tamponade.

A second case also involved a relatively young patient with type 1 diabetes found to have proliferation of new vessels primarily on the optic nerve head but also along the major vascular arcades. Earlier intravitreal injection of an anti-VEGF agent increased traction on the retina. Therefore, it was crucial to find the space between the retina and the proliferation for opening the posterior hyaloid and to remove the proliferation without inducing traction while minimizing the risk for causing a break. Using iOCT after completing the dissection of the new vessels allowed me to check the status of the macula and confirm absence of a break (Figure 3).


Quality pre-operative imaging is essential for determining the surgical indication and treatment plan in eyes with PDR. Precise analysis of the extension of the fibrovascular proliferations and of the attachment to the posterior hyaloid serves as a guide to surgical decision-making. In the same way, iOCT associated with a high-resolution digital microscope has a valuable role in the effectiveness and safety of these delicate surgeries where accurate identification of dissection planes and the absence of iatrogenic dehiscence is crucial for achieving success.

GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. 

Teo ZL, Tham YC, Yu M, et al. Global prevalence of diabetic retinopathy and projection of burden through 2045: Systematic review and meta-analysis. 

Silva PS, Cavallerano JD, Haddad NMN, et al. Peripheral lesions identified on ultrawide field imaging predict increased risk of diabetic retinopathy progression over 4 years. 

Joltikov KA, Sesi CA, de Castro VM, et al. 

Munk MR, Somfai GM, de Smet MD, et al. The role of intravitreal corticosteroids in the treatment of DME: Predictive OCT biomarkers. 

Vujosevic S, Cunha-Vaz J, Figueira, J, et al. Standardization of optical coherence tomography angiography imaging biomarkers in diabetic retinal disease. 

Prof. Aude Couturier is an ophthalmologist at hospital Lariboisière (AP-HP) in Paris. She is specialized in vitreoretinal surgery, treatment of retinal diseases and retinal imaging.

Optimizing diagnosis and surgical management of diabetic retinopathy using advanced imaging technologies 

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.

To Infinity and (PRES)BYOND - The game changer for my practice

Good vision at near and intermediate distances is important in today’s world where so much time is spent using smartphones and computers. For patients who are interested in achieving spectacle independence after cataract surgery, IOL manufacturers have sought to address this need by introducing a variety of presbyopia-correcting IOLs based on different optical designs to provide an extended range of vision. The hydrophobic acrylic ZEISS AT ELANA 841P, a new trifocal fully preloaded IOL (Carl Zeiss Meditec, AG; Jena, Germany), became one of the latest entries into the category of presbyopia-correcting IOLs.

The AT ELANA 841P combines leading technologies when it comes to optical performance, biomaterial properties, and IOL design. Namely, the AT ELANA 841P optic design is based on that of the trifocal AT LISA

 tri 839MP. There is abundant clinical proof that the AT LISA tri delivers good uncorrected vision for near and intermediate without compromising distance visual acuity.

 Distinguishing itself from the AT LISA tri, the AT ELANA optic was modified to have increased light transmission efficiency and a higher allocation of light towards near vision to enhance near-to-intermediate vision without compromising far vision.* In addition, AT ELANA 841P features a spherical aberration neutral design and stays fully trifocal regardless of pupil size.

The biomaterial and platform design of the AT ELANA 841P are features shared with the monofocal ZEISS CT LUCIA 621P IOL. The AT ELANA 841P is made of a glistening-free** hydrophobic acrylic biomaterial with a heparin-coated*** surface to ensure optical clarity and smooth and controlled unfolding of the IOL.

I took notice of the AT ELANA 841P because it has features that I prioritize when choosing a presbyopia-correcting implant for my cataract surgery patients. Specifically, if the patient meets certain parameters, I prefer diffractive trifocal technology because I believe it gives patients the best chance of obtaining good quality vision at near, intermediate, and distance. In addition, I favor hydrophobic lenses because the development of posterior capsule opacification (PCO) tends to be slower, and anterior capsule contraction has also been shown to be lower with the hydrophobic material.

 Further reducing the chance of PCO, the AT ELANA 841P optic has a 360° sharp edge design. I also appreciated that the AT ELANA’s biomaterial reduces the risk of glistening and that the IOL comes fully preloaded in the easy-to-use BLUESERT™ injector; preloading minimizes the risk of IOL damage and increases surgical efficiency and safety. Finally, the AT ELANA 841P is available in a wide dioptric range (0.0 to +34.0 D).

Still, it is my practice to proceed cautiously when trying any new IOL, even more so with premium IOL technologies. I begin by reviewing findings from bench testing to see if the results for modulation transfer function, light distribution for different foci, and point spread function support claims about range of vision, vision quality, and visual symptoms. If the laboratory evidence is convincing, I begin using the new lens in a limited number of patients who have the characteristics that I consider ideal for the IOL based on its optical bench performance. Trialing the lens in this way allows me to see if the achieved results match my expectations. I also like to review my early refractive outcomes to determine the need for lens constant optimization.

Patient selection criteria and early outcomes

 test results for the AT ELANA 841P showing it had good optical performance across an extended range of distances that was at least comparable to the AT LISA tri and slightly better at near to intermediate distances.

 The patients I considered as candidates for my initial use of the AT ELANA 841P were identified by their interest in achieving true spectacle independence after cataract surgery. All patients received thorough preoperative counseling to explain potential pros and cons and set realistic expectations. I usually do not implant a multifocal IOL in any patient whose occupation involves night driving because the potential for halos and glare is a limitation associated with all multifocal technology.

 I also do not offer multifocal IOLs to any patient with severe dry eye because a stable tear film and healthy ocular surface are essential for achieving good quality vision with multifocal technology.

Because the AT ELANA 841P is not yet available in a toric version and taking into account my surgically-induced astigmatism, I excluded patients with astigmatism >1.50 D with-the-rule or >1.0 D against-the-rule. Considering that the AT ELANA 841P has an overall diameter of 13.0 mm and due to concern about the potential for decentration when implanting a lens with a diameter that exceeds the white-to-white (WTW) measurement, I also excluded patients with a WTW >12.5 mm. For the latter patients, I have an option for implanting a ZEISS trifocal IOL using the AT LISA tri instead.

I planned the AT ELANA 841P surgeries using the IOLMaster

 700 (Carl Zeiss Meditec, AG; Jena, Germany) for biometry and the ESCRS Calculator using the Kane formula for IOL power calculation with a target refraction of emmetropia. Surgery was performed through a 2.2 mm incision at the steepest meridian, and the AT ELANA 841P was delivered with a docking technique through the same incision. As exceptions to this approach, I operate through a 2.4 mm limbal incision in cases where the IOL power is >25-26 D.

Preoperatively, mean sphere for the six eyes of the first three patients I implanted was 1.10 D ± 2.12 D and mean cylinder -0.21 D ± 0.32 D. All patients returned for follow-up after 1 week, 1 month, and 3 months. Slit-lamp examination showed that all AT ELANA 841P IOLs were stable and well centered. Mean sphere was 0.033 D ± 0.25 D, and mean cylinder was -0.00 D ± 0.22D. Visual acuity (in decimal) results were excellent. Mean monocular UCVA was 0.96 ± 0.08, mean binocular UCVA was 1.0 ± 0, mean monocular DCVA was 1.0 ± 0, and mean binocular DCVA was 1.2 ± 0.

Patients were very happy with their outcomes and reported not needing glasses for daily activities despite being left slightly hyperopic, which suggests the AT ELANA 841P may be tolerant to minor refractive error. As shown by the binocular defocus curve for one patient, bilateral implantation of AT ELANA 841P IOLs provided a full range of good vision with VA (in decimal) of 1.0 at distance, 0.8 at intermediate (66 cm), 1.0 at near (40 cm) (Figure 2).

Two patients admitted to seeing halos when asked directly about specific visual symptoms, but no patient complained spontaneously about photic phenomena or said they were bothered by halos or glare.

With its diffractive trifocal optic and hydrophobic acrylic material, the AT ELANA 841P matches two of my preferences for choosing a presbyopia-correcting IOL. Importantly, I found that in my early surgical experience, bilateral implantation of this new trifocal lens resulted in very satisfied patients who were happy with their ability to see well without correction at near, intermediate, and distance.

I will continue to review my outcomes with the AT ELANA 841P as my experience with it increases, and I expect I might even see some improvement because I optimized my lens constant. Currently, I feel comfortable both expanding use of the AT ELANA 841P in my practice and encouraging other surgeons to consider it.

* Compared to AT LISA tri in photopic conditions in virtual implantations and optical bench tests.

** Grade 1 (traces) or better for 85% of the patients up to and including 12 months according to Christiansen scale and based on internal clinical trial outcomes and on published clinical data.

*** Fragment of heparin used in IOL surface coating with no pharmacological, immunological or metabolic action.

Mojžiš P, Majerova K, Plaza-Puche AB, Hrckova L, Alio JL. Visual outcomes of a new toric trifocal diffractive intraocular lens. 

Mojžiš P, Kukuckova L, Majerova K, Ziak P, Piñero DP. Postoperative visual performance with a bifocal and trifocal diffractive intraocular lens during a 1-year follow-up. 

Zhao Y, Yang K, Li J, Huang Y, Zhu S. Comparison of hydrophobic and hydrophilic intraocular lens in preventing posterior capsule opacification after cataract surgery: An updated meta-analysis. 

Chen L, Zhong Y, Yao K, Fu Q. Effect of intraocular lens material and haptic design on anterior capsule contraction after cataract surgery: A systematic review and meta-analysis. 

Laxmi V. Devisetty, MD; and Thiran Jayasundera, MD, MS, FACS, FRCSC, FANZCO

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