How surgeons across Europe are dealing with the challenges faced by

The future of laser vision correction

Cheryl Guttman Krader and Dermot McGrath report on how surgeons across Europe are dealing with the challenges of COVID-19

When the COVID-19 lockdown restrictions were initially eased and Germany began to reopen in the middle of May, the country had one of the lowest death rates from the novel coronavirus in the world.

By the time June was ending, Michael C Knorz MD, Professor of Ophthalmology, FreeVis LASIK Center at the University Eye Clinic, Mannheim, Germany, said that he had essentially taken care of the backlog of cases of laser vision correction (LVC) that had been deferred during the shutdown. In addition, new inquiries from patients interested in a refractive procedure seemed to have dropped minimally relative to pre-pandemic days. When asked about his thoughts regarding how COVID-19 would impact the future of LVC, however, Dr Knorz

offered a dichotomous perspective.

He told EuroTimes: “I am an optimistic person, and I do not believe that COVID19 by itself will have a significant impact on laser refractive surgery. We could live with it, just like we live with the flu.”

Yet, Dr Knorz qualified his comment by noting it represents a rational view. His response based on an emotional reaction is more pessimistic.

“From what I see, the whole world is in a panic mode today and seems to be grossly overreacting to the scientific facts. This extreme overreaction will cause an economic downturn that will affect laser refractive surgery in the same negative way it will affect other aspects of our lives, and it may lead to a global depression,” Dr Knorz said.

“I truly hope that politicians will come to their senses, but we will have to wait and see the course ahead. A reliable prediction of the future of laser refractive surgery is not possible today. In the coming months we will see what happens.”

PRACTICE UPDATE Dr Knorz reopened his practice to elective surgery April 20. Patients were contacted to reschedule the LVC procedures that were cancelled because of the lockdown, and only a few decided they would not go forward.

“By the end of June, over 90% of the patients whose LVC procedure was deferred had undergone their surgery,” Dr Knorz said.

Interest in LVC remains. Relative to the months preceding the pandemic, Dr Knorz said he has seen a drop of only 5-to-10% in the number of inquiries for consultation visits.

Dr Knorz believes that unemployment, with its accompanying loss of income, will be the primary factor determining uptake of LVC going forward.

“In Germany, we are quite lucky because unemployment is not a big issue yet. Job loss, however, was the main reason given by the approximately 10% of our patients who decided not to go ahead with their planned surgery when we called them back to reschedule it,” he said.

Dr Knorz said that so far, he has not seen any age-related difference in patient willingness to proceed with the elective procedure.

“Both our lens patients in the 50-to-70- year age range who are candidates for refractive lens exchange and our LVC

patients are mostly willing to come for surgery,” he observed.

COVID-19 has necessitated new processes to ensure a safe environment, and making patients aware of the strategies being implemented is critical to their willingness to attend office visits and proceed with surgery. At the FreeVis LASIK Center, all patients are given a surgical mask and sanitising gel to disinfect their hands at entry, and no more than six patients are allowed in the 20m-squared waiting room. Disinfection of all contacted surfaces and instruments is being done in view of patients, and all documents are now being handled electronically with Adobe Sign used for informed consent and invoices.

“The feedback we have received from patients is that they feel very safe,” said Dr Knorz.

AGGRESSIVE RESPONSE Thanks to a swift, aggressive government response to early cases of COVID-19, Greece was one of the first countries to see restrictions eased.

Despite the absence of a mandate, A John Kanellopoulos MD, Director, Laservision Eye Institute, Athens, Greece, chose from March 1 to voluntarily stop performing all elective surgeries at his centre and enforce spacing between patient exams along with wearing of facial masks and gloves for all. By mid-May, just a few weeks after the beginning of staged lifting of COVID-19 restrictions, he was already seeing patients for laser vision correction (LVC) consultation visits and

I truly hope that politicians will come to their senses, but we will have to wait and see the course ahead. A reliable prediction of the future of laser refractive surgery is not possible today Michael C Knorz MD

A patient undergoing laser vision correction surgery

performing his first operations.

Considering the level of patient interest and the value of laser refractive surgery, Dr Kanellopoulos is hopeful about its future.

“If we do not let our guard down and remain dedicated to delivering safe and ethical care, I believe the volume of LVC will return to the pre-pandemic state,” he told EuroTimes.

Dr Kanellopoulos recalled that during the lockdown period in Greece, he was contacted by several patients who were interested in Laser Vision Correction surgery because they felt the “down time” they had from work and other usual activities offered an opportune time to undergo the surgery.

He also postulated that the stay-athome situation itself, may have fuelled interest in LVC.

“With more unoccupied time, some individuals may have focused more on difficulties they were having with contact lenses and/or self-reflected on making lifestyle changes,” Dr Kanellopoulos explained.

“With safety in mind, we kindly deferred and postponed requests to perform surgery during the lockdown; parallel to this we counselled patients to try to refrain from wearing contact lenses considering that they may become a mode of transmission for the coronavirus.”

Although in general, people in Greece are still somehow limiting some of their elective and leisure activities, including choosing to undergo various elective surgeries, Dr Kanellopoulos said that he is seeing an increased interest in LVC relative to the past.

“Although my surgical volume has not returned to what it was a year ago at this same time, the proportion of my surgical population that is interested in LVC has grown,” he said.

“Previously, laser refractive surgery accounted for approximately one-third of my surgical practice. Now almost half of the patients I see are interested in updating their contact lens prescription and very interested in LVC.

Dr Kanellopoulos suggested the

“surge” may have been enhanced by his having incorporated ray-tracing customisation and excellent early results We recognise, however, that in making since November 2019 using an artificial the decision to undergo surgery and intelligence platform that combines wavefront, Scheimpflug tomography and for support postoperatively, many interferometry measurements from a single device. Implementation of measures to patients rely on an informed family member or friend minimise risk for virus transmission is John Kanellopoulos MD critical so that patients are comfortable coming in for a consultation visit and proceeding with surgery. The changes include wearing of surgical face masks appointment types except for contact an online COVID-19 form that we send at all times-by all staff, breath shields on lens trial appointments. We had virtual them prior to their appointment where all slit-lamps, and reconfiguration of the consultations and the odd in-person they state the same and digitally sign waiting area to maintain social distancing consultation for emergencies during before submitting. among others. lockdown,” said Arthur B. Cummings All diagnostic equipment and rooms are

Prior to their visit, patients are carefully FRCSEd, Medical Director deep cleaned each morning as standard prescreened for infection or recent exposure Liz Brennan, Head of Research and COVID and alcohol wipes used between to COVID-19. At entry into the building, Clinical Support at the clinic says they have patients. Since reopening, staff at the clinic they are given disposable masks and gloves removed many of the chairs in the waiting have increased the frequency of this deep to wear and must clean their shoes with area, added screens to separate patients clean throughout the day, ensuring to a disinfectant solution. In addition, adult where chairs are closer, asked all patients to include phones, keyboards, light switches, patients must be unaccompanied unless wear masks and put phones in zip lock bags door handles and chair they require assistance for ambulation or and sanitised station set up at the entrance armrests as well as the device another issue. with a motion sensor “welcome doorbell” and equipment tables.

“We recognise, however, that in that notifies the team that someone has making the decision to undergo surgery arrived at the sanitising station. and for support postoperatively, many patients rely on an informed family “The team wash hands between every patient (as per usual) and the clinical team If we do not let our member or friend. Therefore, we have employed extraordinary measures using videoconferencing and live, private online are wearing gloves for clinical exams. All patients attend the assessment station in the hospital assessment area prior to guard down and remain dedicated to broadcasting of each surgery to fulfil this need,” Dr Kanellopoulos said. their appointment in our clinic and all staff have their temperature checked twice delivering safe and

“Our team’s high standards and my daily. This is logged on a tracker that also ethical care, I believe personal quest in offering excellence in patient care has been the driving force allows us to monitor staff contacts in the event of a requirement to contact trace,” the volume of LVC in rebooting refractive surgery in our practice post COVID-19. I personally have found the great majority of patients she said. They have also added a large splash screen at the front desk and smaller will return to the prepandemic state to have ‘returned’ to normalcy with a more screens and breath shields at devices John Kanellopoulos MD heartfelt physician-patient relationship, and slit lamps. Floor stickers also give a and I am thrilled!” visual guide to patients and patients are instructed to conduct conversations in Dr Cummings says that the lessons SCREENING IS IMPORTANT the consultation room once the medical learned from dealing with the COVID-19 When Ireland started to ease its lockdown measures, ophthalmologists faced the challenge of getting their practices back up and running to deal with patient demand. The Wellington Eye Clinic in Dublin, one of the country’s best-known cataract and refractive surgery practices, introduced a range of measures to reassure patients and minimise disruption in the wake of the COVID-19 pandemic. “We have resumed the majority of staff is at the sticker (i.e. 2m away) Screening is also important, said Dr Cummings. All patients visit an assessment station in the concourse where they are asked a series of questions to check potential exposure/ symptoms and they have their temperature checked. They are given a clearance certificate which they present to us on arrival at reception and this is scanned into their EMR file. They also complete and submit pandemic will have long-term benefits. “It has been a period of adjustment for us as a team. All of our processes have been challenged with COVID but our team came together via Zoom staff meetings to offer their feedback and ideas of how our new process and patient journey would work. Collectively, we designed a new process that aimed to have maximum safety and convenience for the patient while keeping our team safe too. We have introduced online medical history forms and payment links and we We have resumed the majority of are currently reviewing options to allow patients to book their appointments via appointment types except for contact an automated SMS system. “While we are not at the stage yet, I lens trial appointments. We had virtual consultations and the odd inthink in time that we will look back on this time as a major challenge for the clinic but one that forced growth that may person consultation for emergencies not have occurred without COVID and which will leave us with a more efficient during lockdown clinic as a result,” he said. Arthur B. Cummings FRCSEd

Check Diana OCT results. OCT results.

OZURDEX ® has multiple modes of action, 1 –3 a low treatment burden 4 –7 and a manageable safety profi le. 6–8

TRY DIFFERENT LETTERS IN YOUR PRESCRIPTION FOR DME

DME, diabetic macular edema; OCT, optical coherence tomography. 1. Nehmé A and Edelman J. Invest Ophthalmol Vis Sci 2008;49(5):2030–2038. 2. Holekamp N. The role of corticosteroid implants in DME. Available at: http://retinatoday.com/2015/04/the-role-of-corticosteroid-implants-in-dme. Accessed March 2020. 3. Campochiario PA et al. Am J Ophthalmol 2016;168:13–23. 4. Malclès A et al. Retina 2017;37(4):753–760. 5. Matonti F et al. Eur J Ophthamol 2016;26(5):454–459. 6. Aknin I and Melki L. Ophthalmolgica 2016;235:187–188. 7. Allergan. OZURDEX ® . Summary of Product Characteristics. October 2019. 8. Boyer SB et al. Ophthalmology 2014;121(10):1904–1914.

OZURDEX® (Dexamethasone 700 micrograms intravitreal implant in applicator) Abbreviated Prescribing Information

Presentation: Intravitreal implant in applicator. One implant contains 700 micrograms of dexamethasone. Disposable injection device, containing a rod-shaped implant which is not visible. The implant is approximately 0.46 mm in diameter and 6 mm in length. Indications: Treatment of adult patients: with macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO), in ammation of the posterior segment of the eye presenting as non-infectious uveitis and visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are considered insu ciently responsive to, or unsuitable for non-corticosteroid therapy. Dosage and Administration: Please refer to the Summary of Product Characteristics before prescribing for full information. OZURDEX must be administered by a quali ed ophthalmologist experienced in intravitreal injections. The recommended dose is one OZURDEX implant to be administered intra-vitreally to the a ected eye. Administration to both eyes concurrently is not recommended. Repeat doses should be considered when a patient experiences a response to treatment followed subsequently by a loss in visual acuity and in the physician’s opinion may bene t from retreatment without being exposed to signi cant risk. Patients who experience and retain improved vision should not be retreated. Patients who experience a deterioration in vision, which is not slowed by OZURDEX, should not be retreated. In RVO and uveitis there is only very limited information on repeat dosing intervals less than 6 months. There is currently no experience of repeat administrations in posterior segment non-infectious uveitis or beyond 2 implants in Retinal Vein Occlusion. In DME there is no experience of repeat administration beyond 7 implants. Patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs. Single-use intravitreal implant in applicator for intravitreal use only. The intravitreal injection procedure should be carried out under controlled aseptic conditions as described in the Summary of Product Characteristics. The patient should be instructed to self-administer broad spectrum antimicrobial drops daily for 3 days before and after each injection. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. Advanced glaucoma which cannot be adequately controlled by medicinal products alone. Aphakic eyes with ruptured posterior lens capsule. Eyes with Anterior Chamber Intraocular Lens (ACIOL), iris or transscleral  xated intraocular lens and ruptured posterior lens capsule.

Warnings/Precautions: Intravitreous injections, including OZURDEX can be associated with endophthalmitis, intraocular in ammation, increased intraocular pressure and retinal detachment. Proper aseptic injection techniques must always be used. Patients should be monitored following the injection to permit early treatment if an infection or increased intraocular pressure occurs. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients must be instructed to report any symptoms suggestive of endophthalmitis or any of the above mentioned events without delay. All patients with posterior capsule tear, such as those with a posterior lens (e.g. due to cataract surgery), and/or those who have an iris opening to the vitreous cavity (e.g. due to iridectomy) with or without a history of vitrectomy, are at risk of implant migration into the anterior chamber. Implant migration to the anterior chamber may lead to corneal oedema. Persistent severe corneal oedema could progress to the need for corneal transplantation. Other than those patients contraindicated where OZURDEX should not be used, OZURDEX should be used with caution and only following a careful risk bene t assessment. These patients should be closely monitored to allow for early diagnosis and management of device migration. Use of corticosteroids, including OZURDEX, may induce cataracts (including posterior subcapsular cataracts), increased IOP, steroid induced glaucoma and may result in secondary ocular infections. The rise in IOP is normally manageable with IOP lowering medication. Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex and not be used in active ocular herpes simplex. OZURDEX is not recommended in patients with macular oedema secondary to RVO with signi cant retinal ischemia. OZURDEX should be used with caution in patients taking anti-coagulant or anti-platelet medicinal products. OZURDEX administration to both eyes concurrently is not recommended. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, consider evaluating for possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Interactions: No interaction studies have been performed. Systemic absorption is minimal and no interactions are anticipated. Pregnancy: There are no adequate data from the use of intravitreally administered dexamethasone in pregnant women. OZURDEX is not recommended during pregnancy unless the potential bene t justi es the potential risk to the foetus. Lactation: Dexamethasone is excreted in breast milk. No e ects on the child are anticipated due to the route of administration and the resulting systemic levels. However OZURDEX is not recommended during breast-feeding unless clearly necessary. Driving/Use of Machines: Patients may experience temporarily reduced vision after receiving OZURDEX by intravitreal injection. They should not drive or use machines until this has resolved. Adverse E ects: In clinical trials the most frequently reported adverse events were increased intraocular pressure (IOP), cataract and conjunctival haemorrhage*. Increased IOP with OZURDEX peaked at day 60 and returned to baseline levels by day 180. The majority of elevations of IOP either did not require treatment or were managed with the temporary use of topical IOP-lowering medicinal products. 1% of patients (4/347 in DME and 3/421 in RVO) had surgical procedures in the study eye for the treatment of IOP elevation. The following adverse events were reported: Very Common (≥ 1/10): IOP increased, cataract, conjunctival haemorrhage*. Common (≥1/100 to <1/10): headache, ocular hypertension, cataract subcapsular, vitreous haemorrhage*, visual acuity reduced*, visual impairment/disturbance, vitreous detachment*, vitreous floaters*, vitreous opacities*, blepharitis, eye pain*, photopsia*, conjunctival oedema*, conjunctival hyperaemia. Uncommon (≥1/1,000 to <1/100): migraine, necrotizing retinitis, endophthalmitis*, glaucoma, retinal detachment*, retinal tear*, hypotony of the eye*, anterior chamber in ammation*, anterior chamber cells/ ares*, abnormal sensation in eye*, eyelids pruritus, scleral hyperaemia*, device dislocation* (migration of implant) with or without corneal oedema , complication of device insertion resulting in ocular tissue injury* (implant misplacement). (*Adverse reactions considered to be related to the intravitreous injection procedure rather than the dexamethasone implant). Please refer to Summary of Product Characteristics for full information on side e ects. Basic NHS Price: £870 (ex VAT) per pack containing 1 implant. Marketing Authorisation Number: EU/1/10/638/001. Marketing Authorisation Holder: Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, Co. Mayo, Ireland. Legal Category: POM. Date of Preparation: May 2019. UK/0288/2019

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ Adverse events should also be reported to Allergan Ltd. UK_Medinfo@allergan.com or 01628 494026

License and adverse events reporting may vary by country, please consult your local Summary of Product Characteristics. Date of preparation: March 2020 INT-OZU-2050057