The new normal in

Refractive surgery now

EUROCOVCAT is a group of cataract and refractive surgeons which has met on Zoom several times to discuss how to get back to practising ophthalmology in the most safe, efficient manner in the months and years ahead. This article, the second of two articles written exclusively for EuroTimes, provides an insight on how to rethink cataract care

Garcia-Gonzalez Montserrat, University of Alcalá, Rementería clinic, Madrid, Spain, Gros-Otero Juan, CEU San Pablo University, Rementería clinic, Madrid, Spain; Aslan Bekir S, Ankara Memorial Hospital, Ankara, Turkey; Carones Francesco, Carones Vision, Milan, Italy; Cummings Arthur B, Wellington Eye Clinic, Dublin, Ireland; Darcy Kieren, Bristol Eye Hospital, UK; Gundersen Kjell-Gunnar, Ifocus Øyeklinikk, Haugesund, Norway; Malyugin, Boris S. Fyodorov Eye Microsurgery Federal State Institution, Moscow, Russian Federation; Mrochen Michael, IROC Science to Innovation, Zurich, Switzerland; Murta Joaquim, Coimbra University, Portugal; Teus Miguel-Angel, University of Alcalá, Madrid, Spain.

WHAT NEEDS TO BE CONSIDERED? Our recommendations should be used in accordance with local guidance from health authorities and national ophthalmic societies.

1. Close monitoring for staff:

a.Daily temperature measurement in addition to self-monitoring symptom questionnaires b.Strict hand hygiene c. Wearing masks, as it is not possible to maintain the two metres of social distance suggested by WHO d.Once in the operating room, standard rules for sterile surgery may apply: wearing surgical gown, masks, gloves and hair cap. Refractive surgery is performed through a surgical microscope, making use of a face shield or goggles more difficult. Manoeuvres oriented to decrease aerosols during surgery are encouraged e.g. the use of HPMC and smaller incision sizes during phacoemulsification. e. Staff shift patterns need to be determine locally, depending on the size of the workforce of each clinic/hospital.

2. Social distancing, patient safety and

consent: The number of patients per hour will vary dependent upon the capacity of the waiting room, the number of staff working simultaneously and the physical flow of the clinic. Increasing opening hours can help compensate, but it is essential this is balanced against the additional cost and welfare of the staff. Our patients’ safety must be prioritised. Regulatory requirements vary around the world, but an effective informed consent process should remain a central tenet of best practice. It may be in the patients’ best interest to perform the initial consultation virtually to minimise any unnecessary visits. Throughout the process, a clear line of dialogue should exist between the patient and operating surgeon.

3. Correct patient engagement

and communication flow: Sending patient videos detailing what to expect before the visit and the sequence of the day is likely to improve the efficiency and flow whilst in clinic. Educating them of the PPE and social distancing protocols being followed in the clinic will also provide additional reassurance. Videos describing the procedures that are potentially suitable enables a more concise and succinct discussion, whilst simultaneously improving the consent process. It may also be helpful to address additional issues such as the possibility of any existing dry eye so that lubricants could be started even before the first visit. This reduces both the risk of deferring surgery and any additional face-to-face consultations required for reassessment after a period of dry eye treatment. Use social media to show the safety guidelines to which the clinic adheres 4. Clinic and staff resources: Each clinic will have differing capacity constraints Addressing this will need a localised approach, but some suggestions are: a.Extend opening hours b.Increase clinical space or the number of offices c. Hire new consultants d.Stagger patient visits

5. Virtual consultation/telemedicine:

We recommend different approaches for the preoperative and postoperative visits: a. Preoperative: Virtual consultations can be utilised to perform an initial consultation where targets are being discussed and goals set. Face-to-face consultations should be reserved for scans, performing a physical exam and debriefing only. Try to determine which scans are required during the virtual consultation to improve flow and efficiency during the face-to-face consultation, but examinations may need to be extended if unexpected findings appear during the visit. A number of clues can be used to assist this, such as age, refractive error, the presence of presbyopia, etc. If the post-examination discussion is protracted, complete this virtually, even whilst in the clinic setting. The doctor and patient should be in different rooms with the use of video technology. b. Postoperative: This will need tailoring to the procedure undertaken. We recommend avoiding telemedicine for early follow-up visits (24 hours and first week visit) after LASIK or RELEX procedures, as severe sight-threatening complications could be missed, but for other follow ups (first month or three-month post-op visits), this might be a very valuable option. In contrast, following surface ablation, the 24-hour visit may be substituted for a phone call, but it then becomes mandatory to review these patients around five-toseven days post-op to check the epithelial integrity and remove the bandage contact lens. Postoperatively, virtual consultations can be very helpful. Although direct examination is not possible, the patient can be assessed for comfort, their postoperative course and overall satisfaction. An increasing number of apps can be used to assess gross visual acuity testing, contrast sensitivity and even including quantitative measures of visual function and ease of vision.

Patients need to be reassured of the safety measures put into place in each clinic or hospital. This is especially important for elective surgery. Patients have expressed concerns how postoperative care will be undertaken in case of another lockdown. Reassurance should be offered detailing how care will continue with robust plans. Additionally, improving our professional network is useful as we might need assistance from colleagues in other cities/countries to continue our follow up if new lock downs are needed.

HOW WILL THE SURGICAL PATHWAY NEED TO CHANGE TO BEST PROTECT PATIENTS AND STAFF?

Pre-Surgical: Patient Assessment

Ophthalmologists must be considered a high-risk category because of their close contact with patients. Effective hygiene routines and personal protective equipment reduce this risk. However, in addition to close person-to-person respiratory droplet spread, there are two further potential risks points of transmission: direct contact with the conjunctiva and tear secretions, and aerosol created during certain procedures.

We recommend the following adaptations prior to surgery:

1. The first assessment should be done by telephone one-to-three days prior to the visit: checklist questionnaire to assess if the patient has any suspicious symptoms or recent contact with a COVID-19 positive person (in these cases, the visit will be postponed). 2. In countries where period of selfisolation is stipulated prior to surgery, this should be respected. 3.In countries where COVID-19 contact tracing is active, we should encourage our patients to engage with those platforms. Early detection of infection in the postoperative period is of great value to be aware of local complications and avoid further disease spread in our offices. 4.Collect patient information remotely and electronically. Before the appointment, send an interactive electronic history form that includes all the questions that we usually ask in the clinic (age, profession, hobbies / sports, allergies, intolerance to contact lenses, symptoms of dry eye, ocular or systemic diseases, visual expectations…) 5. The patient should preferably come alone to the clinic. The use of mask is mandatory in both the waiting and examination rooms. 6. The same checklist questionnaire must be answered by the patient at the front door of the clinic, prior to entry. A temperature check can be a good screening method, but the absence of fever does not discard an asymptomatic COVID+ patient. 7. Remove magazines, coffee, water and toys from waiting rooms. Chairs should be removed or blocked with signs to maintain a social distance of one to two metres among patients. 8. Do only the mandatory in-clinic exams (i.e. manifest and cycloplegic refractions, corneal topography or tomography, anterior segment OCT, biometry, etc.) depending on the preoperative refraction and the surgical refractive procedure considered. We believe that candidates for corneal refractive surgery must receive a cycloplegic refraction, especially hyperopic patients (to evaluate the grade of latent hyperopia) and pre-presbyopic myopic patients (to avoid the risk of overcorrection of the refractive myopic defect). In addition, a dilated fundus exam is recommended preoperatively in all patients, or as a minimum in patients with a high risk of retinal detachment. 9. Limit communication with the patient during the ocular examination because talking can potentially aerosolise the virus. 10. After each patient, clean with the appropriate disinfecting products, surfaces touched by the patient, the optometrist and/or the ophthalmologist. 11. Informed consent process: the written informed consent should be given to the patients to read and sign it at home prior to surgery. This should be confirmed by the surgeon on the day of surgery. In the instance that the final treatment decision is taken on the day, patients should have received all the necessary information prior to the appointment. Any protracted discussions should be held virtually within the clinic. 12. The informed consent needs to clearly articulate that COVID-19 infection risk cannot be quantified, and that it will never be zero. 13. A clear line of communication should be maintained between the patient and operating surgeon. Any additional questions about the surgical procedure or the informed consent should be performed by video, phone or email.

The question of COVID-19 testing remains under local healthcare guidance. Some countries require PCR testing and a period of self-isolation of all surgical patients before entering the operating room, some even requiring lung x-rays to combat the specific concerns of the COVID-19 tests, while others are relying on questionnaire and temperature check, then treating all patients as if they were positive. Indeed, there are current government obligations in some markets for intense sterilisation, so there is need for more time between patients, reducing the numbers of surgeries per day so the patient management flow and pre-assessments play an important role in the process.

Surgical process and standards:

An effective risk assessment of refractive surgical procedures can help to mitigate the risk of transmission to health care professionals and patients. Our recommendations: 1. Reduce the operating schedule to be able to clean and disinfect the operating room, as well as to provide social distance in the waiting rooms. 2. Only patients are allowed into the clinic; non-essential caretakers are asked to wait outside or even in their vehicles, and they are called when the patient is being discharged. 3. Reduce the number of people in the operating room (i.e. one surgeon, one nurse, one assistant and one optometrist). 4. All staff are required to wear surgical masks and gloves, and even face shields or goggles if an aerosol-generating procedure is performed. They should be trained about wearing and removing the personal protection equipment. 5. To sterilise the eye prior to surgery, some surgeons will continue, others will start to use diluted betadine as in cataract surgery, as it is well accepted as a potent disinfectant when applied before surgery. Topical povidone iodine drops prior to corneal refractive surgery for a contact period of two minutes can reduce the effectivity of the SARS-CoV-2 virus below detectable levels. 6. Bigger drapes can be used for added precaution.

COVID-19 has brought several new considerations, to determine the best surgical technique:

a. Excimer laser light is in the ultraviolet range, which is effective in killing any viruses within the treatment zone that may be present on the cornea. b. A mechanical microkeratome involves a blade oscillating at very high frequency over the corneal surface. Aerosol is only generated if the energy source is enough to overcome particle adhesion and in the presence of an airflow to entrain particles. It has been hypothesised a mechanical microkeratome may achieve this. The use of these devices has significantly reduced since the introduction of femtosecond lasers. However, in the absence of further evidence it may be advisable to consider mechanical LASIK as a potential aerosol-generating procedure and follow the appropriate recommendations. c. In contrast, a femtosecond laser does not have any vibrating pieces in contact with the cornea and so can be considered a non-aerosolgenerating device.

There are still more questions than answers. To date SARS-CoV-2 has not been found inside the eye. Although SARS-CoV-2 has been detected on the ocular surface, it is still unclear whether the recorded presence is due to active viral replication or indirect inoculation. When detected, its presence appears better correlated with severe, symptomatic disease. This risk is mitigated by the described screening protocols and the use of betadine pre-operatively. The risk of AGP transmission in refractive surgery is therefore very low, which maintains the focus on the usual physical distancing and reduction of respiratory transmission routes. If using mechanical microkeratome for LASIK (AGP), the use of protective shields between the surgical area and the refractive surgeon are recommended, to minimise any potential risk of viral transmission.

CONCLUSION There are no “golden rules” about how refractive surgery should be restarted in Europe. Our patients need to be reassured of the safety measurements implemented in each clinic or hospital, and this is of much greater importance from the perspective of refractive surgery, as it is elective. These guidelines are recommended to reduce the risk of COVID-19 transmission, while offering the level of care that our refractive patients demand.