COVID-19 has had a significant impact on the entire global community. As we look to the future to advance the provision of eyecare excellence, opportunities for innovation must be embraced and new, patient-centric ways of managing clinical practices adopted.
Government restrictions in response to COVID-19 have forced many organisations to adopt a virtual approach alongside remote working practices. At the onset of the outbreak in Europe, we had to act quickly to adapt the way we were running clinics. High-risk patients with urgent conditions such as retinal detachment and age-related macular degeneration (AMD) had to be prioritised, given the importance of immediate diagnosis and treatment for patients presenting with acute onset visual symptoms, in order to mitigate vision loss wherever possible.1
It has been clinically proven that successful outcomes for AMD improve with early interventions: immediate identification, precise diagnostic testing and urgent treatment for vulnerable, high-risk patients.2 Furthermore, early examination in such high-risk patients can offer insights into the cause of disease, which is essential for improving future patient diagnosis, treatment and management.3
Rebuilding clinics to adhere to the ‘new normal’
Our clinic staff have worked extremely hard to prioritise patients according to their signs and symptoms, in order to allow appropriate treatment delivery despite the limitations posed by the pandemic. Our greatest concern was the increased risk of vision loss and blindness in emergency cases.
We applied three changes early in the pandemic to reduce the risks to our clinical trial patient population and staff:
As the COVID-19 pandemic progressed, it became clear that we had to implement additional measures to further increase patient and staff safety. All staff are now tested for COVID-19 every other week and patients being admitted for surgery are also routinely tested.
Increasing waiting lists
Our public health system is unable to meet the requirements of all our patients nationwide. Those within the Spanish Health System (Sistema Nacional de Salud; SNS), like many other healthcare systems in the world, are subject to long waiting lists as the result of a growing and ageing population and of economic constraints.
Even before COVID-19, we were observing a growing demand for elective surgeries across most regions of the country. A report published by the European Observatory on Health Systems and Policies in 2019 stated that the average waiting time for cataract surgery, for example, increased from 90 days in 2010 to 100 days in 2018, with patients sometimes waiting 150 days for surgery appointments.4
I have personally witnessed the limitations on the volume of patients we can see at any one time due to the regulations that have had to be enforced this year. I suspect this will add further burden and strain to these waiting times as we look to recovery.
Our priority needs to be alleviating this burden so that the needs of our patients are met in a time-efficient manner. Preventing vision loss does not just benefit patients but has a huge impact on the healthcare system as a whole.
Opportunities arising from the COVID-19 pandemic
The question that remains is whether COVID-19 regulations and the new normal we are adapting to will accelerate innovation and change so that we are better able to meet our patients’ needs. While virtual methods of clinical research have been the subject of discussion across many medical specialties, the ophthalmic sector has been cautious in its approach.
Not only do we have a complex regulatory environment across Europe that varies from country to country, but also a dependence on device-led diagnosis and treatment management that makes it difficult to address these barriers and introduce the innovation required to facilitate a change to our practice. For example, imaging modalities are cost-prohibitive if employed outside the clinic and many patients need intravitreal injections, which cannot be performed in the home setting.
However, what COVID-19 has shown us is that there are some things that can—and should—be conducted remotely. It can be argued that this should become normal practice if we are to continue to meet patients’ needs whilst optimising the safety of all patients and staff. As innovators and leaders within our industry we now need to rethink our approach, to adopt a less cautious mindset and to work to optimise treatment delivery and address the increasing prevalence of vison loss within our ageing society.
We have applied this approach at our research sites, prioritising and adapting our processes in a flexible and speedy manner so that we were able to continue running trials and seeing patients as needed. And we have seen tremendous support and continued engagement from our patients and staff, which has been critical to ensure this continuance.
We recently collaborated with an ophthalmology-focused contract research organisation (CRO), Ora, to help to reduce start-up times, optimise site feasibility and selection and optimise clinical trial delivery. Specifically, as we look to the future, we are working with the CRO across a number of key areas:
Pre-screening and e-consent
Modalities to improve the identification of eligible patients can be employed in combination with technologies to allow discussion and information transfer with patients away from the clinic. E-consent, which is increasingly becoming widely accepted, allows patients to consider their participation once eligibility has been confirmed. This would limit their in-clinic time, thereby reducing the travel and time demands on them.
Regulatory agencies have endorsed remote and alternate forms of monitoring aside from the on-site visit. It will be interesting to see how this develops whilst also ensuring the necessary support at the site level. Electronic investigator site files, GDPR-compliant remote access to electronic medical record (EMR) systems and other offerings represent a real opportunity in this area.
Virtual assessment modalities
Further advancements in imaging techniques may provide opportunities for virtual assessments and could see the development of ‘smart protocols’, where patient visits, in combination with telemedicine, are prompted from the results of tests conducted within the home setting, with the focus being on patient safety and convenience.
COVID-19 is a problem we face with uncertainty as a global community. However, in working closely with different stakeholders—patients, staff, CRO partners, industry and other sites—we can create a strong and streamlined collaboration that will benefit ophthalmology as a whole.
The future is bright
The future of clinical research in ophthalmology is certainly bright. This area has been growing, with a record number of new studies and patient participation across our centres. Europe, as a region, has numerous research sites of excellence, a huge amount of clinical trial expertise and many potential patients that can positively contribute to drive the development of various treatment modalities forward.
COVID-19 has, without doubt, affected the industry but we need to use this time as an opportunity for learning, growth and advancement. Together we can continue to push the boundaries of innovation, providing excellence in eyecare and clinical research while ensuring patient and site safety. Our ultimate goal is to provide our patients with what they need now and in the future.
Roberto Gallego-Pinazo, MD, PhD
Dr Gallego-Pinazo is based at the Unit of Macula of Oftalvist Clinic of Valencia, Spain, one of a group of 38 Oftalvist clinical sites located across Spain. The clinics are dedicated to prevention, diagnosis, treatment and innovation through ophthalmic research, clinical trials and the surgeries and treatments they can offer patients. Dr Gallego-Pinazo has no financial interest in the subject of this article.