As we watched the first COVID-19 case reports on the news in mid-February 2020, my mother and I were discussing our family plans to cruise the Norway fjords that summer. She insisted at the time that I cancel the cruise before final payment, and I remember thinking that she was overreacting. Little did I know that in just a few weeks she would turn out to be right (yet again!).

Everyday life has changed in a multitude of ways in the last year, including for retina specialists. We have all made myriad changes in clinic processes that have allowed us to see our patients effectively since the pandemic began. We have also had to adapt our workflow in clinical trials to continue to offer these innovative treatment options to our patients safely.

Budget

In the middle of March 2020, our office was offered a “deal” on 5 boxes of surgical masks at $4 per mask, which we had to act on fast. We were just realizing at the beginning of the pandemic that there was a severe shortage of PPE. Without masks, we were not going to be able to see our patients safely, and our clinics would be closed. We bought them.

Fortunately, the price gouging did not last long, and the price of PPE came down. However, clinical trial sponsors quickly realized that the cost of seeing each patient was much more than the prepandemic cost, due to the extra PPE and staffing costs associated with each encounter. Adjustments have been made in each study budget to factor in these extra costs.

Recruitment

At the beginning of the pandemic, we knew very little about COVID-19. How transmissible was it? How deadly was it? Even young doctors had to think about whether they had a will to continue seeing patients. Many general ophthalmologists and optometrists shut down their practices altogether. Most retina specialists cut back their practices to emergencies only.

Unfortunately, any drop in clinical volume, especially a drop in new referrals, leads to a drop in new patient recruitment for clinical trials. Trials are often looking for treatment-naïve patients, and an important source of these patients is lost when referring physicians close their doors.

Fortunately, as the year has progressed, and referrals have resumed, clinic volume has increased. With careful workflow modulation, planning, and spacing, we have been able to restore clinic volume to levels near prepandemic levels. Similarly, although clinical trial volume was initially quite low in parallel with clinic volume, our clinical trial department has been able to gain recruitment volume as well.

We keep recruitment strong with “be on the lookout for” update emails and postings to staff, photographers, and doctors. Study coordinators prescreen consults and flag charts that may be potential study subjects.

However, it can continue to be a challenge to recruit for trials during the pandemic, because patients are more reluctant to join a study with required monthly visits due to concerns about COVID-19 transmission. For instance, before the pandemic, patients were delighted to join clinical trials that reimbursed transportation costs to and from clinical trial appointments. Since the pandemic started, some patients have had concerns about exposure while being transported to the appointment, and some patients who live far away from a clinical trial site are less likely to join a clinical trial.

Similarly, patients with conditions that are usually monitored without active treatment, such as nonproliferative diabetic retinopathy, or geographic atrophy, may be less enthusiastic about joining a study with required monthly visits in the middle of a pandemic. Hopefully, increasing rates of COVID-19 vaccination in the patient population will help ameliorate some of these concerns about COVID-19 transmission risk from study visits.

COVID-19 Precautions and Protocol Modifications

Regardless of whether the patient was involved in clinical trials or not, it became imminently clear that the process of delivering high-quality care needed to be expedited to maximize social distancing. The shorter the time the patient spent in the clinic, the better. In the early days of the pandemic, it seemed that only about half of the patients understood that their mask had to cover both the nose and the mouth to be effective, and that their mask did not have to be removed during the slit-lamp exam.

Our patients have been scheduled so that they can safely be seen with enough time between appointments for ample equipment sanitization. Instead of waiting in the subwaiting rooms, they are kept in the exam room for the duration of their appointment so they have a private, clean space for their visit. Clinical trial sponsors have amended and modified protocols to shorten intervals between treatments and intraocular pressure measurements, for example, in order to shorten study visits. In some cases, sponsors have waived some required measurements or visits to decrease the time burden on patients.

Clinical trials involving surgical procedures, such as the Genentech Port Delivery System trials, had to undergo some protocol modifications, given that elective surgeries were on hold for months at most clinical sites. Even after resumption of elective surgical activities, limitations on clinical observers required for supervision limited trial activity at some clinical trial sites.

Home Monitoring

Unfortunately, none of the trials that we are involved with at our site have offered home monitoring for our patients. Although products such as the Notal OCT obtained FDA breakthrough device designation in December 2018, clinical trials still rely on stringent best-corrected ETDRS visual acuity measured in standardized 4 meter lanes and protocol-obtained OCT images to preserve data integrity.

The Virtual Meeting Room

For the last year, our study initiation visits have all been held remotely, over platforms such as Zoom, and this has worked quite well. This may indeed persist after the pandemic. We have all become well versed at sharing screens and looking over slide shows over Zoom, so virtual study initiation visits could be continued in the future.

Study monitors were actively discouraged from visiting us during the early pandemic. The feeling was mutual – nobody on the sponsor side was interested in hopping on a plane, sharing potentially infected air with strangers, and visiting strangers in a different city. We all tried to make everything work out virtually. However, when the study monitors tried to do some remote monitoring visits, they quickly found that poring over paper files and binders virtually was impossible. When it became safer to travel, study monitors were allowed back into the office. We have found that it works best to limit the study monitors to 1 monitor per office per day, for obvious spacing purposes.

Investigator meetings, like all meetings, have been virtual as well this year, and again, this has worked very well. This may again be the paradigm for the future. Whereas investigators and study staff would previously have to take precious clinical (or research) days off to travel to these meetings, several virtual sessions are typically held so that the investigator and study staff can attend the session that is most convenient for their schedule. The downside of this, as with all virtual meetings, is that the valuable interaction between investigators outside the meeting room is lost. A remedy to this in the future may be to hold short investigator updates and breakout sessions in tandem with in-person large retina meetings such as the American Society of Retina Specialists and the American Academy of Ophthalmology’s Subspecialty Day. Of course, if we return to in-person meetings after COVID-19 is controlled, retina doctors may be seeing each other on a regular basis, since there seems to be a retina meeting scheduled every weekend.

Staffing

This year has been extremely stressful for everyone. As health care workers, we are chronically tired and stressed. Not only are we afraid of getting sick ourselves, we fear that we may bring sickness instead of healing and love to our patients and our families. As parents and caregivers, we worry about our children and their education, and can feel upset that there is little supervision at home.

These stressors understandably took a toll on some of our staff. Others missed work because of COVID-related illness or concerns that they could have COVID-19. Before we had good testing turnaround times, a staff member could miss a whole week of work waiting for a COVID test result.

For a combination of reasons, the number of missed working days in both our clinic and in our clinical trial department was higher this year than in prior years. Due to both staff coverage needs and clinical trial department expansion, we have been hiring more new staff this year. This gives us the opportunity to refine our training programs.

Conclusion

We have had to adapt our clinic workflow to see patients safely and efficiently in the face of the COVID-19 pandemic. In the clinic, patients now expect to see a socially distanced, empty-looking waiting room, and start to grumble if they wait for more than an hour.

Similarly, we have also adapted our clinical trial workflow to best accommodate our study patients so that sight-saving research can continue to be done even in these challenging times. Our clinical trial department, which along with our clinics, saw a dramatic dip in activity in spring 2020, has recovered its prepandemic recruitment volumes. We are in the process of expanding our clinical trial department in both staffing and physical size to handle the increased demands of the upcoming, exciting trials that are on the horizon.