The secondary effects of the coronavirus continue to snake their way into unexpected sectors of the economy and the medical field. Indeed, it seems as if the virus is leaving no stone unturned in its preternatural ability to highlight any and all flaws in established systems or practices.
One area noticeably affected by the coronavirus is the realm of corneal transplants. Essentially, cornea transplants have been halted worldwide. Indeed, the tone set in the field is eerily akin to that experienced in blood banks and blood transfusions during the early days of the AIDS epidemic. Can COVID-19 be spread through the corneas of deceased patients? Can corneas be tested to see if they carry the virus? Are cornea transplants, like many medical procedures not related to COVID-19, being put on the back burner — with many left to suffer?
To answer these questions, CAKE and Geuder AG teamed up with three experts from around the field of corneal transplantation: Monty Montoya, CEO of CorneaGen; Hamadi El-Ayari, VP of sales and marketing at Geuder AG; and Dr. Jayesh Vazirani, cornea and ocular surface disorder expert based in Ahmedabad, India.
Geuder AG develops, produces and markets ophthalmic instruments and systems for the latest surgical techniques, including instrumentation for corneal transplant procedures. They’re one of the industry’s heavy hitters when it comes to ophthalmic products.
CorneaGen is the largest supplier of corneal tissue in the world and has a profound impact on corneal procedures worldwide.
Cornea Transplants Grinding to a Halt
The fact that in the U.S., nearly all cornea transplants have stopped is absolutely unprecedented. CorneaGen — which, again, is the largest provider of corneal tissue for transplant in the world — is operating at about 5% of capacity or perhaps as high as 10% in some places. According to Mr. Montoya: “In a [usual] week, CorneaGen would provide 350-400 corneas for transplantation. This week, we sent out somewhere in the neighborhood of 32 for domestic transplant.”
Meanwhile, the questions keep piling up. Mr. El-Ayari summed these questions up succinctly: “Cornea banks — what is their current standard? Do they test when they get recipients? When they get harvested corneas, do they test them for COVID or not? Is there a difference in how they do it in Italy, than in the Netherlands, in the U.K., or the U.S., where they’re currently not testing at all? Will this change? Will we have a massive lack of corneas because of that? Because we are wasting so many right now.”
Mr. Montoya has answers for some of these questions. “Currently in the U.S., we use short-term cold storage, so there is not a testing process to the way we practice eye banking . . . so there is no [COVID-19] testing per se that’s being done on donors,” he said, adding that they follow screening guidelines from the CDC and the WHO.
So, will there be a lack of corneas? Possibly — but Mr. Montoya also sees other procedures taking precedence over corneal transplants. “I anticipate that things will begin to open up in June and July . . . but as this happens there’s also a backlog of cataract, MIGS and refractive patients,” he explained. “I think it’s very possible that a lot of surgery centers and ophthalmology practices will be in a position where they need to prioritize those patients, so the cornea transplant patients may need to wait longer.
“It could be until October before we see things in corneal transplantation back up to 100 percent — and by then we may have more demand than we actually have the tissue for,” said Mr. Montoya.
Partially because of these uncertainties — and partially because some cornea transplants aren’t deemed as necessary as others — the surgeries have essentially stopped worldwide. “In the U.S., for example, they have a list of surgeries you’re allowed to do as a surgeon, and the others have to be postponed,” said Mr. El-Ayari.
Add to that logistical complications due to national lockdowns, and the gravity of the situation becomes more clear.
“In India, all corneal transplant activity has come to a complete standstill over the past few weeks,” explained Dr. Vazirani. “The only exceptions would be a minuscule number of tectonic grafts done at some centers. This is due to two reasons. First, eye banks have stopped harvesting donor corneas. Second, the entire country is under a lockdown and there is no transportation available even for the few corneas already present within eye banks.”
Because cornea harvesting has all but stopped worldwide, shortages in the future appear guaranteed. As Mr. El-Ayari pointed out, corneas in cornea banks do not last forever. Similarly, Dr. Vazirani noted that corneas could be moved to safer long-term media of storage in the future, but doubts that will happen due to high costs.
For many years the U.S. was exporting corneas. Now, however, corneas from countless potential donors will have to be thrown away due to concerns they’d be infected with COVID-19. Mr. El-Ayari predicts the U.S. will not be a net exporter of corneas in the future anymore. He envisions a shortage of corneas over the next 12-24 months as a result, with surgeons having to compete to get what they need.
Mr. Montoya thinks that once things begin to normalize, there will be an overwhelming demand for tissue — and for the first time in decades, there will be more demand than actual tissue.
India, similarly, is being forced to stop collecting corneas, citing concerns for medical workers as well as patients. “In accordance with an advisory put out by the Eye Bank Association of India (EBAI), all activities related to harvesting human corneas have stopped,” said Dr. Vazirani. “This has been done as there is great uncertainty about the risks to eye bank technicians who harvest corneal tissue.”
Dr. Vazirani, like many eye surgeons in India, relies on a national network of eye banks called the Centralized Distribution System (CDS) for his corneas. “At present,” he said, “as eye banks are not harvesting corneas and there is no transportation, we have no access to corneal tissue.”
Patients Put on Hold
Consequently, many patients are unable to get the treatment they need.
Dr. Vazirani notes that he fortunately does not have any patients who currently need urgent surgery. He is uncertain about how long to tell his patients they will need to wait, but says a minimum of two months and probably more.
In the meantime, however, what kind of patients would need surgery in a hurry?
Mr. El-Ayari pointed out that when there is an accident that results in damage to the cornea, it needs to be treated immediately. Young children, especially, need to receive treatment as quickly as possible since damage to eyesight can be permanent if left untreated.
What About Testing?
Many countries around the world are facing shortages of test kits for COVID-19 — and that’s for living patients. Testing corneal tissue does not appear to be a priority for many countries.
“In India, we have an extremely limited number of testing kits for COVID-19,” said Dr. Vazirani. “There are rigorous guidelines regarding how these can be used, so we do not have the luxury of testing either donors or recipients for COVID-19 at present. The situation is expected to improve with time.”
Mr. El-Ayari noted that the U.S. is testing corneas for many things, including HIV and other diseases — but not yet for COVID-19.
The largest cornea bank in Italy, however, is testing each and every harvested cornea to make sure it’s not infected with COVID-19, thus bypassing the need to put the corneal tissue in quarantine. Mr. El-Ayari expects other countries to soon follow suit. This uplifting bit of news could set a new standard for corneal testing and pave the way for a return to normal — or at least something like normal.
An Uncertain Future
Until now, there has been a worldwide market for harvested corneas — and some countries, like the U.S. and Italy, had an excess of them.
“This will have a ripple effect around the globe because a huge percentage of the U.S. corneas are sent to countries all over the world . . . so the supply for those countries who also have a backlog will also go down,” shared Mr. Montoya.
In addition, there is a potential for national pushback against sharing organs across borders as globalization retreats worldwide, leading to lower availability for transplants. However, Mr. El-Ayari argues that when there’s an excess of donor organs, sharing them across borders is an ethical issue — regardless of the organ. In this circumstance, it’s corneas. But anything that can save lives or improve quality of life can fall under the same purview.
In the middle of a crisis like this, perspective is very hard to achieve — like grasping the size of a forest from the inside. We’re clearly not out of the woods yet, but some signs are positive, like the testing protocols initiated in Italy. Corneal transplants may be one small facet of the medical world, but they represent an important microcosm of the current state of affairs. The situation may be bewildering, but it gives us an opportunity to explore our shared humanity and work together towards a common goal.