Another Good Idea Dies In The Nest

The virus that is responsible for the current COVID-19 pandemic is new, or novel. As such, its behavior in nature and within the people who are unlucky enough to host it is not fully understood. What is clear is that the virus can be recovered intact and viable from the tears of infected people. The concentration of the virus within the tears likely varies between people and likely also varies depending on what stage of the infection people are in. It is also clear that a large percentage of people who are actively infected and also contagious are unaware of their clinical status. It is believed that something like 40% of COVID-19 virus transmission is generated from asymptomatic people.

I work in a private practice around 30 miles southeast of St. Louis. My practice is called Comprehensive Eye Care. We deliver comprehensive eye services to people of all ages. Because we serve a diverse population, these patients have a considerable variety of needs. In the clinic, there have been numerous modifications implemented to help the eye doctors and their staff render appropriate care for this diverse population while minimizing their likelihood of contracting this potentially lethal disease from patients. These precautions are also designed to likewise protect the patients from the doctor and their staff while they are being cared for. The traditional method of sterilizing the tip of the device that touches the eye during the eye pressure measurement is to wipe it with an isopropyl alcohol pad before and after use. This may or may not be sufficient to prevent the transmission of COVID-19 from person to person through the tears, and handling the alcohol pad with an ungloved hand may also be an imperfect strategy. Most practitioners do not use gloves in the eye clinic when checking patients' intraocular pressures. Even if a patient contracted a COVID infection from having their eye pressure checked, there would literally be no way to track and confirm this. Here is an opportunity to create and deploy a "best-practice" solution.

The best strategy is to use a disposable cover that can be affixed to the front surface of the tonometer tip with a forceps, and then removed with the same forceps after the eye pressure is obtained. The forceps would never touch the portion of the membrane that makes contact with the patient's tear film. The disposable cover would need to prevent the virus from traversing the membrane while it is in place and being used. It also would need to have physical and handling properties that protect the practitioner while it is being used.

I have invented and prototyped just such a forceps, and I have tested several commercially available clear membranes that can be reversibly affixed to the front of the Goldmann Applanation Tonometer tip and permit an accurate and precise measurement of the intraocular pressure, when compared to measuring the intraocular pressure with the same device, on the same patient, at the same time of day, without the membrane. The handling of the membrane never puts the practitioner at risk for contamination, and it is easy to handle. The membrane is waterproof, and as such, it is highly unlikely that any virus would be able to traverse the membrane over the 5 seconds of contact that the membrane makes with the patient's tear film. Of course, that would need to be confirmed, but from the armchair, it is very likely a safe and effective prophylactic.

Now I have it, and nobody else does. What happens next?

Valuable, practical, and effective devices "suffer" from the requirement of receiving FDA approval before they can be put into general practice and sold or distributed to the general population. Proving a treatment that is both safe and effective is, of course, important, but it comes with an entire portfolio of functional impediments. This is true even when the reason for using such a device is important and immediate, like it is for solutions to the COVID virus challenge. Getting a device FDA approved is both time consuming and expensive. First, a company would be...