Lexitas’ Best Corrected Visual Acuity Certification program, powered by Pro-ficiency’s virtual simulation technology, is a best-in-class solution for training and recertification of visual acuity testing. In this video, Dr. Sally Tucker and Dr. Andrew Pucker discuss visual acuity testing in clinical trials, how the Lexitas BCVA program was developed, and the types of trials that would benefit from the program.

The following is a transcript of the above video.

Dr. Sally Tucker: Hello to our audience. My name is Sally Tucker and I’m President of Global Services here at Lexitas. I’m an optometrist and I have dedicated my entire career to the field of ophthalmology, having joined industry back in 2023. I joined Lexitas where I am honored to have a coworker who is also an optometrist, Andrew Pucker, who joins me today. Can you tell our listeners about yourself and what you do at Lexitas?

Dr. Andrew Pucker: I am an optometrist, and I’m originally from Wisconsin. I decided I wanted to be an eye doctor one day from looking at a book, and that’s kind of led me down this journey. I did job shadowing of course as well, but I went to the Ohio State University where I completed my optometry degree. I simultaneously completed a master’s degree in tear film chemistry and contact lenses, and I loved academia so much that I stayed on for a PhD where I studied myopia development under Don Mutti.

With that, I got a NIH grant, which helped me get my first faculty job at the University of Alabama at Birmingham, where I know Sally has done some work as well. I eventually wanted to change my life up again. I wanted a remote work position, so I started searching around and I found Lexitas. It’s been a great fit over the past three years. At Lexitas, my job is essentially being a research coach for companies. I help companies develop their protocols. Once the protocol is written, I then help provide medical oversight on trials as the medical monitor. And when I have a little free time, which doesn’t happen a lot, but when I have a little free time, I help with developing new offerings like the one we’re going to talk about today.

Fantastic, yes, I was in Alabama. I don’t think our paths crossed there, but I was there for four months during my PhD that I conducted in the early 2000s. Yeah, a wonderful time. So one of the new offerings that we have developed here at Lexitas is for best corrected visual acuity. So can you tell us what is visual acuity testing?

I think visual acuity is one of the quintessential tests of eye care. I think it’s what most patients think about when they go to see the eye doctor. What typically happens is the patient sits in the exam chair and then they look at a eye chart at a fixed distance. It might be a simulated twenty feet away or maybe four meters, depending upon what you’re testing.

What you typically do is read the eye chart starting at the top, and then you read each line and keep going, reading letters, and reading letters until you can’t go any further. This is a measure of visual potential. The eye doctor is trying to see if you can read what they consider to be relatively normal. So are your eyes healthy enough to read a standard line that most people should read?

Historically, we’ve used what is called the Snellen chart. It’s the chart with the big letter E on top that most people think about. You might even have like one of those saying photos in the back of your house where it’s like, “I love wine” or something, but it’s kind of shaped like an eye chart with the big E on the top.

The Snellen chart works really well in the clinical setting. It can help you do your refraction—so determining your glasses, prescription, et cetera. The main pitfalls of that chart is that the lines are not evenly spaced and the letter sizes are kind of all over the place. The big letter E on the top is a 20/400 letter E. Then it jumps to a 20/200 line, then it goes to 20/70, and it keeps getting smaller increments. So it’s not evenly spaced, which makes it kind of a poor choice for a clinical trial because you’re not really seeing if there’s incremental difference in visual acuity. So you might be missing some really critical information.

This led to the development of LogMAR charts. The first one was the Bailey-Lovey chart, which was, I think, in the late seventies. Then the ETDRS study, so “Early Treatment of Diabetic Retinopathy Study” developed what we typically use in clinical trials. It’s a LogMAR chart, and the lines are evenly spaced. With that, we can determine if there really was a clinically meaningful difference in this patient’s vision across the trial, if you’re looking at the safety issues or even an efficacy endpoint.

Why do you measure visual acuity in a clinical trial?

Pretty much every trial we run at Lexitas uses visual acuity in some manner. You typically use it as a safety outcome. So you have a person start a study, they’re starting a new device or drug, and you want to make sure that their vision’s not getting worse. We want to give people products that are going to have a really good safety-benefit ratio. We don’t want their vision to get worse. So that’s probably the most common reason we would test visual acuity in a trial.

However, some trials also use it as an efficacy measure. That’s more common in retina studies, in my opinion. Maybe a gene therapy. So maybe your retina is missing a protein. You take a treatment that helps your body make that needed protein, and maybe your vision gets better. In that, it may actually be a primary outcome from your study, and you want to measure really well with one of those LogMAR charts.

For a lot of these trials, you often hear of sites having to undergo a best corrected visual acuity certification program. Can you talk about what the Lexitas Best Corrected Visual Acuity Certification program offers and why it is done?

Any procedure in a study has a set thing that you have to do with it. Like there’s a manual procedures you have to follow. However, sometimes you really want to get it perfect. Like we want everything to be perfect, but there’s a give and take in studies, right? So we have a pretty rigorous measure of visual acuity in all of our trials.

However, sometimes we want to take it to the next level. And that’s where the best corrected visual acuity certification comes in. At Lexitas, we have a program that has a set of modules. So they’re learning immersive modules that provide feedback along the way, which this program was developed in conjunction with a company called Pro-ficiency, who has AI technology.

So we have me as the moderator, and I’m actually an avatar for half of it. So they have me with this AI technology walking our testers through this very rigorous program that’s based upon our manual that they’re supposed to follow. With this, as I mentioned, they get feedback along the way. There’s knowledge checks, and they’re not allowed to progress until they get the questions right. Which is, I think, really helpful. You have standard certification programs out there where you just kind of read the module and maybe watch some YouTube videos, but you could do that really passively. We are all busy, and we may be multitasking doing email that sort of thing. Our program doesn’t really allow for that because you have to follow along in real-time and get the questions right to progress all the way through.

An added advantage of that system is behind the proficiency platform there is a tracking of everyone’s metrics. If we have a study, and we know that they’re not doing well at shining the right lens in front of the patient’s eye at a specific point, we have that knowledge at hand when we go to the sites to do their full certification. They do these modules online, our CRA goes to the site, and then they do the onsite knowledge check to make sure that they’re doing things correctly.

As I kind of alluded to, if they know that there’s one specific thing they’re really sucking at that site. They can focus on that when they’re doing the training to make sure that remaining pitfall or hurdle is cleared so that when they actually are seeing subjects in your trial, they’re going to do it perfectly every time. And they’re going to get down to that last potential letter on that chart that the patient can actually potentially see.

There are other BCVA programs out there, so can you explain how the Lexitas program compares to those?

So I haven’t seen every program out there, but what I can say is that most programs have a manual, and then they may have some videos that help as a tutorial. But with the Lexitas program, it’s an immersive learning experience which you really you can’t passively do. You actually have to engage in it and run yourself through the program which is, I think, completely different than everything else on the market, at least that I have seen. That, in my mind, is the biggest advantage from a learning perspective with our program over others.

What trials would benefit from the BCVA certification program?

I think the best trials for a certification program are where you have visual acuity as your primary outcome or maybe a key secondary outcome. Probably it’s going to be an efficacy outcome. You have a patient who’s in a retinal study. It’s a gene therapy study. We want to see, did that person’s vision actually improve three lines or more, which is a common standard set by the FDA in the United States, at least. We want to actually capture that down to the letter. These charts are often scored by how many letters you get correct. So if we can get every letter read that’s potentially read, that I think is going to get you closer to meeting your end points and getting your drug approved.

It’s ultimately about consistency across sites in what can be an incredibly important measurement in a clinical study, isn’t it? I don’t know if you have anything you want to add about the Best Corrected Visual Acuity Certification Program, but I have had the pleasure of walking through it. Apart from the fact that we have come as close as you can to cloning Andrew Pucker, it really is a fantastic program. And I can see how it can be used to collect metrics and to provide that assurance of consistency across sites.

I think Sally had a great point just a minute ago there. I think this really helps with site-to-site consistency, and with the AI technology that’s built into our system, I could potentially speak any language. So if you are going to run a trial in the United States and France and China, potentially, you could have, of course, for an additional fee, an add-on of translation that could translate our program specifically to each potential tester for each country. I think that, again, is a huge advantage over a lot of our competitors out there. I’m sure they have ways to work around that, but everything for us would be integrated.

A couple of other advantages with ours is that it’s all within your CRO. Lexitas would be running your trial, and we would also be running your certification program. So we’d be using the same CRAs that go to activate your site to train your people on doing the certification. That would eliminate a visit to your studies’ practices so that’s easier on them. They have one fewer thing they have to manage, they have a single point of contact. Say you have issues with your study, like a PD comes up. You know, a protocol deviation, but you’d ask the same person about a protocol deviation as any sticking points that you would have for your certification program. There’s lots of little advantages that we’ve tried to work in there, and that also results in a cost savings.

To learn more about the Lexitas BCVA certification program and discuss how it can support your upcoming trial, contact us about speaking with an expert.

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