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At the 2024 American Academy of Optometry meeting in Indianapolis, Dr Andrew Pucker describes a wealth of data on enrollment in North American clinical trials.

AAOpt 2024: Running the numbers on ophthalmic clinical trials

Dr. Andrew Pucker presented data on the performance of toric lenses under the stress of heavy digital device use at the 2024 American Academy of Optometry meeting in Indianapolis.

AAOpt 2024: Investigating the performance of a 30-day toric lens for patients with heavy digital device use

Pucker shares topline results from a study that investigated the difference in meibomobian gland morphology when measured with a Visante OCT versus an OCULUS Keratograph 5M.

ARVO 2024: Increasing accuracy in meibomian gland morphology measurements

At the 2023 AAOpt annual meeting, data was presented on the frequency of success of patients struggling with contact lens drop out getting back into daily disposable lenses.

AAOpt 2023: Success of getting contact lens dropouts back in daily disposables

Growing evidence supports dual therapy to slow progression.

Stating the facts about combination myopia management treatments 

Dr. Glenda Aleman discusses the importance of diversity in practices and how LEO is attracting more Latinos to the industry.

VEW 2024: Cultural competency in optometry

At Vision Expo West 2024, Glenda Aleman, OD, participated in a panel called, "Cultural competency in eye care," wherein she and other panelists discussed the power of diversity in a practice. Other panelists included Larry Jones, OD; Linda Shi, OD; and moderator Charissa Lee, OD, MBA, FAAO. You can watch the full recording of the panel 

Aleman also discussed the impact of Latinos en Optometry (LEO), an organization rallied around increasing the density of Latinos in optometry by encouraging students to consider eye care as a profession.

Dr. Glenda Aleman discusses the importance of diversity in practices and how Latinos en Optometry is attracting more Latinos to the industry.

Video Series

Conference

Click here to see our latest poll results: Have you or do you plan to implement myopia control into your practice?

This poll is for optometrists and eyecare professionals, only. It will close on Friday, September 10, 2021.

Poll: What percentage of your patients exhibit blepharoptosis?

Small hyperreflective retinal foci (HRF), identified on 

 images, mirror neuroretinal activated microglia that are involved in the pathogenesis of 

. HRF with specific features referred to as aggregates of activated microglial cells, may represent local neuroretinal inflammation that can be monitored on OCT images,

Elisabetta Pilotto, MD, and colleagues reported. She is from the Department of Neuroscience - Ophthalmology, University of Padova, Padova, Italy.

The investigators undertook a study in which they evaluated retrospectively the presence and amount of small HRF in the eyes of patients with different macular atrophic phenotypes, that is, bilateral geographic atrophy (GA), unilateral GA and macular new vessels (MNV) in the fellow eye, and extensive macular atrophy with pseudodrusen (EMAP), a rare and aggressive variant of atrophic AMD.

They defined HRF as “isolated punctiform elements of small dimensions, 30 μm or smaller, with intermediate reflectivity (similar to that of the nerve fiber layer) and without a shadow cone.” The foci were measured on near infrared reflectance (NIR) and blue wavelength fundus autofluorescence (FAF) images.

The HRF were manually identified, counted, and analyzed to identify correlations with the best-corrected visual acuity (BCVA), GA lesion size, some GA features (multifocal versus unifocal GA; presence versus absence of foveal sparing) and central retinal thickness (CRT), the investigators explained.

A total of 46 patients were included and classified as follows: 26 with bilateral GA group, 16 with unilateral GA and MNV in the fellow eyes, and 4 with EMAP group.

The patients with EMAP were younger compared to patients with bilateral and unilateral GA, ie, 63.5 ± 6.8 years vs. 80.4 ± 8.4 years (p=0.0004) and 83.3 ± 6.1 years (p= <0.0001), respectively.

The evaluated factors that did not differ significantly among the groups were the mean BCVA, mean GA area in the NIR and FAF images, foveal-sparing and multifocal versus unifocal GA distribution, and the mean CRT.

The GA areas were wider on the NIR images than the FAF images in all groups, and significantly so in the bilateral and unilateral GA groups: 11.7 ± 7.6 mm2 vs. 10.6 ± 7.1 mm2 (p = 0.0087) and 7.8 ± 9.2 mm2 vs. 7.7 ± 9.4 mm2, p = 0.004, respectively.

Significantly more HRF were present in the unilateral GA group compared to the bilateral and EMAP groups: 47.4 ± 7.1 vs. 31.6 ± 7.3 and 28.0 ± 4.9, respectively; p < 0.0001 for both comparisons), The bilateral GA and EMAP groups had similar numbers of HRF (p = 0.1960).

A correlation was found only between the numbers of HRF and the CRT, that is, a positive correlation with the bilateral GA group and a negative correlation with the unilateral GA group.

“The increase in the small HRF, which mirrors retinal microglial activation, characterizes eyes with unilateral GA and MNV in the fellow eye) but not eyes with bilateral GA or EMAP,” the investigators commented.

They emphasized that the role of activated microglia in the retina of eyes with GA should be investigated further with consideration of “actual and new therapeutic strategies with which to reduce either the development or progression of the atrophic macular changes.”

Pilotto E, Parolini F, Midena G, Cosmo E, Midena E. Small hyperreflective retinal foci as 

 imaging feature of resident microglia activation in geographic atrophy. Exp Eye Res. 2024;248:110064; 

https://doi.org/10.1016/j.exer.2024.110064

Study authors defined hyperreflective retinal foci as “isolated punctiform elements of small dimensions, 30 μm or smaller, with intermediate reflectivity (similar to that of the nerve fiber layer) and without a shadow cone.” 

Canonical

Study suggests that small hyperreflective retinal foci may represent local neuroretinal inflammation

Dr. Mark Bullimore investigates myopia in an omnibus model at AAOpt 2024

AAOpt 2024: Looking at myopia in an omnibus model

At the 2024 American Academy of Optometry, myopia expert Mark Bullimore, MCOptom, PhD, presented a poster titled, "Efficacy in myopia control: An omnibus model." In the poster, Bullimore investigates the definition of "normal progression" in myopic eyes and the change of efficacy over time. 

I am Mark Bullimore. I reside in Boulder, Colorado. I'm affiliated with the University of Houston College of Optometry. We're in the early days of myopia control. If you think about glaucoma, we know what normal pressure is, we know what target pressure should be, we know how to interpret the efficacy of our surgical and pharmaceutical treatments. With myopia, we're still learning. The two aspects of the poster cover what is normal progression and how does efficacy change over time.

To talk about the first aspect, we know from our systematic reviews that Asian, myopic children progress about 40% faster than their white or European-descent peers. We also have shown that axial elongation, which drives myopia progression, that slows by about 15% per year. So a 12 year old is elongating or progressing at about half the rate of an eight-year old myopic child. That has a number of ramifications. First, we should treat younger children more aggressively, and we should institute treatment as soon as possible, because that younger myopic child is not only progressing faster, but they have further to go before their myopia stabilizes.

The other aspect that we're talking about is a better understanding of the efficacy of myopia control. One thing that's important to remember is that the treatment efficacy is greatest in the first year of treatment. What that means is that efficacy is going to be poorer in the second year. From a clinical perspective, you may see faster progression in Year 2 of your management of the child compared to Year 1. So that's something that you want to be aware of. The other thing that we've shown is that you can accurately predict the three-year efficacy, the three year slowing of elongation and progression from the one-year efficacy, and that has ramifications for how we might do clinical trials in the future.

Our analysis of myopia control efficacy includes all the possible modalities, be they contact lens, spectacle, or pharmaceutical. We really don't have long-term data on red light therapy, but we've looked at all of those modalities, and the conclusion really applies across all of them. The treatment effect in Year 2 is about half the treatment effect in Year 1. I think one of the important things to come out of the study is to demonstrate to the practitioner what is average progression as a function of age and race, and that allows you to set expectations of what you would see without or potentially with treatment.

The other thing that we're focusing on is what is a reasonable expectation in terms of the slowing or the progression that you're going to observe under treatment, and what should you be able to promise long term to the attentive parent that's also in the room with the child. I think one of the take homes from the data and the analysis is that the younger children are progressing more quickly, and you should be choosing your best evidence-based therapies for those children, and really consider a combination therapy of a pharmaceutical and an optical treatment, right off the bat, particularly if that child has other factors, like they're East Asian that mean that they're going to progress more than a white child.

It's important you stay up to date with the published literature, particularly the peer-reviewed, evidence-based literature, and whether you choose to read it yourself or digest it through newsletters or talking heads like myself. You need to be up to date, because it is a rapidly evolving field.

The other thing that we should avoid in practice is overpromising to parents. Myopia control rarely stops progression. There will be some progression, and there will be progression over time, so you've got to stay with it, but at the same time set reasonable expectations.

In an AAOpt poster, Dr. Mark Bullimore investigates the definition of "normal progression" in myopic eyes and the change of efficacy over time.

At AAOpt, Dr Andrew Pucker discusses data collected on ophthalmic clinical trials.

Running the numbers on ophthalmic clinical trials

Optometrists are well-aware of the critical role clinical trials play in advancing eye care treatments and technologies. However, one of the most common challenges faced in these trials is meeting enrollment targets within the desired timelines. At the 2024 American Academy of Optometry meeting in Indianapolis, Indiana, Andrew Pucker, the Executive Director of Clinical and Medical Science at Lexitas Pharma Services, presented valuable data on enrollment rates and trends in the North America region, offering key insights for optometrists involved in clinical research. 

Pucker's team conducted a comprehensive analysis of every clinical trial registered in the United States, breaking down the data by study phase and common ophthalmic indications, such as glaucoma, dry eye, and macular degeneration. This level of granularity is invaluable for researchers and sponsors planning new trials, as it provides realistic benchmarks for enrollment, site requirements, and study duration. For example, the data revealed that a typical phase 2 dry eye study requires approximately 100 subjects and 20 clinical sites, with an average completion time of 6 months. Armed with this information, researchers can more accurately forecast resource needs and budgets, ultimately improving the chances of successful enrollment and timely study completion. 

Beyond the specific metrics, Pucker's analysis also highlighted the dominance of certain industry players in the ophthalmic clinical trial landscape. Alcon and Allergan emerged as the most prolific sponsors, underscoring their commitment to advancing eye care innovations. This knowledge can help optometrists identify potential collaborators and stay abreast of the latest developments in their respective fields. 

Pucker's work serves as a valuable resource for the optometric community, bridging the gap between the theoretical and practical aspects of clinical research. By understanding the nuances of enrollment trends and sponsor activities, optometrists can better position themselves to participate in cutting-edge trials, contribute to the advancement of eye care, and ultimately, provide their patients with access to the most promising treatments. The full dataset and analysis are available in the 

 journal, and Pucker has graciously offered to share his presentation poster with interested parties. As we continue to navigate the evolving landscape of ophthalmic clinical trials, this information can prove instrumental in optimizing enrollment, streamlining study design, and driving innovation in the field of eye care.

Dr Admad Fahmy overviews a presentation on corneal nerve dysfunctino and OSD

AAOpt 2024: Addressing corneal nerve dysfunction in ocular surface disease

Alongside Walt Whitley, OD, MBA, FAAO, Ahmad Fahmy, OD, FAAO, gave a presentation entitled, "Management of Neurotrophic Keratitis and Corneal Neuropathic Pain," at this year's AAOpt meeting. Fahmy is an optometrist at Minnesota Eye Consultants, founder of the Twin Cities Ocular Disease Symposium, and cofounder of Eyes on Dry Eye.

Editor's note: The below transcript has been lightly edited for clarity.

Hello. My name is Ahmad Fahmy. I'm a Doctor of Optometry at Minnesota Eye Consultants. I'm the founder of the Twin Cities Ocular Surface Disease Symposium and the cofounder of Eyes on Dry Eye. I just gave a presentation at the 2024 Academy meeting here in Indianapolis with [Dr] Walt Whitley on corneal nerve dysfunction in ocular surface disease. So the key takeaways, and I think we did a good, compelling case of really the importance of looking for corneal nerve dysfunction in ocular surface disease. The main takeaways is that corneal nerve dysfunction can show up in an underactive way. It can also be overactive, and it's important for us to be testing for these patients, the corneal sensitivity, and doing a proparacaine challenge in patients we suspect might have a central component.

So misconceptions, some of the things that sometimes can be really troubling for these patients that have a more of a neuropathic component, is that sometimes the clinical picture looks pretty good, [but] we don't really address their pain aggressively enough. And so it's important for us to do a proparacaine challenge in these patients and when we identify a central component, it's important to be thinking about comanaging these patients with a pain specialist.

So the severity of the pain can be really understood, better understood by just listening carefully to that patient. In my experience, these are patients that usually come in very sensitive to light and just really struggle to do any computer work. So it's really important to be thinking about the treatment for these patients, is to decrease the inflammation and really try to get normal nerve regeneration in these patients.

Human nerve growth factor is really my go to medication, topical medication for improving the inflammation and getting better corneal nerve health, reestablishing better corneal nerve health. And a lot of these patients, I'll end up using other regenerative types of medications like amniotic membrane and platelet rich plasma, autologous serum, and again, co managing these patients with a pain specialist, I think, is really critical.

So one thing I would really like to touch on, too is that sometimes we don't think of it early enough. But also, scleral contact lenses can be very helpful. Specialty types of contact lenses can really help these patients. In my experience, the patients that end up doing a little bit better with a specialty type of lens or a scleral contact lens are the ones that really don't have as much conjunctival inflammation. And of course, we want to stay away from doing a scleral contact lens in patients that have a trabeculectomy. But scleral contact lenses can be really helpful in patients with any kind of coronial nerve abnormality. Honestly, I don't really do a lot of the contact lens fitting myself, but I know that that contact lens really has to be a really good fit in order for it to really help these patients, because, again, inducing a little bit of inflammation is the main thing we're trying to avoid. So it's really critical to get just a really an excellent fit. And so I'm really fortunate to be working with a lot of my colleagues that do just a phenomenal job in fitting these patients with sclerals.

Alongside Walt Whitley, OD, MBA, FAAO, Ahmad Fahmy, OD, FAAO, gave a presentation entitled, "Management of Neurotrophic Keratitis and Corneal Neuropathic Pain," at this year's AAOpt meeting.

Andrew D. Pucker, OD, PhD, FAAO, FSLS, FBCLA

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