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Danielle Crull, ABOM, details Truffles' story and new initiatives she has taken on to destigmatize glasses and patching for children.

A glasses-wearing kitty?: Truffles and her impact on eye care, one pediatric patient at a time

Danielle Crull, ABOM, of A Child's Eyes discusses what is now possible at her glasses dispensary that was not previously possible without Truffles.

A glasses-wearing kitty?: What contributes to Truffles' success

Truffles the Kitty has helped put A Child's Eyes patients feel more at ease when being fitted with glasses while taking social media by storm.

A glasses-wearing kitty?: Getting to know Truffles

Artificial intelligence (AI) is finding its niche in medical research, with more and more applications being explored. A team of researchers in the United Kingdom (UK) are exploring AI to simplify appropriate patient recruitment in trials focused on geographic atrophy (GA) associated with age-related macular degeneration (AMD).

First authors and PhD candidates Dominic J. Williamson and Robbert R. Struyven point out that developing new treatments is expensive, can take decades, and relies heavily on data from clinical trials to demonstrate the safety and efficacy of the new treatments. “Today, challenges in recruiting participants stand as a significant obstacle in clinical trials.Time taken to fully recruit a trial adds significantly to the cost and can lead to delays, with up to 86% of trials not finishing on schedule,”

 the researchers write. Williamson and Struyven are from the National Institute for Health and Care Research Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital National Health Service Foundation Trust in London, UK, and the Centre for Medical Imaging Computing at University College London.

In light of this, Williamson, Struyven, and their colleagues conducted a cross-sectional study to explore the role of AI in clinical trial recruitment of individuals with GA. The investigators used a retrospective data set from the INSIGHT Health Data Research Hub for Eye Health at Moorfields Eye Hospital that included 306,651 patients (602,826 eyes) with suspected retinal disease who underwent optical coherence tomography (OCT) imaging between January 1, 2008, and April 10, 2023.

The investigators recount that they trained a deep learning model on OCT scans to identify patients potentially eligible for GA trials using AI-generated segmentations of retinal tissue. This method was compared with a keyword-based electronic health record (EHR) search for accuracy. They also carried out clinical validation with fundus autofluorescence (FAF) images to calculate the positive predictive value (PPV) of this approach by comparing AI predictions with expert assessments.

The main outcome measure was the PPV of AI for identifying trial-eligible patients. The secondary outcome was the intraclass correlation between the GA areas segmented on FAF by experts and AI-segmented OCT scans.

The authors report, “The AI system shortlisted a larger number of eligible patients with greater precision (1139[;] PPV, 63%; 95% CI, 54%-71%) compared [with] the electronic health records search (693[;] PPV, 40%; 95% CI, 39%-42%).” When AI and the EHR approach were combined, a total of 604 eligible patients with a PPV of 86% (95% CI, 79%-92%) were identified.

The intraclass correlation of GA area segmented on FAF vs AI-segmented area on OCT was 0.77 (95% CI, 0.68-0.84) for eligible cases. The AI also adjusts to the distinct imaging criteria from several clinical trials, generating tailored shortlists ranging from 438 to 1817 patients, the investigators report.

The investigators conclude that AI has the potential to streamline the clinical trial process, first by identifying patients with greater ease and later in other stages of the clinical trial process. The investigators write, “We demonstrated that an AI tool can facilitate clinical trial recruitment in AMD. Given the intense clinical trial activity currently underway, we believe that implementing this AI-driven strategy will offer a scalable solution to the recruitment challenges in
GA trials. Our future efforts will concentrate on assessing the real-world robustness of this AI solution, ensuring it performs well with routinely collected images of varying quality, protocols, [and] equipment and across diverse populations.”

They also believe that, in addition to prescreening patients, AI may enable site feasibility assessments, data-driven protocol design, and cost reduction. Once treatments are available, similar AI systems could also be used to identify individuals who may benefit from treatment, they hypothesize.

Both Williamson and Struyven are from the National Institute for Health and Care Research Biomedical Research Centre for Ophthalmology at Moorfields Eye Hospital National Health Service Foundation Trust in London, United Kingdom, and the Centre for Medical Imaging Computing at University College London. They have no financial interest in this subject matter.

1. Williamson DJ, Struyven RR, Antaki F, et al. Artificial intelligence to facilitate clinical trial recruitment in age-related macular degeneration. 

. Published online June 19, 2024. doi:10.1016/j.xops.2024.100566

2. Parke DW II. RCTs: the gold standard’s future. American Academy of Ophthalmology. February 1, 2019. Accessed July 8, 2024. https://www.aao.org/eyenet/article/rcts-the-gold-standards-future

3. Treweek S, Lockhart P, Pitkethly M, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. 

2013;3(2):e002360. doi:10.1136/bmjopen-2012-002360

4. Sertkaya A, Birkenbach A, Berlind A, Eyraud J; Eastern Research Group Inc. 

Examination of Clinical Trial Costs and Barriers for Drug Development

. US Department of Health and Human Services. July 24, 2014. Accessed July 8, 2024. https://aspe.hhs.gov/reports/examination-clinical-trial-costs-barriers-drug-development-0

5. Huang GD, Bull J, Johnston McKee K, Mahon E, Harper B, Roberts JN; CTTI Recruitment Project Team. Clinical trials recruitment planning: a proposed framework from the Clinical Trials Transformation Initiative. 

 2018;66:74-79. doi:10.1016/j.cct.2018.01.003

Utilizing artificial intelligence may provide feasibility assessments, data-driven protocol design, and cost reduction opportunities.

Coupling of clinical trial recruitment and AI eases the burden of GA studies

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

This quiz accompanies THIS article from our December issue

c. One-third eye width, canthus to canthus

d. One-third eye fissure opening vertically

Quiz: Know the ocular effects of eyelash growth serums

A team of international investigators has found that color vision deficiency (CVD) may interfere with an eye care provider’s ability to differentiate between choroidal melanoma and choroidal nevus.

Yacoub A. Yousef, MD, is the first study author and an ocular oncologist in the Department of Surgery (Ophthalmology), King Hussein Cancer Center, Amman, Jordan.

Color blindness is not an uncommon phenomenon, and reportedly 8% of men and 0.4% of women are affected; the incidence in men is higher because of the disorder’s X-linked recessive inheritance.

 Deuteranopia (red-green deficiency) is the most common form; however, total color blindness is rare.

Yousef and the investigators explained that while CVD often is overlooked, it “poses unique challenges in ophthalmology, where accurate color perception is pivotal for clinical examination and imaging interpretation.”

A few studies have highlighted the differences between health care professionals with CVD and those with normal color vision, indicating potential challenges in interpreting clinical images, leading to delayed referrals and treatment and increased morbidity and mortality rates for patients.

The investigators conducted a cross-sectional study to determine how CVD
affects physicians’ diagnostic accuracy and their ability to distinguish between
malignant choroidal melanoma and benign choroidal nevus.

They distributed a web-based survey using the professional Ophthalmology Society’s social media channels. The survey presented 3 fundus images representing a normal fundus, choroidal nevus, and choroidal melanoma. They explained that the images underwent simulation for the 3 primary types of CVD—protanopia (red color blindness), deuteranopia, and tritanopia (blue-yellow deficiency)—and were presented alongside nonsimulated versions.

Yousef's team noted a total of 41 participants were included in the study (average age, 40 years; 28 men, 13 women). Based on the results of the online Ishihara Test, the participants were confirmed to not have CVD.

The authors reported that the participants had significantly lower rates of identifying orange pigments in the simulated protanopia images compared with in the nonsimulated images (

 = .038). The participants’ ability to recognize melanotic lesions in the simulated deuteranopia images was reduced compared with in the nonsimulated images (

 = .048); however, this was not the case for tritanopia.

The participants were able to identify subretinal fluid and estimate tumor thickness in the simulated and nonsimulated images.

“Regarding the simulated images of choroidal nevi, the participants misdiagnosed nevi as choroidal melanoma in 37% of cases in simulated protanopia nevi images and 41% in simulated deuteranopia nevi images,” Yousef and colleagues wrote. “This resulted in unnecessary referrals of benign lesions as malignant, emphasizing the potential for mistaken diagnoses. Nevertheless, almost all simulated images of malignant melanoma were correctly referred for specialized oncological treatment.”

In commenting on their findings, Yousef and the investigators pointed out that CVD may impact an ophthalmologist’s ability to differentiate between choroidal melanoma and choroidal nevus. The simulated CVD conditions of protanopia and deuteranopia affected the accuracy when identifying the melanotic nature of the lesion and orange pigments, which led to challenges in correctly diagnosing choroidal melanoma and choroidal nevus, resulting in extra referrals for nevus cases.

Importantly, they noted “the possible risk of eyes with choroidal melanoma could still be determined, so most melanoma cases were referred to specialized oncologists as needed. Further investigations are needed to assess the clinical significance of these findings in individuals with CVD.”

Yousef YA, Alkhatib F, Elfalah M, et al. Assessing the impact of simulated color vision deficiency on ophthalmologists’ ability to differentiate between choroidal melanoma and choroidal nevus. 

. 2024;13(12):3626. doi:10.3390/jcm13123626

Campbell JL, Spalding AJ, Mir FA, Birch J. Doctors and the assessment of clinical photographs—does colour blindness matter? 

Balasundaram R, Reddy SC. Prevalence of colour vision deficiency among medical students and health personnel. 

Elfalah M, AlRyalat SA, Abu-Yaghi NE, et al. The impact of color vision deficiency on the capability of ophthalmologists to diagnose benign and malignant choroidal tumors. 

CVD could impact physicians' ability to identify choroidal melanoma from choroidal nevus.

Researchers find color vision deficiency may impact choroidal diagnosis

Bausch + Lomb has now launched Opal, a digital e-commerce marketplace designed to maximize efficiencies for eye care practices that is also available to their patients, in the US.

 The marketplace will streamline the ordering process for Bausch + Lomb contacts lenses, with other select OTC products to be added in the coming months, according to a news release.

“Opal is an all-in-one digital platform that offers faster, more convenient ordering of Bausch + Lomb products, helping to save staff time, boost patient loyalty and reduce the administrative burden for participating eye care practices,” said Yang Yang, president of Global Vision Care, Bausch + Lomb in the release. “This platform is the latest example of our continued focus on meeting the evolving needs of eye care professionals and their patients.”

Opal features order tracking and history, appointment reminders, and automated prescription reminders. The orders made through the marketplace are then delivered with free shipping directly to either patients’ homes or eye care practices. Additionally, each purchase made by a patient earns points toward the Baush + Lomb Horizon Rewards loyalty program.

“Opal simplifies administrative tasks such as order processing, inventory management and cost comparisons, to help free up resources and valuable staff time,” said Jason Tu, OD, of Vision Boutique in San Diego; past president of the California Optometric Association; and an Opal beta tester; in the release. “With such a user-friendly interface, Opal allows my patients to order their Bausch + Lomb products directly from my practice, whether they’re in the office or elsewhere. This not only enhances convenience for my patients but also supports the growth of my business. As a private practice owner, creating efficiencies in my back-office processes is crucial, and Opal significantly contributes to that.”

Select Bausch + Lomb products, including contact lenses like INFUSE, ULTRA, and Biotrue ONEday, are available through Opal can be found through a customizable catalog. OTC products available through Opal will include LUMIFY redness reliever eye drops and Blink eye drops.

Bausch + Lomb launches Opal digital marketplace in the United States. Bausch + Lomb. October 1, 2024. Accessed October 1, 2024. 

Opal, the new digital marketplace, will streamline contact lens ordering and allow patients and practices to order select OTC products, according to a news release.

Bausch + Lomb launches digital marketplace for eye care practices and patients in US

A new clinical study evaluating long-term myopia control effect and user experience in patients wearing Defocus Incorporated Multiple Segments (DIMS)-outfitted MiYOSMART spectacle lenses found that a significant amount of said patients continued to wear the lenses for as long as 8 years. Findings from the 8-year follow-up clinical study were presented by HOYA Vision Care at the 60th International Myopia Conference 2024 in Sanya, China, according to a news release.

“With myopia on the rise, it is important for eye care professionals to choose treatments to slow the progression in children based on best evidence available,” said Carly Lam, PhD, principal investigator of the study, in the release. “Previous research has shown that the DIMS spectacle lenses appear to be a safe and effective method for managing myopia among the study population. We’re looking forward to seeing the impact of longer-term use on myopia management in this pediatric population.”

According to HOYA, the randomized, controlled trial is the longest of its kind conducted and presented on the MiYOSMART lenses. Of study participants, 60% who wore the DIMS spectacles for 6 years continued to wear the lenses for as long as 8 years.

 All participants were satisfied with the benefits from the DIMS lenses, according to the release.

DIMS technology has a ring-shaped treatment area to slow myopia progression. By alternating the focus area—or the clear zone of the lens—and defocus area—the honeycomb-shaped segment of the lens—clear vision and management of myopia is obtained.

The lens has also been found to remain consistent on the myopia management front in a different study over 6 years.

“Childhood myopia is a widespread concern, and we are committed to continue fighting this problem, by using innovative solutions like MiYOSMART spectacle lenses. We look forward to the data from this important study as we continue to work to slow the progression of myopia in children and preserve their vision and eye health for the future,” said Natalia Vlasak, MD, MBA, global head of Medical and Scientific Affairs at HOYA Vision Care, in the release.

The MiYOSMART spectacle lenses have not been approved for use in the management of myopia and is currently not on the market in the US. However, HOYA has sold more than 8 million MiYOSMART spectacle lenses in more than 35 countries and regions.

HOYA Vision Care announces the results of the longest follow-up study conducted and presented on myopia management spectacle lenses worldwide. News release. HOYA Vision Care. September 27, 2024. Accessed September 30, 2024.

MiYOSMART. HOYA Vision Care. Accessed September 30, 2024. https://www.hoyavision.com/for-spectacle-wearers/miyosmart/ 

By alternating the focus area—or the clear zone of the lens—and defocus area—the honeycomb-shaped segment of the lens—the spectacle lenses achieve clear vision and manage myopia progression.

Danielle Crull

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