David Hutton

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Dry eye disease (DED) continues to be a difficult problem for patients whose eyes do not provide adequate lubrication. The discomfort that results from dry eyes may affect vision, and if left untreated, the National Eye Institute (NEI), noted that it can damage the cornea.

Prevent Blindness has declared July as “Dry Eye Awareness Month” to provide free resources to providers and the public on dry eye, including fact sheets and shareable social media graphics in both English and Spanish, and a dedicated webpage.

Additionally, as part of the Focus on Eye Health Expert Series, Stephanie Marioneaux, MD, cornea and external disease specialist, and Prevent Blindness board of directors member, provides detailed information in the recent “

Mental health may also be affected by dry eye. A 

recent study published in JAMA Ophthalmology

 found that depression was associated with more severe dry eye symptoms and overall signs, suggesting that among patients with moderate to severe DED, those with depression may be likely to have more severe DED. According to the study conclusion, the findings support consideration of depression as a comorbidity when managing patients with DED.

Extreme sensitivity, especially to cigarette smoke

Having these symptoms may mean that you have dry eye, but they may also be caused by other conditions. A thorough evaluation by an eye doctor is needed to determine the exact cause of these vision symptoms.

“Dry eye can have lasting, damaging effects if left untreated,” said Jeff Todd, president and CEO of Prevent Blindness. “An exam by an eyecare professional can equip patients with a treatment plan that protects vision and improves mental health.”

For more information on dry eye, please visit the Prevent Blindness resource page at 

preventblindness.org/understanding-dry-eye

Articles

The organization hopes to increase awareness and education of a condition that affects vision, mental health. 

Prevent Blindness: July is Dry Eye Awareness Month

Notal Vision Inc. reported this week that several scientific and clinical presentations prove the feasibility and efficacy of their patient-operated, home-based optical coherence tomography (OCT) device.

According to the company, as part of a remote monitoring service, which includes a monitoring center and artificial intelligence algorithms for information processing, the OCT device (Notal Home OCT) monitors wet age-related macular degeneration (AMD) treatment between doctor’s office visits.

Wet AMD is the leading cause of blindness in people older than the age of 50 in the United States. Several treatments have been developed over the last 2 decades and have proven to be extremely beneficial. However, therapy requires frequent office visits for disease monitoring, placing a major burden on physicians, patients, and their caregivers. This burden has contributed to the limited real-world efficacy of these treatments.

The company noted that home monitoring using standard of care OCT technology is expected to optimize treatment regimens for these patients and provide better vision outcomes. The key challenges for home OCT technology include demonstrated correlation with in-office devices, full self-operation by the patients, convenient use in a home setting, continuous patient compliance, and the ability to extract meaningful information from the high-volume data being generated. The investigational OCT device, which received an FDA breakthrough designation, is a pipeline technology for monitoring wet AMD treatments.

A series of studies using the investigational OCT device have shown that the device is effective in overcoming each of these challenges. A prospective and cross-sectional study,

 which included 333 wet AMD patients and 600 eyes, demonstrated the ability of patients to self-image in a clinic setting, with over 91% of patients being able to successfully acquire images without technician assistance. The imaging showed excellent correlation with in-office OCT for detecting the presence of fluid, an important biomarker in wet AMD, with over 95% agreement.

“We were very surprised by Home OCT’s self-imaging success rate and the patient response,” said David Lally, MD, from the Retina Research Institute at New England Retina Consultants, Springfield, Massachusetts. “Patients with limited vision were able to self-image with no assistance, and most patients felt that use of the device was much easier than they initially anticipated. I think after imaging nearly 600 eyes with Home OCT, we can be confident in its capability to produce reliable images with patient self-operation.”

The company also noted in its release that a prospective and longitudinal study to understand patients’ ability to self-image in a home setting with no prior training was conducted by prominent retina specialists Jeffrey Heier, MD and Nancy Holekamp, MD.

According to the release, the program enrolled 15 wet AMD patients and the device was shipped to their homes by the Notal Vision Monitoring Center. Subjects were able to set up the device themselves and perform daily scans with the support of the Monitoring Center clinical staff.

Patients demonstrated extraordinary self-imaging capability, with a total of 2300 scans taken at a 95% success rate. Yingna Lui, MD recently presented the results from this study at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, which also demonstrated the importance of home-based OCT data for better disease management in patients, reviewing specific remote monitoring case studies. The US study followed a prospective longitudinal pilot study conducted in Israel by Anat Loewenstein, MD and colleagues in 2020.

The release also noted that patient compliance was also studied in the Heier and Holekamp longitudinal study. Patients performed an average of 5.8 exams per week, demonstrating strong compliance to ensure any exudation of fluid, critical to wet AMD management, was promptly captured. Patients were asked to assess their satisfaction of the OCT device as part of the study and rated it neutral to highly satisfactory on over 95% of questions, and highly agreed on convenience and ease of use.

“The Notal Vision Monitoring Center shipped the device directly to patients and managed all their training and patient questions­ ­– no training was provided by our site,” said Heier, director of the retinal service and retinal research at Ophthalmic Consultants of Boston. “Physicians reviewed the AI-generated data from the device using a web-based viewer. This technology has the potential to allow clinicians daily assessment of fluid status, earlier recognition of recurrent activity, and can reduce the significant burden currently placed on patients, caregivers, and their providers.”

Home OCT cannot be adopted by doctors without the ability to distill the large volumes of images generated by the device into actionable information. This process is managed by the AI-powered Notal OCT Analyzer (NOA). Fluid regions captured by Home OCT’s B-scans are segmented and quantified by NOA and these volumes, an important biomarker in wet AMD, are studied over time. NOA’s performance was demonstrated by Michael Elman, MD and Sid Schechet, MD during a 26-patient study they conducted, in which patient self-acquired scans were analyzed using NOA and compared with expert-graded commercial OCT scans. Presented by Dr. Elman at the ARVO annual meeting, the results found a high correlation of over 97% between the NOA and manually graded OCT scans. This study further demonstrates the capability of the AI-based algorithm for fluid quantification in wet AMD patients.

“We are excited to see multiple investigators evaluating different aspects of our investigational Home OCT platform,” said Kester Nahen, PhD, CEO of Notal Vision. “This is further validation of the efficacy of our digital health-based remote monitoring model, which we currently use for the ForeseeHome AMD Monitoring Program. We believe we have perfected the various components of the model over the past ten years, which has greatly helped us bring this impactful technology closer to market.”

Notal Vision’s home-based OCT pipeline technology has received an FDA Breakthrough Device designation and is in the process of obtaining FDA clearance. In January 2020, the American Medical Association established three category III Current Procedural Terminology (CPT) codes for reporting patient-initiated remote retinal OCT scans, facilitated by Notal Vision’s home-based OCT.

The physician review, interpretation and documentation of AI-based analyses will be billable every 30 days.

Kim JE, Tomkins-Netzer O, Elman MJ, Lally DR, 

 Evaluation of a self-imaging SD-OCT system designed for remote home monitoring. 

https://doi.org/10.1186/s12886-022-02458-z

Liu Y, Holekamp NM, Heier JS. Prospective, Longitudinal Study: Daily Self-Imaging with Home OCT for Neovascular Age-Related Macular Degeneration. 

https://doi.org/10.1016/j.oret.2022.02.011

Keenan TDL, Goldstein M, Goldenberg D, Zur D, Shulman S, Loewenstein A, Prospective, Longitudinal Pilot Study Daily Self-Imaging with Patient-Operated Home OCT in Neovascular Age-Related Macular Degeneration. 

https://doi.org/10.1016/j.xops.2021.100034

Investigators show the effectiveness of Home-OCT based remote monitoring model. 

Efficacy of Notal Vision OCT device demonstrated by a series of scientific and clinical work

The American Society of Cataract and Refractive Surgery (ASRCS) and American Academy of Ophthalmology (AAO) have spearheaded a year-long effort to remove the policy that the insurance company had in place requiringpreauthorization for cataract surgery.

ASCRS announced Frida that as a direct result of its advocacy, with collaboration from the AAO and the grassroots efforts of our members, Aetna is dropping the policy.

Aetna will no longer require prior authorization for cataract surgery, except for Medicare Advantage (MA) beneficiaries in Florida and Georgia as of July 1, 2022.

“As president of ASCRS, I'm thrilled about the work that was done over the past year by ASCRS and AAO that led to Aetna dropping its prior authorization policy for cataract surgery. As Richard Hoffman, MD, said last year, 'the best two people qualified to determine if cataract surgery is necessary are the patient and their ophthalmologist.' I could not agree more and am pleased that right has been restored,” ASCRS President Douglas Rhee, MD, said in a statement. “I'd like to personally thank the members of the ASCRS Government Relations Committee, ASCRS Government Relations staff, and the members who personally reached out to Aetna for their tireless efforts advocating to maintain access to vision-restoring care for our patients.”

According to the news release, Aetna’s decision to require prior authorization of all cataract surgery procedures went into effect on July 1, 2021. This policy created overly burdensome amounts of work for ophthalmic practices, resulting in tens of thousands of delayed cataract surgeries and even denials for some patients when the procedure was medically necessary.

Since the beginning, hundreds of ASCRS and ASOA members flooded Aetna leadership with personal stories, detailing the harmful impact of this policy on patients and their practices. ASCRS and AAO engaged in a joint public relations campaign with Schmidt Public Affairs that ultimately resulted in 200 targeted media placements inside the beltway and in media markets nationwide that helped educate the public about the negative impact this policy had on physicians, as well as the dangers of delayed and denied care for Aetna beneficiaries.

In addition, ASCRS and AAO held several meetings with Aetna leadership, questioning the policy’s necessity, detailing the difficulties with rollout and issues with compliance.

ASCRS also engaged with policymakers on the issue. ASCRS Government Relations Chair Parag Parekh, MD, participated in a roundtable discussion with CMS, detailing our concerns with Aetna's prior authorization policy for cataract surgery and various issues with its implementation. Representative Mariannette Miller-Meeks, MD, R-Iowa, and Senator Rand Paul, MD, R-Kentucky, both ophthalmologists, joined ASCRS in expressing concerns over this policy in letters sent to CMS.

. CMS, following letters from these lawmakers, sent a formal letter to Aetna, outlining concerns about the program.

“Almost a year to the day, I spoke about how I was sad and angry to have to cancel cases that were arranged months ago, delaying patient care, due to this poorly reasoned prior authorization policy,” Parekh said in a statement. “For the past year, it has been a challenge to grapple with this requirement when I saw patients needing cataract surgery, but the insurer ultimately decided on medical necessity. It has also been a burden from a practice management standpoint. I am glad to again have the authority, as the surgeon, to determine what is best for my patients and when.”

ASCRS continued, even in recent months, to hold meetings with CMS, expressing concerns of how management tools, like prior authorization, can be abused by insurers, and more specifically how Aetna’s policy continued to delay patients’ access to cataract surgery, putting them at risk for accidents due to depth perception issues.

“For the past year, ASCRS has been advocating, on behalf of its member surgeons, cataract patients, and the ophthalmic community as a whole, for Aetna to put a stop to its prior authorization requirement that delayed sight-restoring surgery and put patients at risk,” ASCRS Executive Director Steve Speares said. “We feel gratified that these efforts paid off and that Aetna has rescinded this policy in most states.”

In a statement, Stephen D. McLeod, MD, AAO’s CEO, noted that Aetna’s decision to impose the pre-approval for cataract surgeries proved to be difficult to decipher with reasons for surgery firmly established and the ultimate benefits clear.

“And the immediate impact on patients subject to unnecessary delay should have been obvious: this is an incredibly common procedure with some 4 million Americans undergoing cataract surgery each year,” he said in the AAO news release. “It has an extremely high success rate with regard to safety and vision improvement, and studies have consistently shown that cataract surgery improves quality of life, lowers the risk of falls and car accidents, and is associated with reduced cognitive decline amongst older adults.”

ASCRS, AAO behind year-long drive for policy change, with Aetna dropping its requirement on July 1 for pre-authorization for cataract surgery, covering patients in 48 of 50 states. 

Aetna drops policy requiring prior authorization for cataract surgery in 48 states 

Graphic showing the ten-year follow up of visual functions in 32 children who in the first year following their birth experienced Grade 3 or Grade 4 Intraventricular hemorrhage with Ventricular dilatation (IVHVD). (Image courtesy of University of Bristol)

Severe “brain bleeds” experienced by some babies in the first year following their birth lead to long-term sight problems, researchers at the University of Bristol have found as part of a 10-year follow-up study.

, reviewed 32 children who had detailed assessments at 10- to 11-years-old after experiencing Grades 3 or 4 intraventricular hemorrhage (brain bleeds) and ventricular dilation (IVHVD) as part of a study called DRIFT10.

According to a news release from the University of Bristol, the DRIFT10 study was set up to investigate a ‘brain washing’ technique for brain bleeds called DRIFT (Drainage, Irrigation and Fibrinolytic Therapy). DRIFT, pioneered by Bristol researchers, is the first and only treatment to objectively benefit infants with serious brain hemorrhage by washing out the ventricles in the brain to remove toxic fluid and reduce pressure.

The research team reviewed 32 children aged 10- to 11-years-old. They investigated whether the Grade of IVHVD experienced as babies affected their visual outcome at the end of their primary school years and explored associations between visual outcomes with cognitive outcomes and with extra support at school.

The visual examinations were part of a ten-year follow-up study for children in the original DRIFT randomized trial. Testers followed a protocol, and it was unknown to them whether the child had experienced Grade 3 or Grade 4 IVHVD and all other data.

The study found all 32 children assessed had at least one visual impairment. The average number of impairments per child was six for children who experienced a Grade 4 IVHVD compared to three for children who experienced a Grade 3 IVHVD. Each extra vision impairment for each child was associated with increased educational support at school, after adjustment for developmental age equivalence.

These sight problems affecting the children ten years later were often due to damage to the visual areas in the brain. These included problems with moving the eyes accurately, with detecting objects in the space around them or with visually matching shapes or orientations of lines.

The children's parents were unaware of these problems and mostly reported their children had normal vision as long as any glasses they had were being worn.

However, the researchers found that for each additional sight problem a child had, they were more likely to be getting extra support with their learning. This suggests the sight problems may have contributed to the difficulties with learning experienced by this group of children.

, the study’s lead author and Professor of Pediatric Ophthalmology at 

Bristol Medical School: Population Health Sciences

 and Consultant Pediatric Ophthalmologist at 

University Hospitals Bristol and Weston NHS Foundation Trust

 (UHBW), explained that the research suggests that all children who experience brain bleeds or similar problems as babies should have eye tests to identify brain-related vision problems as they grow up, so that appropriate support can be offered to see if it is helpful for them. 

“Researchers in the future should be aware that parents who report normal vision may miss sight problems that are important for their children's learning and development,” she concluded.

Researchers at the University of Bristol, as part of a 10-year follow-up study, found that severe  “brain bleeds” experienced by some babies in the first year following their birth lead to long-term sight problems.

HEAD: Study: “Brain bleeds” in babies’ first year can lead to long-term sight problems

AI for the eye. The developed lightweight model precisely and rapidly detects image abnormalities related to diseases of the eye. The model is expected to provide accurate analysis on mobile devices/low CPU-GPU resource single board computers used in standalone self-monitoring devices. (Image courtesy of Parmanand Sharma, PhD)

A new deep learning (DL) model that can identify disease-related features from images of eyes has been unveiled by a group of investigators from Tohoku University in Sendai, Japan.

According to the university, this 'lightweight' DL model can be trained with a small number of images, even ones with a high-degree of noise, and is resource-efficient, meaning it is deployable on mobile devices.

With many societies aging and limited medical personnel, DL model reliant self-monitory and tele-screening of diseases are becoming more routine. Yet, deep learning algorithms are generally task specific, and identify or detect general objects such as humans, animals, or road signs.

Identifying diseases, on the other hand, demands precise measurement of tumors, tissue volume, or other sorts of abnormalities. To do so requires a model to look at separate images and mark boundaries in a process known as segmentation. But accurate prediction takes greater computational output, rendering them difficult to deploy on mobile devices.

"There is always a trade-off between accuracy, speed and computational resources when it comes to DL models," noted Toru Nakazawa, MD, PhD, co-author of the study and professor at Tohoku University's Department of Ophthalmology. "Our developed model has better segmentation accuracy and enhanced model training reproducibility, even with fewer parameters - making it efficient and more lightweight when compared to other commercial softwares."

Nakazawa, Parmanand Sharma, PhD, Takahiro Ninomiya, MD, and students from the Department of Ophthalmology worked with professor Takayuki Okatani, PhD, from Tohoku University's Graduate School of Information Sciences to produce the model.

According to the university, using low resource devices, the investigators obtained measurements of the foveal avascular zone, a region with the fovea centralis at the center of the retina, to enhance screening for glaucoma.

"Our model is also capable of detecting/segmenting optic discs and hemorrhages in fundus images with high precision," Nakazawa explained.

In the future, the group is hopeful of deploying the lightweight model to screen for other common eye disorders and other diseases.

 A lightweight deep learning model for automatic segmentation and analysis of ophthalmic images. 

 8508 (2022). https://doi.org/10.1038/s41598-022-12486-w

A new deep learning  model that can identify disease-related features from images of eyes has been unveiled by a group of investigators from Tohoku University. 

New deep learning model helps the automated screening of common eye disorders

Artistic rendering of choroidal neovascularization: new, damaging blood vessels (highlighted in red) growing from beneath and into the retina of a mouse. This blood vessel growth is typical of patients with wet age-related macular degeneration. Blue highlights the nuclei of cells. Green and yellow highlight expression of ANGPTL4. (Image courtesy of Alexander Sodhi McDonogh School)

In a study of eye fluid from 38 patients, Johns Hopkins Medicine researchers say they have found that levels of a specific protein appears to help accurately predict whether people with the wet form of age-related macular degeneration may need lifelong, frequent eye injections to preserve vision or if they can be safely weaned off the treatments.

In a news release from Johns Hopkins Medicine, the researchers explain that the protein could also be targeted by new therapies to halt vision loss among patients with the disorder, caused by abnormal growth of blood vessels that leak fluid or bleed into the portion of the retina needed for central vision.

The researchers’ findings were published online June 2.

Overall, age-related macular degeneration is the most common cause of vision loss among people age 50 and older, affecting an estimated 7.3 million individuals in the United States.

According to the Johns Hopkins news release, the standard treatment of wet age-related macular degeneration requires monthly or twice-monthly eye injections of so-called anti-VEGF drugs that slow or stop the growth of leaky blood vessels and, in most cases, stave off further vision loss.

Because the injections are inconvenient, costly, uncomfortable, and carry risk of infection, retinal detachment and other side effects.

Standard treatment of wet age-related macular degeneration requires monthly or twice-monthly eye injections of so-called anti-VEGF drugs that slow or stop the growth of leaky blood vessels and, in most cases, stave off further vision loss.

Because the injections are inconvenient, costly, uncomfortable, and carry risk of infection, retinal detachment and other side effects,

“The proteins in the eye may help us identify patients who can safely be weaned off these therapies or transition to other, new ways of delivering these drugs to the retina, Akrit Sodhi, MD, PhD, associate professor of ophthalmology and the Branna and Irving Sisenwein Professor in Ophthalmology at the Wilmer Eye Institute at the Johns Hopkins University School of Medicne said in the news release.

Sodhi’s research team has long been studying ways to identify subgroups of patients who can safely reduce – or even cease – eye injection therapies without further vision loss.

According to the news release, in the current study, Sodhi’s team investigated whether measurable levels of certain proteins in the eye could be used as predictors, known as biomarkers, of disease stabilization or progression despite treatment.

As part of the project, researchers collected samples of eye fluid from 38 patients at the beginning of their treatment for macular degeneration at the Wilmer Eye Institute between 2013 and 2020 in two Maryland locations. These patients were then grouped based on the frequency with which they required treatment at the end of 1 year.

The researchers then screened the samples of each of these groups for proteins linked to the development of abnormal blood vessels. Among the proteins present, the researchers found that one, named angiopoietin-like 4, was present at higher levels in patients who required monthly treatment when compared with patients who were eventually able to reduce the frequency of injections or even stop treatment without further vision loss.

Using statistical models, Sodhi’s team found that relatively higher levels of angiopoietin-like 4 (higher than 4.22 ng/mL) accurately predicted actual clinical outcomes in the patient population, identifying with 91% sensitivity those patients who would continue to require monthly eye injections to preserve their vision.

However, the news release noted that researchers found that measuring only angiopoietin-like 4 led to many false-positives, with one third of the patients flagged by the test not requiring monthly therapy.

In a bid to improve the accuracy of the prediction model, they paired measurements of angiopoietin-like 4 with VEGF, the protein specifically targeted by current wet macular degeneration treatments. With both of these proteins, the researchers were able to correctly identify with 76% sensitivity and 85% specificity patients who likely need monthly eye injections; this group of wet macular degeneration patients could benefit from newer longer acting anti-VEGF therapies.

In animal experiments, the researchers next examined whether blocking angiopoietin-like 4 in the eye could be a potential therapeutic approach for wet age-related macular degeneration.

The researchers used nanoparticles developed in collaboration with 

, Professor of Biomedical Engineering at the Johns Hopkins University School of Medicine, to deliver RNA interference (RNAi) designed to target the expression of either angiopoietin-like 4 or VEGF in the retina in mice with eye lesions similar those in patients with wet age-related macular degeneration.

Mice that received either the angiopoietin-like 4-blocking RNAi treatment or the VEGF-blocking RNAi treatment, both had lower levels of abnormal blood vessel growth than mice which received control treatment. However, in mice that received RNAi targeting both VEGF and angiopoietin-like 4, the treatment showed an additive effect, with even lower abnormal blood vessel growth than RNAi targeting either protein alone.

As an alternative to using RNAi as a therapy, the researchers tested a naturally-found protein called soluble neuropilin, 

which the researchers have previously shown have a quenching effect on VEGF and angiopoietin-like 4 in studies in diabetes.

 The researchers tested soluble neuropilin by injecting the protein into the eyes of mice. The test yielded similar results as the RNAi, effectively treating the growth of the abnormal blood vessels, revealing that targeting both angiopoietin-like 4 and VEGF together leads to effective relief of wet age-related macular degeneration lesions.

Collectively, these experiments provide the foundation for studies examining therapies targeting both VEGF and ANGPTL4, and help explain why elevated levels of these two proteins in the eyes of patients predicts how patients respond to current therapies targeting only VEGF.

“Angiopoietin-like 4 and VEGF act synergistically to create more severe choroidal neovascular lesions in the eye. They could, potentially, be used as both a biomarker as well as a treatment target,” says Sodhi.

Other researchers who contributed to this study include Xuan Cao, Jaron Castillo Sanchez, Kathleen Jee, Murilo Rodrigues, Chuanyu Guo, Jordan Vancel, Deepak Menon, Noore-Sabah Khan, Stephany Tzeng, Yassine Daoud, Jordan Green and Gregg Semenza of Johns Hopkins; Yu Qin of the Johns Hopkins University School of Medicine and the Fourth Affiliated Hospital of China Medical University; Aumreetam Dinabandhu of the Johns Hopkins University School of Medicine and the University of Maryland; Jing Zhang of the Johns Hopkins University School of Medicine and Sun Yat-Sen University, Guangzhou, China; and Tao Ma and Silvia Montaner of the University of Maryland.

This work was supported by the National Eye Institute (R01EY029750, R01EY025705, R01EY031097, EY001765), the Research to Prevent Blindness, Inc. Special Scholar Award, the Sybil B. Harrington Stein Innovation Award, the Alcon Research Institute, and the Branna and Irving Sisenwein Professorship in Ophthalmology.

Yu Qin, Aumreetam Dinabandhu, Xuan Cao, Jaron C. Sanchez, Kathleen Jee, Murilo Rodrigues, Chuanyu Guo, Jing Zhang, et al; ANGPTL4 influences the therapeutic response of neovascular age-related macular degeneration patients by promoting choroidal neovascularization. JCI Insight; published June 2, 2022; doi: 10.1172/jci.insight.157896

A team of investigators form Johns Hopkins Medicine say they’ve discovered that levels of a specific protein appears to help accurately predict whether people with the wet form of age-related macular degeneration may need lifelong, frequent eye injections to preserve vision or if they can be safely weaned off the treatments.