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Excerpt

Primary Care: The Front Line of Detecting Diabetic Retinopathy

Over the last decade, an unmistakable shift has taken root in the detection of diabetic retinopathy. Once considered a pillar of the general wellness exam, the practice of using the direct ophthalmoscope for fundus examination is rapidly declining. Also, the primary care office is poised to become the new frontline of detecting eye-related problems. Doing vision screenings in the primary care office can overcome many of the barriers that interfere with timely treatment. This sets up diabetic patients for a significantly improved prognosis as it relates to vision-threatening diabetic retinopathy.

The Golden Age of Ophthalmology

The so-called golden age of ophthalmology was triggered by the invention of the direct ophthalmoscope in 1851 and lasted until the late 1800s. In-vivo observation of the ocular fundus was incredibly impactful on diagnosing ocular and neurological conditions of the day. With this practice, ophthalmoscopy promptly established itself as an integral part of the general physical examination.

After the advent of the handheld direct ophthalmoscope in 1915, it was common to find one in every general practitioner’s pocket. They were compact, affordable, and effective at diagnosing an array of ocular and neurological conditions, especially compared to other technology of the time. Ophthalmology grew to become a staple of the medical school curriculum.

The Decline of Direct Ophthalmology

Over the past four decades, there has been a continuous decline in ophthalmologic material in the medical school curriculum. Concurrently, there is disagreement among authorities over what degree of proficiency should be expected of medical students when using a direct ophthalmoscope and over recognition that the learning curve for this skill is steep. During this same period, multitudinous studies have discussed that modern physicians are losing confidence in their self-perceived skills of fundus examination using a direct ophthalmoscope. Furthermore, there is evidence that the direct ophthalmoscope is missing referrable cases of diabetic retinopathy, even by ophthalmologists.

A 2015 article in Eye, the scientific journal of the Royal College of Ophthalmologists, presents the case that direct ophthalmoscopy should cease to be taught to modern medical students. The authors suggest that medical schools should opt instead to use their ophthalmologic hours to teach tomorrow’s doctors to interpret fundus imaging captured by fundus cameras. The authors argue that fundus photography is easy to learn and effective for capturing good-quality images. They provide evidence that the direct ophthalmoscope is difficult to use and too frequently leads to missed ocular abnormalities. The authors also note that there are decided advantages of fundus photography over the use of the direct ophthalmoscope as it pertains to the field of telemedicine. They conclude that the course of action with the most advantage and improvement in patient safety and quality of care is to empower non-ophthalmologists to perform and review fundus photography routinely, facilitating onward referral as required.

In 2020, the COVID-19 pandemic forced the medical community to reexamine several standard practices and find alternatives for many. Use of the direct ophthalmoscope is among them. A Chinese study published in August 2020 concluded that the direct ophthalmoscope is reaching obsolescence due to factors including infection control concerns surrounding the close face-to-face proximity required for examination, the rise of telemedicine, and the accessibility of mobile handheld fundus cameras. The authors concluded that the transformation in the ophthalmologic standard of care from direct ophthalmoscope to handheld fundus camera is overdue, will be long-lasting, and will be to the benefit of patient clinical care.

Diabetic Retinopathy Is Treatable with Timely Screening

Diabetic retinopathy affects 80% of people who have lived with diabetes for over twenty-five years. Vision loss can be prevented in 95% of these patients with timely intervention. However, only about 63% of people comply with screenings as recommended. This places the other 37% at high risk for unnecessary vision loss and resulting complications, which carry a heavy toll both financially and in terms of quality of life. Researchers have investigated the factors behind the high rate of non-adherence to screening.

Barriers to Diabetic Retinopathy Screening

Many barriers exist that interfere with timely adherence to recommended diabetic retinopathy screening. The accomplishment of widespread timely screening has been identified as a key factor in the prevention of irreversible vision loss, so researchers have examined its barriers at length. Barriers exist on both the patient and the provider side.

Patient-Side Barriers

Patient-related barriers to screening include a lack of awareness or education, financial and logistical challenges, and emotional resistance. Many patients fail to realize the importance of screening, especially in the absence of symptoms. Costs associated with screenings, including co-pays, travel, and taking time off work also contribute. Medicare will not pay for ophthalmologic appointments when no ophthalmological diagnosis exists, so in many cases, responsibility for costs of these appointments falls to the patient. Furthermore, patients often have numerous appointments and health care needs to juggle, and diabetics have, on average, 2.3 times the health care expenditure than their non-diabetic counterparts. Sometimes they are forced to choose between food, other essentials, and health care. In these cases, patients often tend to forego preventative health care.

Patients who participate in cultures that may deemphasize health care, including some rural settings, also choose to mostly overlook preventative screenings. Language barriers may exist for some patients, and emotional barriers are common. These include feelings such as fear, anxiety, and guilt, and patients may hesitate to make a screening appointment. Common themes also include a reluctance to hear “more bad news” and a desire to avoid feeling “blamed” or judged by others for their failure to control blood glucose levels.

Provider-Side Barriers

Barriers exist on the provider’s side as well. A 2015 article published in The Community Eye Health Journal described a few of the provider-side barriers: inadequate advisory services regarding diabetic ocular complications, inefficient systems for getting patients to adhere to appointment recommendations, long wait times for screenings or appointments, difficulties regarding referral processes, and long distances to screening centers.

Novel Thinking—Along with New Technology—Can Overcome Barriers

Patients tend to trust their primary care physicians (PCPs) and are more likely to have regular contact with them than with their specialists. This uniquely positions PCPs to help patients achieve timely screening and treatment and resultantly preserve their sight. By accomplishing routine retinal screening in-office, PCPs can negate the need to arrange and attend additional appointments. This single change can overcome most barriers to diabetic retinopathy screening. Because they are already in the office, there is no need to contend with financial, logistical, emotional, or systemic challenges to schedule or get to another appointment. By pairing annual diabetic retinopathy screening with other routine wellness exams in the PCP’s office, this can be accomplished both simply and efficiently.

Twenty years ago, diabetic retinopathy screening in the PCP office may not have been a viable option. However, technological advancements have made it possible today. Over the last decade, non-mydriatic handheld fundus cameras have made important improvements in image quality. In 2013, the Optomed Smartscope PRO became the first handheld fundus camera to meet the International Organization for Standardization ISO 10940 resolution requirements for fundus cameras. Its 2017 successor, the Optomed Aurora, introduced a full 50-degree field of view, which is especially useful for the detection of diabetic retinopathy. Physicians and experts are taking note and forwarding the discussion.

Experts Are Exploring New Approaches and Starting to See the Results

A study published in March 2007 of Diabetes Care concluded that incorporating digital imaging technology in the primary care visit can significantly improve screening rates and increase access to diabetic eye care, especially for medically indigent individuals.

In a 2014 clinical statement, the American Academy of Ophthalmology recognized validated digital imaging to be an effective method of detecting diabetic retinopathy. The AAO acknowledged that screening programs have great value when access to ophthalmologic care is limited and noted that participation in a photographic screening program is positively associated with adherence to referrals to follow up ophthalmologic examinations.

In 2016, Retinal Physician published an article predicting that telemedicine would streamline the current standard of care as it relates to screening for diabetic retinopathy. It noted the increasing prevalence of diabetes, along with the relative paucity of ophthalmologists available to perform in-office screenings, as factors that would contribute to a growing need for alternative processes. This article acknowledged successful programs in the United Kingdom and certain state facilities in the United States that have implemented tele-ophthalmological screenings for diabetic retinopathy, and concluded that incorporation of further programs into the United States healthcare system would both reduce overall healthcare costs and improve screening adherence.

A study published in the Journal of the American Medical Association’s JAMA Ophthalmology in July 2017 found that rates of retinal screening were about 40% in the United States when patients were referred to ophthalmologists for dilated eye exams. The authors concluded that the introduction of retinal telescreening increased the rates of screening for diabetic retinopathy, particularly among minority and underserved populations.

In November 2018, Ophthalmology Management described a new model of diabetic retinopathy screening at the primary care level. In this model, a non-mydriatic fundus camera would be used to capture an image of each eye by medical assistants after the completion of weight and vital signs. The images would then be transmitted to the ophthalmologist’s office for interpretation by a clinician. Finally, the clinician would prepare a report to the PCP about whether any diabetic retinopathy was discovered and if there was any further need to see a retina specialist. The article also discussed potential pay structure and noted that with relatively few screenings each week, the costs of the camera could quickly be recouped and surpassed.

In March 2019, Retinal Physician discussed the developing field of telemedicine as it relates to digital fundus photography, noting that this field lends itself well to the technology. The article describes operating a fundus camera in a PCP’s office and digitally transmitting images to the ophthalmologist for interpretation, effectively enabling patients to access specialists who may not otherwise be available. The article describes the benefits of handheld non-mydriatic fundus cameras to include several automated focusing, illumination, and alignment features, high-resolution imaging, wide-field imaging, portability, and secure connection to electronic medical record systems.

In 2020, Canada joined Iceland, Scotland, the United Kingdom and Wales, and Ireland in developing national guidelines or programs for diabetic retinopathy screening using handheld non-mydriatic fundus cameras. The Canadian guidelines note that diabetic retinopathy is on the rise and that teleretinal imaging can help address the need for timely and effective screening. The evidence-based proposal includes detailed requirements regarding image definition, quality control, and other considerations. They recommend grading for diabetic retinopathy using two 45-degree image fields or a single wide-field or ultra-wide-field image.

The United Kingdom’s diabetic retinopathy screening program was initiated in 2003 and reached nationwide coverage within five years. In that time, diabetic retinopathy/maculopathy ceased to be the leading cause of blindness in adults aged 16-64 years in England and Wales, with inherited retinal disorders being the new top cause of certifiable blindness in that area. 

The Rise of Handheld Non-Mydriatic Fundus Camera Technology

The transition to handheld non-mydriatic fundus imaging technology is unfolding readily for many reasons. Firstly, it is easy to obtain and start using the equipment. This is by design. Research and development in this field have focused on enabling widespread access to diabetic eye screening. Widespread access requires that equipment is portable and available at an affordable price point. Further, ease of use by non-specialists is a key requirement, as is the ability to produce reliable imagery on a consistent basis.

Affordable Technology

Finnish research-oriented ocular imaging equipment developer, Optomed, is a leading producer of handheld fundus cameras. They provide handheld fundus cameras to major medical technology companies, hospitals, eye clinics, and primary health care offices, as well as to cost-effective screening programs worldwide. Their products are designed to enable widespread access to sight-saving eye screenings, so it is necessarily available at an affordable price point.

Because the learning curve is low, the camera can be put to use almost immediately. 

Because diabetic retinopathy screening is often an untapped revenue stream, many PCP clinics find that this alone enables them to quickly recoup and surpass any initial investment.

Easy to Learn and Use by Non-specialists

In order for diabetic retinopathy screening to be accessible to everyone, the handheld cameras were designed in such a way to be easily learned and used by non-eyecare-specialists.

In April 2019, BioMed Central’s BMC Ophthalmology published findings from a study on diabetic retinopathy screening by non-ophthalmologist physicians using a non-mydriatic retinal camera. The study concluded that general physician grading of images from a quality handheld non-mydriatic camera is sufficient to identify referable diabetic retinopathy and that this can be a valid modality to increase screening coverage.

Even paraprofessional staff with relatively little training can consistently obtain images adequate for the identification of referrable signs of diabetic retinopathy, as was concluded in a study published in July 2017 in Ophthalmologica.

Reliable Imagery

It is critical that retinal cameras produce reliable, high-quality imagery, so this point has been scrutinized by research scientists. An abundance of evidence has shown that imagery obtained from high-quality non-mydriatic handheld fundus cameras is adequate for the identification of several ocular and neurological conditions, including diabetic retinopathy.

In April 2019, Ophthalmology Retina Journal published their findings following a retrospective observational study of a teleretinal screening program, which found a high level of accuracy in the detection of diabetic retinopathy.

In August 2020, Germany’s Graefe’s Archive for Clinical and Experimental Ophthalmology published their findings of a review of ophthalmologic telemedicine in the era of COVID-19. The authors concluded that teleophthalmology is an effective screening and management tool for diabetic retinopathy and other chronic ocular conditions. They noted that there is an expected expansion of the field, well beyond screening, to include more triaging of acute ocular complaints and emergencies at the primary care level.

In November 2020, Eye Ophthalmology Journal published an article that acknowledged the increase in tele-ophthalmologic programs in which portable fundus cameras capture retinal images that are then digitally transferred for interpretation. They noted that this increase is due in part to the cost-effective, portable, and easy-to-use nature of this technology. The authors discussed the importance of quality imagery for accurate diagnosis and reviewed the different types of fundus cameras available for diabetic retinopathy screening and management.

Quick and Convenient

Because non-mydriatic examinations require no eye drops, they can be accomplished quickly and conveniently. The process can be completed in minutes in any darkened room. Patients can drive themselves home immediately following the appointment. These features enable screening to be easily accomplished during a wellness exam or other office visit.

In February 2019, Penn Medicine News featured Christian Hermansen, MD, the medical director for LG Health Physicians Academic Region of primary care practices, who discussed their teleretinal screening pilot program. It began in 2017 with the introduction of teleretinal diabetic retinopathy screenings into many of their thirty-four primary care locations. In their model, when screening was ordered by a medical provider, their trained non-physician staff used non-mydriatic cameras to obtain the images. The screenings took less than ten minutes and frequently occurred during a patient’s routine appointment. Images were read remotely by an ophthalmologist, who reported findings back to the PCP within twenty-four hours. Registered nurse Karissa Ross was among the staff who took fundus photographs. She reported that patients were generally quite receptive to the screenings. They voiced appreciation for the convenience of the screening in the PCP office without having to make a separate appointment with an eye specialist. Many patients had difficulties with transportation, so making travel arrangements to the ophthalmologist’s office in the larger city was a challenge. The article noted that the PCP offices using this pilot program found abnormalities including retinopathy, cataracts, glaucoma, and macular degeneration in about 25% of their patients. When a screening returned such findings, the patient was referred to the ophthalmologist for treatment. Ross noted that when such conditions were found, patients tended to be grateful that they had completed the screening.

Mobile Technology Creates Possibilities Never Before Imagined

Because of its mobile nature, a handheld non-mydriatic fundus camera can work anywhere. This opens the door to possibilities even beyond the exam room in the PCP office. Early innovators have proposed creative ideas to expand screening, including drive-through clinics and home visits to bed-bound patients. As the technology progresses and its use grows, more exciting and novel approaches to overcoming screening barriers will undoubtedly be developed and shared.

Designed to Work Seamlessly with Existing Medical Record Software.

The Optomed Aurora is designed to work seamlessly with existing electronic medical records software. Imaging can easily and securely be transmitted via Wi-Fi or USB drive to a specialist for interpretation. It can also be later assessed for medicolegal reasons.

The Optomed Aurora can be integrated with AI technology software to help support health care professionals and minimize screening costs. Extensive adoption of AI will be one of the most significant changes in health care in the coming years. AI-algorithms support health care professionals and ophthalmologists in eye screening, image grading, diagnosing and treatment planning. With AI, it is possible to extend diabetic retinopathy screenings to reach wider patient groups and diagnose other eye diseases, such as suspected glaucoma or age-related macular degeneration (AMD). 

In addition to eye diseases, by analyzing retinal images with AI it will be possible to also detect signs and risk factors of various cardiovascular and neurological diseases. Due to this, the importance of retinal imaging will significantly increase in primary care.

Advances in Handheld Fundus Camera Technology Open the Doors to Better Detection of Diabetic Retinopathy—Right in the Office of the PCP

As doctors know, better adherence to screening for diabetic retinopathy translates to better prognoses and less vision loss. Despite this knowledge, recommended retinal screenings are not routinely accomplished for far too many diabetics. Obstacles to timely screening include financial, logistical, and emotional barriers on the part of the patient and systemic barriers on the part of the provider’s office.

The cost of vision loss on an individual and global level is profound, with a substantial impact economically and in terms of quality of life. By overcoming barriers to screening for diabetic retinopathy, the immeasurable financial and intangible costs of ocular vision loss can be avoided to a great extent.

With the new generation of non-mydriatic handheld fundus cameras, such as the Optomed Aurora, barriers to diabetic retinopathy screening can be quickly, easily, and affordably overcome. This technology is well on its way to establishing the new front line of diabetic retinopathy screening and detection, right in the hands of PCPs.

Here at Optomed, our mission is to help save the vision of millions of people. By integrating our software and artificial intelligence solutions with our camera, we enable eye screening for everyone, wherever they are. To see how we can equip you to save the sight of more patients, schedule a free consultation!