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The Modern Fundoscopic Exam: Changing How We Detect Blinding Eye Diseases
One of the greatest public health challenges of the twenty-first century is detecting blinding eye diseases for timely treatment.
The Third National Health and Nutrition Examination Survey estimated the prevalence of age-related macular degeneration among Americans over the age of forty to be 9.2%. Pure geographic atrophy, the later stages of age-related macular degeneration, was 16.6 times more likely in patients over age seventy-five than in younger patients—except in African-American and Hispanic patients, in whom pure geographic atrophy was often detected before age sixty.
Primary open-angle glaucoma is another leading cause of irreversible blindness in the United States. Between 4% and 10% of Americans over forty have elevated intraocular pressure, 21mm Hg or higher. About 1% of that group every year will develop glaucoma. Not everyone who has glaucoma has elevated intraocular pressures, but glaucoma can be detected in a fundus exam.
Diabetic retinopathy (DR) remains the leading cause of vision loss in adults aged twenty to seventy-four years. In 2008, 28.5% of US adults over the age of forty had some degree of diabetic retinopathy. The condition affects 80% of patients who have had diabetes mellitus for twenty years or more. It is often unnoticed by the patient until the pathology is advanced, but up to 90% of new cases could be reduced with timely detection followed by appropriate treatment.
With diabetes, the percentages alone don’t tell the story. The absolute number of patients with this preventable disease is staggering.
Epidemiological studies reveal that just in the United States, about 700,000 persons live with diabetic retinopathy. Another 65,000 are newly diagnosed every year. In the United States alone, about 550,000 people experience significant loss of sight from a related condition, macular edema. There are about 75,000 newly diagnosed cases of macular edema every year. These two conditions result in 8,000 cases of blindness a year. The tragedy of blindness caused by vascular complications of diabetes is that detecting diabetic retinopathy in time makes it largely preventable.
Primary care physicians (PCPs) are at the front lines of dealing with this enormous public health challenge. They have the most frequent contact with patients in need of ophthalmic intervention, as well as their trust. They are also convenient, and their services are most likely to be covered by insurance.
Fundoscopic exams by primary care physicians facilitate timely detection, followed by referrals to treatments that can save sight. But primary care physicians cannot be expected to meet twenty-first-century challenges with nineteenth-century technology. Modern fundoscopic exams must be accomplished with fundus photography rather than direct ophthalmoscopy.
What is the role of direct ophthalmoscopy in the modern fundoscopic exam?
In 1850, a young German physician named Hermann Ludwig Ferdinand von Helmholtz reported his observations with “an instrument that allows the retina to be seen” to the Physical Society in Berlin. Over the next 100 years, his instrument evolved into the direct ophthalmoscope, the primary tool of fundoscopic exam in the twentieth century.
Every physician is familiar with the direct ophthalmoscope. Light from a bulb is reflected at right angles through the patient’s iris to illuminate the fundus. This reflection requires a prism or a mirror. The healthcare professional sees the fundus directly through the patient’s iris.
The care provider’s view through the direct ophthalmoscope is narrow field, 5 degrees, monocular, non-stereoscopic (2D), and magnified no more than about fifteen times. That said, the instrument can be adjusted to suit the diagnostic task at hand. A wheel contains lenses of different powers that the examiner can bring into the line of sight to correct refractive error, either on the part of the patient or the examiner (if the examiner is not wearing corrective lenses). The physician looks just above the prism or mirror.
Direct ophthalmoscopes have a smaller aperture for examining undilated pupils and a larger aperture for dilated eyes. There is a slit aperture for the lamp, and the brightness of the light can be adjusted by rotating the collar that also houses the on-off button.
There is consensus that teaching direct ophthalmoscopy in medical school helps doctors in training develop general skills in relating to patients in physically close settings. There is no doubt that the direct ophthalmoscope is affordable and portable. It was part of the doctor’s bag in the era of home visits, and it helps medical students learn the anatomy of the eye. But that doesn’t mean it is the best tool for the modern challenges of detecting diseases of the eye.
In 1850, direct ophthalmoscopy was revolutionary new technology. In 1950, it was essential equipment for every primary care physician. But in 2020, several serious limitations make direct ophthalmoscopy a less-than-ideal choice for the modern fundoscopic exam.
What are the limitations of direct ophthalmoscopy in the fundoscopic exam?
Direct ophthalmoscopy has a limitation that causes repeated problems for many primary care physicians: battery-powered medical instruments need charged batteries. It is easy to forget that even a simple instrument like a direct ophthalmoscope needs maintenance. The instrument also needs to be kept in its case (and switched off) when not in use.
Batteries should be removed from ophthalmoscopes if they are not going to be used for more than two weeks, to prevent leakage. Some ophthalmoscopes are designed with a shutter for the viewing window. The shutter should be closed when the instrument is in storage, to prevent the accumulation of dust.
But the primary challenges of direct ophthalmoscopy in fundoscopic exams are technical limitations, one of which was especially relevant during the COVID-19 pandemic.
Direct ophthalmoscopy requires cheek-to-cheek contact of physician and patient.
Social distancing is not possible with direct ophthalmoscopy. The physician may need direct physical contact with the patient. Since researchers have confirmed that COVID-19 is transmissible through the conjunctiva, direct ophthalmoscopy should only be performed in emergency conditions.
Moreover, medical students are currently deprived of patients with whom to practice their technique and can only learn technique through simulations. Direct ophthalmoscopy skills might be limited in younger physicians in the years to come.
Direct ophthalmoscopy is a tedious process.
The field of vision in a direct ophthalmoscope is limited. Even for emmetropic patients, the field of view is limited to two disc diameters. This corresponds to just 7mm2 of the retina’s 1000-1200mm2 surface. In myopic patients, the field of vision is even smaller. In older patients, lens opacities can severely limit visualization of the retina.
Even when patients are entirely asymptomatic, it is necessary to visualize at least 170-degree and up to 220-degree “fields of view” to detect a lesion with a width of two disc diameters.
The diameter of the optic disc is typically 1.2 to 2.5mm. Lesions close to the optic disc caused by diabetic retinopathy often have a diameter of less than 2mm. Most lesions have a diameter of less than 5mm. This limitation makes direct ophthalmoscopy insensitive for the detection of diabetic retinopathy.
Direct ophthalmoscopy is monocular.
Examination with a direct ophthalmoscope lacks stereopsis. It does not facilitate depth perception. This shortcoming affects both fundoscopic exams and examinations of other structures of the eye.
Direct ophthalmoscopy does not have magnification sufficient to help users avoid a common error.
The cilioretinal artery may loop over the margin of the temporal disc and be misidentified as a harbinger of new vascular development.
Direct ophthalmoscopy does not access the periphery of the retina.
Direct ophthalmoscopy lacks access to the pre-equatorial retina. This limitation impedes recognition of post-traumatic involvement of the anterior segment and of the pre-equatorial retina.
The necessity of examining patients in their supine position can lead to back torsion for the primary care physician.
When the patient cannot sit up or be brought to an upright position for the exam, the length of the exam can create back pain in the examiner.
Tear-filled eyes cannot be dilated.
Dilation is not possible if the patient is crying or has tear-filled eyes for any reason. Except in emergencies, the examination has to be delayed.
Examination of the macula should take place last.
Because the macula is the most light-sensitive structure, in a fundoscopic exam, it is examined last, giving the examiner less time to explore macular pathology.
Direct ophthalmoscopy of the optic disc entails assessing a monocular view of a sometimes highly mobile target.
Even in cooperative patients, accommodation to the bright light of the ophthalmoscope causes the pupil to constrict. Fear from the patient or the novelty of the exam can lead to eye movements that make visualizing the fundus difficult.
In urgent care situations, physicians simply do not have the time to use direct ophthalmoscopy.
The FOTO-ED study found that only 14% of physicians used direct ophthalmoscopy to do fundoscopic exams for patients who had headaches, focal neurological deficits, visual changes, or diastolic blood pressure (>120 mm). However, that does not mean that physicians do not appreciate the value of a fundoscopic exam for those conditions. When the same physicians were provided with access to non-mydriatic fundus photography for patients with those conditions, the fundus photos were considered in 68% of cases.
The images generated by direct ophthalmoscopy are only viewed once, by the examining physician.
A fundoscopic exam by direct ophthalmoscopy does not create any kind of permanent objective record, although the examiner can sketch what is seen. Lesions cannot be measured, and patients cannot be shown their pathology except by viewing a sketch. The exam requires the primary care physician or ophthalmologist to be physically present, and what is seen by the examiners cannot be shared.
This also means that support staff cannot assist in direct ophthalmoscopy, and without a record of the examination, there is no separate billing code.
Fundoscopic exams by direct ophthalmoscopy are insufficient for the timely detection of sight-threatening diseases.
There is evidence in the literature that direct ophthalmoscopy cannot play a primary role in the detection of progressive eye disease.
- Subretinal drusenoid deposits in age-related macular degeneration are dynamic. They expand and recede. Without a photographic record of the fundoscopic exam, it is difficult to track the progress of the disease.
- Cupping of the optic disc is a reliable early warning sign of primary open-angle glaucoma for patients who are not yet symptomatic. But because of difficulties of directly viewing the optic disc through an ophthalmoscope, the North of England Eye Study found that even 40% of ophthalmologists missed this symptom when using only an ophthalmoscope alone to examine patients to find glaucoma.
- Four studies sponsored by the United Kingdom’s National Health Service recommended discontinuation of direct ophthalmoscopy alone for the detection of diabetic retinopathy because it consistently failed to meet an 80% sensitivity standard.
- Elderly patients tend to have smaller pupils. Examination of elderly patients frequently takes place in well-lit environments, making direct ophthalmoscopy of dubious value in disease screening at nursing homes or care facilities.
Simply attempting a fundoscopic exam is not good enough. Fundoscopy needs to be accurate and reliable.
What about replacing direct ophthalmoscopy with a smartphone?
Not doing eye exams is perilous because that can lead to delayed diagnoses and treatment. Clinicians are loath to miss opportunities to perform non-invasive in-vivo assessments of retinal integrity, vasculature, and the optic nerve head, as well as to ensure early detection of age-related macular degeneration and diabetic retinopathy.
At first blush, the smartphone has obvious advantages over the direct ophthalmoscope. It can be operated at a greater distance from the patient, thus reducing COVID-19 risk (although a smartphone still cannot be operated within social distancing guidelines).
Younger physicians and most support staff are more confident in their abilities to operate a smartphone than an ophthalmoscope. Primary care physicians and non-physicians alike can send images to ophthalmologists for definite diagnosis.
But the smartphone also has its limitations.
- The smartphone has a 20- to 30-degree field of vision, compared to just 5 to 8 degrees for direct ophthalmoscopes. However, this means it is still necessary to make about forty views of the fundus to be assured of detecting a lesion of two disc diameters.
- A montage of smartphone images can be constructed with the smartphone, but recent studies suggest that smartphone images that are useful for eye disease detection require dilation.
- The Ophthalmological Society of the United Kingdom found that fourth-year medical students were significantly better at describing certain ocular conditions with a smartphone than with direct ophthalmoscopy—for example, age-related macular degeneration, central retinal vein occlusion, optic atrophy, and pre-proliferative diabetic retinopathy. However, detection rates only improved from less than 50% to about 60%.
Examination of the ocular fundus is critical for accurate diagnoses of many sight- and life-threatening medical conditions. There is consensus that all generalist physicians should be proficient in fundus examination. Standards specifically require physicians to be able to visualize the retina, the optic disc, and the red reflex. Generalist physicians should be able to assess the optic disc for color, contour, cupping, edema, margins, and vessels.
Most generalist physicians find that traditional direct ophthalmoscopy is a suboptimal tool for diagnoses of eye conditions. The smartphone is a significant improvement, but a better standard is that a D-EYE for smartphones is required for detecting the conditions that threaten sight.
The advantages of a truly modern fundoscopic exam
Optomed is a dedicated camera system for the modern fundoscopic exam. It retains all of the advantages, while overcoming the limitations of direct ophthalmoscopy and examination by smartphone. Optomed provides superior results in patient care. It also addresses the limitations of direct ophthalmoscopy with an extraordinarily scalable technology.
The portability of Optomed enables accurate DR screenings across multiple clinical sites. Even non-professional volunteers can be used for walk-in mass screenings, taking fundus photographs to be assessed by physicians and other professionals at a distant site.
The use of Optomed fundus photography provides superior sensitivity in the detection of diabetic retinopathy. Optomed Aurora behaves better than tabletop cameras for non-mydriatic conditions in diabetic retinopathy screenings, especially for patients who cannot have dilation due to glaucoma. Optomed affords equal performance to tabletop cameras when the eyes are dilated.
Let’s review the advantages of Optomed:
- The Optomed Aurora requires a single photograph, not dozens or even hundreds of manual searches of the retina.
- The Optomed Aurora gives a 50-degree field of view, not just a 5- to 8-degree field-of-view, like that of the direct ophthalmoscope, or a 30-degree field-of-view like that of a smartphone.
- The Optomed Aurora Camera is in power save mode while placed on Optomed Aurora Charging Station and is powered on when lifted.
- The Optomed Aurora is a handheld, mobile screening device with the convenience of a smartphone. Its use is not limited to one office location. Physicians can use its fundoscopic camera technology for diabetic retinopathy screening at all their offices or even in the field at screening fairs.
- Physicians and staff can learn how to use the Optomed Aurora in just a few brief training sessions.
- Optomed Aurora can access artificial intelligence for recognizing patterns indicating eye disease.
- Optomed is the answer for increased surveillance to timely detection of many of the diseases that threaten sight.
How do these features of Optomed keep primary care physicians in the loop for detecting diabetic retinopathy?
Primary care physicians already guide their patients to manage the risk factors for diabetic retinopathy: HbA1C, cholesterol, blood pressure, and smoking. Optomed fundus cameras empower another service: detecting diabetic retinopathy in a timely manner. Optomed makes this a scalable, affordable service that primary care physicians can offer their diabetic patients.
The tools of diagnosis are ultimately ineffective if patients don’t make their appointments so the doctor can use them. Optomed provides primary care physicians a salient incentive for patient compliance: screenings for diabetic retinopathy and other sight-threatening diseases can be done in the course of primary care, giving the physician an opportunity to counsel the patient from a position of trust.
The Optomed Aurora minimizes patient discomfort during screening. It enables fundus imaging without any need to dilate the patient’s eyes first. Patients find this feature quite attractive because it means they can drive themselves home from the exam, they lose less time from work, and they spend less time in the doctor’s office, requiring fewer COVID-19 precautions.
The Optomed Aurora addresses another salient issue in a patient-centered model of retinopathy care: patients realize a financial advantage from getting their screenings for diabetic retinopathy from their PCPs. Not every patient has an in-network retina specialist within a reasonable driving distance, or their health insurance plans may require considerable copays and long drives.
Retina scans by an ophthalmologist usually are not covered if there is no diagnosis. Fees for screenings by retina specialists can easily be out of reach for Medicare patients. Such financial hurdles to detecting diabetic retinopathy do not occur when the diagnosis is made by a primary care physician with the Optomed Aurora.
What about financial incentives for the primary care physician?
Optomed potentiates profitable and ethical ancillary care in primary practice.
There is general agreement that professionals and patients alike tend to equate new technology with a higher standard of care. However, capital investments in new technologies create financial pressures on practitioners to use those devices in routine examinations.
This is not an issue with Optomed. The Optomed Aurora technology is affordable and scalable, and when used in appropriate patient populations, it generates a necessary and ethical benefit to patients. Ancillary procedures with a medical indication, such as a screening for age-related macular degeneration, meet the requirements for reimbursement by insurance and CMS.
The Optomed Aurora is scalable technology at an affordable price point. It answers a largely unmet need by involving primary care physicians in detecting diabetic retinopathy.
Do you need more specific information about reimbursement for a fundoscopic exam?
The Centers for Medicare and Medicaid (CMS) issued final rules for updating the 2019 Medicare Physician Fee Schedule in November 2018. There are three billing scenarios in which a patient can receive a retinal exam in their primary care physician’s office, with fundus images being interpreted by a qualified eye care professional (such as an ophthalmologist or an optometrist) at a remote site. Each scenario fits a storage and retrieval system like Optomed. The CPT codes for these scenarios and their reimbursement rates are:
- Reimbursement code 92250, fundus photography with interpretation and report, reimbursed $52.25 to $74.37
- Reimbursement code 92227, remote screening for detection of retinal disease, reimbursed $12.97 to $20.12
- Reimbursement code 92228, remote imaging for management of active retinal disease, reimbursed $31.44 to $43.41
Optomed facilitates HEDIS improvements.
According to Retinal Labs, retinal exams are now included in the Medicare Advantage STARS and Medicare quality ratings programs for all patients who have diabetes. Traditionally, diabetic patients could only be referred by the primary care physician to eye care specialists for a fully dilated eye exam. Evidence has shown that many diabetic patients fail to follow through with their appointments with the ophthalmologist.
CMS often imposes financial and/or contractual penalties on health plans that score low on HEDIS measures and Star Ratings. “Preventative screenings are a key component of payer quality improvement strategies,” states Retinal Labs. Commercial health insurance and Medicare Advantage payers are increasingly offering financial incentives to primary care physicians for compliance gap closure, including diabetic retinopathy exams. By offering diabetic patients a convenient retinal exam as part of their routine visit, primary care physicians can take charge of their diabetes quality measures and unlock lucrative payer-based financial incentives by offering patients with diabetes a convenient retina screening as part of a primary care visit. For example, United Healthcare’s PATH quality improvement program has paid out over $150 million to 1,900 primary care physicians for closing gaps in diabetic retinopathy and cancer screenings. That payout computes to $77,000 per primary care physician.
Optomed also assists in risk adjustment.
Rewards for risk adjustment create an additional incentive for diabetic retinopathy screenings. For providers, accountable care organizations, and health systems with contracts based on risk, detecting ocular disorders can result in significant increases in capitation payments. There is clinical evidence that over 35% of patients screened with camera-based fundoscopic exams are diagnosed with an ocular disease that would otherwise have been missed. Retinal Labs states that “this includes detection of diabetic retinopathy, glaucoma, age-related macular degeneration, cataracts and surface diseases.”
Revenue enhancement is not limited to the screening procedure. Primary care practices should consider increased revenue from all sources.
Fundoscopic exam with Optomed helps primary care physicians deal with emotional resistance to eye exams.
Some of the most significant barriers to follow-up with primary care physician recommendations for diabetic retinopathy screening are emotional. Many patients with diabetes feel surveilled and criticized by family members and the community for their issues in diabetes management, and the negative feelings that result can interfere with the self-efficacy and self-esteem needed for adhering to guidelines for annual retinopathy screenings. Others avoid the ophthalmologist because they have limited tolerance for more bad news. These are patients who know that they need help with their habits, and they do not find that help from their retina specialist. So, they rely on their primary care physicians.
But at least one study has found that 81% of diabetes patients will follow up with retinopathy screenings and treatment when their primary care physician gives them a strong rationale to do so.
Primary care physicians are ideally suited to providing retinopathy education because they are more easily accessible to patients. Patients also trust their primary care physicians, and some patients are far more likely to find retinopathy screening palatable when it is done in the primary care physician’s office with Optomed.
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 today!