Picture the following: It’s a routine Tuesday morning at work. Your first scheduled appointment is a new patient. He's a 33-year-old carpenter, in for a routine eye examination because he’s been having issues driving at night.
He tells you that he intentionally booked the first appointment because he has a full day of work ahead of him, and absolutely does not want “those drops” because he “can’t afford to be blurry and light-sensitive all day long.”
He volunteers no history of ocular disease, but claims to have suffered a few eye injuries and foreign bodies over the years due to his vocation. He also has a strong family history of diabetes.
If this scenario makes you a little uneasy, you’re probably not alone. After all, the current standard of care for all new patients involves performing a comprehensive eye exam, and that includes a dilated fundus examination (DFE) unless medically contraindicated.
Additionally, the history in this case suggests a greater potential for ocular pathology than might otherwise be anticipated in a young, healthy patient. How should you proceed? How would you proceed?
Patient inconvenience vs. comprehensive care and medical necessity
There’s not a physician among us who wasn’t taught that dilation is a crucial component of any comprehensive eye examination, and that excluding this procedure can result in a host of potential problems for both the patient and the doctor.
Similarly, there’s hardly an eyecare provider (ECP) who hasn’t experienced the discomfort and inconvenience that goes along with being pharmacologically dilated, and so we empathize with patients who are reluctant to undergo this portion of the exam.
Understanding how routine dilated funduscopy can disrupt patient routines
In the past, we’ve had very few options for patients who pushed back against dilation. We would typically discuss the potential adversities associated with the drops, reassuring patients about their transient nature and explaining why it was important to reconsider, and hope that the patient would eventually relent.
If they did, we would proceed; if they did not, we might offer the patient an option to return later for the dilation only, or ask them to sign a “dilation waiver form,” or simply say, “We’ll do it next time.”
The situation is arguably different today, however. Among other things, attitudes toward doctors and medical care have changed dramatically over the last 30 years. Some might even say that we’ve gone from a generation of patients to a generation of “healthcare consumers,” and, as we know, consumers drive business decisions—ultimately impacting how we as doctors discharge our medical obligations.
When we stop to think about it, it’s not surprising that patients don’t particularly enjoy being dilated. For nearly every individual, dilation serves to increase light sensitivity, glare, and visual discomfort from optical aberrations, all secondary to pupil enlargement; these factors can greatly impact driving ability and a host of other activities.
The intensely bright lights associated with funduscopy are not terribly pleasant, either. Also, for those early and pre-presbyopic individuals, near work after dilation is not only uncomfortable, it can be downright impossible. Lastly, dilation is a time-consuming prospect when we consider the additional hour or so spent in the office, as well as the multiple hours that it may require to fully return to baseline.
Studies on the medical necessity of routine dilated funduscopy
As to the medical necessity of routine dilation, any experienced ECP can tell you that the vast majority of their asymptomatic patients are without significant ocular pathology.
In a study published more than 25 years ago, researchers conducted a retrospective review of nearly 4,000 patients who presented without a visual or medical complaint, or with a purely refractive complaint in order to identify those with observable fundus pathology.
The results of this study are detailed in Table 1. In addition to revealing very low rates of disease, the pathological findings that were discovered and found to be clinically significant tended to be skewed toward older individuals within the population (Table 2).1
Table 1: Adapted from Pollack et al.
Table 2: Adapted from Pollack et al.
A more recent publication by optometrists at the University of Montreal found somewhat different results, however.2 In their retrospective study, over 2,500 charts of patients seen for comprehensive ocular examination were reviewed, with a total of 846 meeting their inclusion/exclusion criteria.
Individuals with a history of ocular pathology or the presence of characteristic symptoms were excluded. Likewise, patients with high myopia were excluded if this was the specific reason for their visit; however, if individuals in this group were asymptomatic and denied any knowledge of existing retinal conditions, their records were included.
In all, 220 individuals (26.1%) were found to have at least one asymptomatic ocular condition on examination; of these, 157 (18.6%) had pathology of the posterior segment, with 65 (7.7%) manifesting peripheral retinal abnormalities (e.g., atrophic holes or lattice degeneration).2
While the incidence of potentially problematic retinal findings in asymptomatic individuals is arguably low by any standard, the two aforementioned studies demonstrate the variability that can be encountered in different practice settings.
Shane Kannarr, OD, managing member at Kannarr Eye Care in Pittsburgh, Kansas, states that the vast majority of patients in his practice are routinely dilated. He acknowledges that many patients don’t particularly enjoy the process, but in his mind, it is about providing the most comprehensive care while also trying to offer the best possible patient experience.
He acknowledges that there are circumstances in which dilation can be problematic, as in the case of latent hyperopes, young patients with scheduled activities that depend on crisp, clear vision, and older patients in whom mydriatic-induced glare can be debilitating and make driving a hazardous undertaking.
Routine dilated funduscopy and the standard of care
Regardless of opinion, routine dilated fundoscopy remains the standard of care in most cases for both optometrists and ophthalmologists in the United States.3,4 And, as we’re aware, “standard of care” is a legal term that represents the degree to which a prudent and reasonable person would exercise care under the circumstances.5
In healthcare, this is the benchmark that determines whether our professional obligation to a patient has been met, whereas the failure to achieve this standard represents clinical negligence.
So, while most ECPs understand that (1) routine dilation represents the standard of care in our respective professions, and (2) the standard of care is a legal construct, then might we naturally conclude that routine DFE is mandated by law?
The answer to this question, like so many others in healthcare, is, “It depends.” The variables governing the answer to this question include the specific state or commonwealth in which the doctor practices (particularly for optometry), but also whether or not the physician has signed an agreement with a third party payor to provide services, and whether or not those services include a DFE.
Failure to perform a DFE is certainly not a criminal offense, however, it may predispose a physician to civil action; this may take the form of a record audit and potential fines in the case of a breached contract with a commercial insurer, or a malpractice suit if there is evidence of negligence and resultant harm to a patient.
Political bodies have also weighed in on the topic. The American Optometric Association (AOA) states that dilation is not specifically required for a doctor of optometry to code either a comprehensive eye exam (92004 and 92014) or an intermediate exam (92002 and 92012).
Moreover, in 2021, the Centers for Medicare & Medicaid Services and the American Medical Association released new definitions and guidelines for billing Evaluation and Management (E&M) codes. These E&M codes no longer define what the components are in an eye examination, but rather require the provider to perform “a medically necessary” examination.6
Informed consent for dilated funduscopy
As challenging as it may be to convince patients that dilation is medically necessary, we must also acknowledge that the risks posed by this procedure, while low, are real and not insignificant. Dilation in and of itself can impact critical visual tasks such as driving, potentially introducing new risks to the patient.
Hence, as we strive to convince patients to put their medical needs before convenience, we must always consider the burden that this places on them and ensure their safety. As with any procedure that has a potential for negative outcome, we are obligated to provide and document appropriate informed consent.
Dr. Kannarr notes that there is no legal mandate to employ informed consent for dilation, and his practice is among those who do not use such a form routinely. Still, he acknowledges that numerous practices do.
The primary motivation for this may simply be to obtain a signed release from patients who refuse the procedure; however, informed consent also serves as a means to ensure that patients who are dilated accept the inherent risks, particularly as it applies to the visual impact on critical tasks, most notably driving. Sample verbiage from one such informed consent document is included in Figure 1.
Utilizing informed consent to provide the option of deferring and returning for the DFE is just one management strategy for facilitating dilation in apprehensive patients. It has the advantage of requiring no additional equipment or associated costs, although it may increase office and chair time for both the doctor and patient to some degree.
From a legal context, informed consent does not completely absolve the practitioner from their patient obligations, and does not preclude the possibility of a lawsuit in cases of undiagnosed pathology with a negative outcome, but it certainly does provide an additional layer of “insurance.”
For anyone who refuses dilation entirely, the form should be signed and dated by the patient (and/or legal guardian), and countersigned by the physician (and/or a designated office representative), indicating that the choice to forgo dilation was entirely the patient’s, and that they understand the implications of their decision.
If the patient expresses a desire to return for DFE at a later date, all efforts must be made to schedule said follow-up, and communicate/reschedule if that appointment is missed (all with appropriate chart documentation).
Figure 1 is a sample informed consent form for dilated fundus examination.
Figure 1: Courtesy of Alan G. Kabat, OD, FAAO.
Comparing nonmydriatic UWF imaging and DFE
Another alternative to dilation, which has become popular over the past 25 years, is nonmydriatic ultra-widefield (UWF) imaging. The International Widefield Imaging Study Group defines UWF as the ability to visualize the retina anteriorly to the vortex vein ampullae in all four quadrants with a single image-capture centered on the fovea.7
UWF imaging typically corresponds to a field of view between 110° and 220°.8 The most widely utilized of these imaging platforms allows for visualization of up to 200° of the retina, or 82% of the total retinal surface area, even through an undilated pupil.9,10
Figure 2 highlights a UWF image of the fundus through an undilated pupil; note the atrophic retinal hole at the 5 o’clock position.
Figure 2: Courtesy of Alan G. Kabat, OD, FAAO.
Since the advent of UWF technology, advocates have attempted to position it as a viable substitute for routine dilation, particularly in those asymptomatic refractive patients who have a low risk for ocular disease.11 Indeed, the prevailing attitude is that UWF can be an effective screening tool for such patients, identifying those in whom dilation with extended ophthalmoscopy is specifically indicated.
However, ECPs must realize that DFE remains the standard of care, as it facilitates visualization of up to 240° of the retina, more than any imaging technique can provide through an undilated pupil. In other words, nonmydriatic UWF may fail to reveal some far peripheral retinal disorders, especially those in the superior and inferior periphery, that may be visualized through dilated indirect ophthalmoscopy.
To this point, a study of 1,725 myopic eyes showed that UWF imaging had only 57% sensitivity for peripheral retinal holes and 65% for peripheral retinal degenerations as compared to dilation and examination with a Goldmann 3-mirror contact lens.12
From a malpractice perspective, ECPs who rely solely on UWF imaging and forgo the DFE may still be culpable of negligence if peripheral retinal disease is not detected during the examination, and the patient ultimately goes on to lose vision.
Dr. Kannarr is an advocate of UWF imaging, specifically the Optos system (Optos, Inc.; Marlborough, MA) and utilizes it in his office to identify potential pathology as well as to provide information toward “directed dilation.”
In other words, he will screen patients with the camera, but always relies on his clinical examination through dilated pupils in order to make or confirm any potential diagnoses. Another advantage to imaging in this fashion is that it provides documentation and the ability to screen for changes over time.
Options for pharmacologically-induced mydriasis
So, if informed consent and nonmydriatic imaging cannot yield the appropriate and desired results from a clinical or clinicolegal point of view, what other options exist for patients who are reluctant or dismissive regarding dilation?
Pilocarpine
One logical option might be dispensing a drop to pharmacologically counteract the effects of mydriatic agents. In fact, reports from as recently as 20 years ago tell of ECPs using pilocarpine, a direct-acting cholinergic agonist primarily indicated for glaucoma, to occasionally enhance the recovery from pharmacologic dilation.13
However, the adverse effects of pilocarpine are well-documented, including conjunctival hyperemia, burning on instillation, brow-ache, headache, and pseudomyopia—a condition that ensues due to overaction of the ciliary muscle.14
Additionally, there have been reports of pilocarpine-induced vitreofoveal traction and retinal detachment.15,16 Given the array of undesirable qualities and potential outcomes associated with this drug, it cannot be considered an option for routine reversal of mydriasis.
Dapiprazole
Because of the challenges posed by pilocarpine, researchers began seeking an alternative for the reversal of pharmacologically induced mydriasis with an inherently better safety and efficacy profile. As far back as the 1980s, dapiprazole, an alpha-adrenergic antagonist that induces miosis by blocking receptors on the dilator muscle of the iris, was the subject of intense research.17,18,19
Unlike pilocarpine, dapiprazole produces no significant action on ciliary muscle contraction, and thus, there is little impact on accommodation and no changes in the depth of the anterior chamber or the thickness of the lens.18,20
In December of 1990, dapiprazole 0.5% ophthalmic solution was approved by the US Food & Drug Administration (FDA) under the trade name Rev-Eyes for the treatment of iatrogenically induced mydriasis, gaining instant notoriety among ECPs.
Unfortunately, while dapiprazole was a far better option than pilocarpine, it still had its challenges, primarily in the form of adverse reactions. Despite favorable clinical studies, the drug tended to work somewhat slowly in practice, taking as long as 2 hours in some cases to return pupils to their pre-dilation status.18
Additionally, stinging upon instillation occurred in a significant portion of patients, and conjunctival hyperemia was encountered in more than 80%.21,22 From an ECP standpoint, the drug also had substantial limitations; it was priced roughly four to five times more than typical diagnostic drugs, and once opened, each bottle had a shelf life of only 21 days.22
For these and a host of other issues, Rev-Eyes was voluntarily removed from the US market at some point in the early 2000s, though not for reasons of safety or efficacy as determined by the FDA.23 A smaller, independent US laboratory attempted to market a generic version of dapiprazole called NUREV in the late 2000s, but that product was also short-lived due to similar challenges.24
RYZUMVI
There is now a third pharmaceutical alternative in phentolamine, a topical agent indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.25
RYZUMVI (phentolamine ophthalmic solution) 0.75% is a non-selective alpha adrenergic antagonist that inhibits contraction of smooth muscle; when dosed topically in the eye, the drug works directly on the radial muscles and indirectly on the sphincter muscles to diminish pupil size without impacting the ciliary muscle.26,27
In the MIRA-2 and MIRA-3 clinical trials involving over 550 subjects, phentolamine 0.75% ophthalmic solution met both its primary and secondary endpoints. Those treated with phentolamine showed a significantly faster mean return time to within 0.2mm from the baseline pupil diameter, as compared with placebo, occurring as early as 60 to 90 minutes following instillation.28
Outcomes were similar for subjects dilated with phenylephrine 2.5%, tropicamide 1%, or Paremyd (hydroxyamphetamine hydrobromide 1% + tropicamide 0.25% ophthalmic solution), as well as subjects with either light or dark irides.
The most common adverse reactions were instillation site discomfort (e.g., pain, stinging, and burning) in 16% and conjunctival hyperemia in 12%. Dysgeusia was also reported in 6% of subjects.25
Table 3 summarizes the pharmaceutical agents that have been employed for the reversal of mydriasis.
Table 3: Courtesy of Alan G. Kabat, OD, FAAO.
Practical experience with phentolamine mydriasis-reversing drops
Dr. Kannarr has vast clinical experience using drops to reverse mydriasis. While he agrees that pilocarpine is not a viable option, he has used both dapiprazole and phentolamine in his practice.
Like many of us, he remembers Rev-Eyes more for its adverse reactions than for its utility in clinical practice. “Patients were not terribly happy with that particular drop, so we stopped using it pretty quickly,” he recalls.
Dr. Kannarr’s practice was involved in the clinical trials for phentolamine, so he has significantly greater experience with this product than most other practitioners. Since its approval, he has also been offering phentolamine for the reversal of mydriasis to patients in his practice.
When asked about his views on the subject, Dr. Kannarr states, “It’s all about building a better patient experience. The vast majority of our patients are dilated, and therefore, we think that it’s something worth offering.
We’re currently using it selectively for those types of patients I mentioned earlier—latent hyperopes, younger patients with busy schedules and active lifestyles, patients with macular degeneration (due to the effects of increased glare and halos on already compromised acuity), and, of course, the low-hanging fruit, patients who just hate being dilated. Now we have an option for them.
Currently, it’s just myself and a few select, highly-trained, and educated staff who may discuss this as an option prior to or during the exam, but we’re actually in the process of creating a check-in form to alert all of our patients to the fact that we offer this service. However, we will still continue to reinforce it verbally to those individuals where we feel it is most appropriate.”
When asked about the financial aspect of using mydriasis-reversing drops, Dr. Kannarr was very clear. “We’re viewing this less as a potential revenue stream and more of a way to elevate our level of care and provide greater service to our patients.
It is not at all disruptive to our office flow, and it takes only a few seconds more of chair time, especially if we delegate drop instillation to our highly trained staff. Our markup on the net cost of each vial is about 87%, and we’re considering lowering that fee to perhaps just 25%.”
Finally, Dr. Kannarr is very careful to underpromise and overdeliver when it comes to reversing dilation with phentolamine. “We don’t tell our patients that they're going to be back to baseline when they leave the office; instead, we say that it’s going to help you get rid of the dilation quicker. On average, we’re seeing patients feeling normal again in about 1 to 2 hours following instillation. Most patients seem to be very content with it in this context.”
Conclusions
Although it is an essential component of the comprehensive eye examination, pupil dilation can hardly be described as an enjoyable experience. At best, patients tolerate this procedure because they understand it is vital to ensure that their eyes are free from potentially sight-threatening pathology.
It can also be argued that dilation adds additional time and workflow challenges for ECPs and staff in busy office settings. However, dilated fundus examination remains the standard of care within optometry and ophthalmology in terms of diagnosing peripheral retinal disorders, with no alternatives offering similar or better accuracy at the present time.
Currently, the best option for patients who are apprehensive about the consequences of undergoing a DFE is to employ a “dilation reversal” agent, i.e., phentolamine, which has been shown to be effective and well-tolerated in clinical trials.
Informed consent and UWF imaging can be useful adjuncts, and can even help to alleviate some of the burden temporarily, but we must recognize their clinical and clinicolegal limitations, and never consider them to be replacements for pharmacologic dilation.
