In 2021, members of the American Optometric Association (AOA) Contact Lens & Cornea Section (CLCS) were asked to identify controversies in contact lens practice. Based on their input, this 2022 “Clinical Controversies” article encompasses both current and future considerations.

The COVID-19 pandemic has emphasized not only the importance of eyecare providers, it also has emphasized that contact lenses are safe to wear when appropriate safety standards are observed. The focus on the current myopia pandemic continues to intensify along with increasing education on this topic. Recently, the first U.S. Food and Drug Administration (FDA)-approved pharmaceutical option for correcting presbyopia was introduced. Such options will change the future of eye care. Read on for a potpourri of controversies from the AOA CLCS.

CONTROVERSY 1: EMPIRICAL VERSUS DIAGNOSTIC FITTING IN A COVID WORLD

Empirical Fitting The 2018 International Organization for Standardization (ISO) guidelines for multiuse disinfection, coupled with the recent SARS-CoV-2 pandemic, underscore the need for alternatives to reusable lenses and to diagnostic fitting.¹ Advancing technologies have answered the call.

In the mid-2010s, videokeratographers began to showcase advanced contact lens fitting algorithms based on elevation maps.^2-4 These algorithms have continued to improve, and they can provide an excellent initial design for many corneal GP lenses. Such empirically designed lenses can offer an outstanding first-lens experience for patients, and often they are the only lenses that patients need.

Today, scleral profilometers are expanding the options for empirical fitting. Multiple instruments now provide initial recommendations for scleral lenses.⁵ These instruments scan the scleral profile, select a lens design, and recommend initial lens parameters. Once the initial lens is chosen, the calculations can be exported to the manufacturer’s site for further customization. Usually, the recommendation is to apply a diagnostic lens that is similar, then over-refract to finalize the power. While slightly less accurate, an initial lens power can be calculated based on a patient’s habitual lens or based on central keratometry readings, refraction, and the recommended lens base curve.

In addition to standard scleral lens designs, fully scan-designed initial lenses can be created. A lens that is designed based on scleral shape can help prevent lens rotation and improve the fitting relationship, which can streamline examination time, reduce lens reorders, and improve a practice’s bottom line.⁶

The latest advance in profilometry is software for designing custom orthokeratology (ortho-k) lenses. After a patient’s ocular surface is scanned and the prescription is entered, the software calculates the first lens. When follow-up data is input, the software can make recommendations for parameter adjustments.

One of the advantages of empirical fitting is that it minimizes the risks associated with concurrent infections. Hepatitis C, adenovirus, prions, and human T lymphotropic virus, in addition to a variety of others, have all been identified in tears.^7-10 When patients are infected with one of these viruses, diagnostic lenses used on them should be discarded. Unfortunately, it is not always known when our patients have these infections. The level of disinfection required to meet ISO guidelines can put a burden on a practice.¹ The parameters must be logged, and while the lenses soak for three hours, practitioners must keep track of the original cases for those lenses. Ordering a lens directly from testing eliminates all of this inconvenience.

By using the latest technologies available, we can create loyalty among our patients, many of whom recognize the level of expertise and the advanced techniques provided. Patients also appreciate being fit with lenses that are applied to their eyes only. With the challenges associated with COVID-19 and its virus (SARS-CoV-2), which also has been identified in the tears of some patients (albeit at very low levels),¹¹ having an alternative that eliminates the need for a reusable lens is appealing.

Diagnostic Fitting During the height of the COVID-19 pandemic, there were serious concerns about office protocols and a need to limit patient contact. While the literature supported the use of contact lenses,¹² there was a legitimate concern about the safety of reusable in-office diagnostic lenses. As practices return to normal, a question remains: Is it acceptable to reuse contact lenses for fitting purposes?

This discussion does not typically apply when fitting most standard soft lenses; manufacturers supply practitioners with single-use lenses that can be discarded after every patient. There are greater concerns about other lens designs, specifically specialty soft lenses, GP lenses (including scleral lenses), and hybrid lenses. To address these concerns, a contact lens disinfection protocol was developed in cooperation with the AOA CLCS and the American Academy of Optometry Section on Cornea, Contact Lenses and Refractive Technologies.¹ This report, which was based on the 2018 recommendations from the ISO, describes a detailed cleaning process to be performed after every use of in-office diagnostic lenses and every 28 days for lenses that have been opened and not reused. This report explains what should be done with reusable GP, hybrid, and soft contact lenses. Putting this evidence-based research into practice can help practitioners feel more comfortable fitting reusable lenses.

Fitting patients with diagnostic lenses can result in fewer lens modifications and remakes. Placing a lens on the eye enables practitioners to accurately assess fitting factors such as movement and centration. A diagnostic fitting approach is the only way to evaluate this in all positions of gaze in addition to evaluating the exact relation between the lens material, design, and its interaction with the ocular surface and tear film. Empirical fitting could miss other aspects of a contact lens fitting such as lid-lens interaction and ocular surface issues. Although the first lens placed on the eye may not completely correct vision, an over-refraction can demonstrate the real visual potential. In addition, patients and practitioners may have a greater appreciation for diagnostic fitting, as there is more to the examination.

We also cannot overlook the patients’ perspective. Yes, chair time is a consideration, and the fitting should be as efficient as possible; but, it is much easier to justify a fitting fee when the examination has more components and extensively involves patients. Allowing patients to experience the fitting process can make a positive impression on their opinion of your expertise.

In the past, designing empirical lenses was challenging with certain irregular corneas, but that reality is changing. Anterior segment imaging technology has come a long way,¹³ but the cost of such diagnostic equipment makes these options unrealistic for some practitioners. Diagnostic contact lens fitting sets are less costly and are more accessible to many more practitioners.

CONTROVERSY 2: OVERNIGHT ORTHOKERATOLOGY VERSUS SOFT MULTIFOCAL CONTACT LENS WEAR FOR MYOPIA MANAGEMENT

Overnight Orthokeratology One of the more common concerns that parents have about ortho-k is its safety. Practitioners go to great lengths in their practices and as a profession to educate patients and parents on the risks of sleeping in their contact lenses. When using overnight ortho-k, we tell parents that we want to prescribe a therapy to help manage their child’s myopia by having them sleep in their contact lenses. It’s a common concern, but the research is clear that ortho-k is a safe and effective way to manage myopia.^14,15,17

With any contact lens modality, the major safety concern is microbial keratitis (MK), a rare but serious adverse event. One study was comprised of 667 children who wore either ortho-k lenses or single-vision spectacles (control).¹⁴ Researchers found no occurrences of MK, and although they found a higher incidence of nonsignificant adverse events, the dropout rate was similar to that of the controls wearing single-vision spectacles. The overall incidence of MK has been estimated at 7.7 per 10,000 years of ortho-k wear.¹⁵ This estimate puts the risk of MK for patients wearing ortho-k somewhere between daily-wear soft lenses and extended-wear soft lenses.¹⁶

A tempting conclusion could be that because daily-wear soft lenses have a slightly lower risk of MK, they should be preferred in all situations. This is simply not true, as many risky contact lens behaviors can be avoided with ortho-k use. For example, many children and parents tend to forget that soft contact lenses should not be worn while swimming, or they simply ignore the risks in favor of convenience. Convenience can become a motivating factor for other risky contact lens behaviors. Children wearing daily-wear soft lenses may find it inconvenient to wash their hands or to use proper cleaning solutions while away from home during the day; conversely, children wearing ortho-k apply their lenses at night before they go to bed and remove them in the morning upon waking, so they are almost always near their solutions, hand soap, and assistance from parents while wearing their lenses.¹⁷

Along with a good safety profile, current research suggests that axial length progression can be slowed by about 50% with ortho-k wear.^18-20 Significant reductions in axial length and in dioptric progression have been demonstrated in comparison to controls over various population groups and various time frames.^21,22 Over many decades of use, research, and improvement, ortho-k has secured its place as a safe and effective option for myopia management.

Soft Multifocal Lenses Originally prescribed for presbyopia, both aspheric (center-distance) and concentric-ring-design multifocal lenses have been prescribed for myopia management. In addition to axial length and refractive error, factors such as add power and pupil size need to be considered when prescribing lenses to manage myopia. With this background in mind, two arguments that favor the use of soft multifocal lenses for myopia management can be considered.

• Argument #1: By its very nature, ortho-k precludes knowing whether myopia management with respect to refractive error is effective. Cycloplegic refraction and axial length measurements are the standard of care for monitoring the effectiveness of myopia management with daytime-use contact lenses.²³ Because ortho-k corrects refractive error by reshaping the cornea, refractive error cannot be used as an effective treatment indicator. If the goal is to decrease refractive progression, it cannot be determined whether the progression of refractive error is being effectively controlled in patients who are being treated with ortho-k.
• Argument #2: The peripheral defocus cue responsible for reducing myopia progression is easier to control with soft multifocal lenses than with ortho-k lenses. Myopia management using contact lenses depends on creating peripheral defocus, and it makes sense to infer that higher add powers will provide better efficacy.²⁴ To examine this hypothesis, the Bifocal Lenses In Nearsighted Kids (BLINK) study randomly assigned children to wear either commercially available single-vision contact lenses or medium- (+1.50D) or high- (+2.50D) add-power soft multifocal contact lenses for three years.²⁵ This study demonstrated that treatment with high-add-power multifocal lenses reduced the rate of myopia progression more effectively compared with either the medium-add-power multifocal or the single-vision contact lenses. With custom soft lens designs, much higher add powers (e.g., +3.00D or greater) can be easily incorporated and prescribed for myopia management.

By contrast, to create greater defocus for more effective myopia management with ortho-k lenses, aspheric curves must be employed. This requires special computer software that integrates with topography to generate the requisite aspheric curves. Used correctly, this approach can be effective; however, the software, hardware, and/or training to use these may not be available to every practitioner.

CONTROVERSY 3: PRESBYOPIA-CORRECTING PHARMACEUTICALS AND CONTACT LENS WEAR

Presbyopia-Correcting Pharmaceutical Agents: A Viable Option Presbyopia is a global challenge affecting more than 1 billion people worldwide.²⁶ In addition to causing frustration for patients, presbyopia impacts task performance and productivity. Current modes of correction include spectacles, contact lenses, refractive surgery, and intraocular lens implantation. These corrections carry a financial burden of up to 34% in developed countries and up to 50% in the developing world, where there is lack of awareness of—and of access to—affordable treatment options.²⁶

While pharmaceutical options to treat presbyopia will not replace current corrective options, they will act synergistically to augment these options. For example, patients who wear multifocal contact lenses may need to wear eyeglasses over their lenses when reading small print on a medication label. Similarly, patients who use presbyopia-correcting pharmaceuticals will be able to enhance their near vision with eyeglasses when needed, so they will have freedom from eyeglasses for most of their needs most of the time.

As pharmaceutical companies focus on bringing this new presbyopia-correcting option to market, insights can be gained from these research and development efforts. For example:

• Anti-aging is big business. Presbyopia-correcting pharmaceutical agents are part of the anti-aging market—$44 million in the United States in 2020—aimed at helping people look and feel young.²⁷ Presbyopia is often the first sign of aging, and many people don’t envision themselves wearing eyeglasses for near vision.
• Patients will still use spectacles or contact lenses in addition to presbyopia-correcting pharmaceuticals. A survey asked 131 people what they would use after a certain unbranded presbyopia pharmaceutical wears off. Eighty percent of those surveyed responded that they would still use prescription eyeglasses or contact lenses in addition to the pharmaceutical.²⁸ Thus, presbyopia-correcting pharmaceuticals are additive for many patients and will supplement their current options for near vision.
• Achieving functional vision requires varying levels of improvement depending on baseline vision. The severity of presbyopia varies among individuals, but many day-to-day needs are for intermediate or mid-range vision. The terms “mild,” “moderate,” and “advanced” to classify presbyopia are directly related to the accommodative reserve of the lens and, thus, refer to lenticular dysfunction.²⁹ In other words, the baseline severity of presbyopia determines how much improvement is needed for an individual to obtain functional vision.²⁹

FDA approval of a presbyopia-correcting pharmaceutical may require the treatment to provide three lines of visual acuity improvement without reducing distance vision; however, a patient who has mild presbyopia may start with near vision of 20/40, making three lines of improvement difficult to achieve. A patient who has severe presbyopia may start with 20/100 near vision and might easily achieve three lines of improvement but still have difficulty with near vision. In a review publication of everyday social reading activities, the most common print size was approximately J5 or 20/40,³⁰ demonstrating that functional vision may be attained without reaching 20/20 near vision.

With presbyopia-correcting pharmaceuticals, a personalized management strategy for each patient can be developed, with customized options to fit their needs.

Presbyopia-Correcting Pharmaceuticals: Precautions for Multifocal Lens Wearers The sophisticated designs and technologies of current multifocal contact lenses have revolutionized the care of presbyopic patients. Through innovative advancements in lens materials, patients are offered a seamless, comfortable lens-wearing experience.

The new presbyopia-correcting pharmaceutical options are being discussed as supplementary because of their ability to enhance the performance of multifocal lenses. This is an assumption that needs to be proven before it is accepted by the professional community.

The efficacy of miotic presbyopia-correcting pharmaceuticals will depend on their ability to manipulate pupil size. They leverage the fact that a smaller pupil will increase depth of focus. By increasing depth of focus, blur is decreased, improving near acuity.

Most multifocal contact lenses are based on the premise that both distance and near optics will be focused on the retina at the same time. This is often referred to as simultaneous vision. Certain pupil diameters are required to incorporate both distance and near optics within the pupil. Miotic agents reduce pupil size and may alter the way that the intended optics in a multifocal contact lens enter the eye.

Consider a patient who is fit with a multifocal lens designed with center-near optics that slowly progress to distance optics in the lens periphery. This patient depends on an adequate pupil size to allow the distance optics to enter the eye. A pharmacologically induced miotic pupil may not provide a balance of distance and near optics for this patient. Although it may enhance near performance in the multifocal lens, there are concerns about what will happen with the distance optics that now are unable to adequately enter the pupil.

What’s more, the ocular surface in presbyopia patients tends to be different from that in non-presbyopic patients. It is well established that dry eye disease is more prevalent among patients who are older than 40 years of age. Introducing other molecules to the ocular surface, through either pharmacological agents or preservatives, may have deleterious effects on how the ocular surface produces its natural tears in a homeostatic state. Add to that the effect of placing a drop on the ocular surface every day, and it creates a challenging environment, not only for contact lens wearers but potentially for nonwearers as well. When working with presbyopic patients, it’s critical to be cognizant of these factors and of the potential issues that a presbyopia-correcting pharmaceutical option may present.

NEW OPPORTUNITIES FOR PERSONALIZED CARE

This is an exciting time in eye care as we ring in 2022. There are new guidelines for contact lens disinfection, new technologies for fitting contact lenses, new and emerging options for myopia management, and an entirely new category of pharmaceutical options for presbyopia. With all of these advancements, there is an opportunity to provide more personalized and better care for patients. CLS

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