CONTROVERSIES ABOUT CONTACT LENSES are ongoing, and the leadership of the American Optometric Association Contact Lens and Cornea Section is once again excited to provide a new series on this topic in our annual article for Contact Lens Spectrum. These controversies include: 1) On-label versus off-label treatment for myopia management; 2) Are we overprescribing scleral lenses?; and 3) Should all contact lens patients be fit into a daily disposable contact lens?
ON-LABEL VERSUS OFF-LABEL TREATMENT FOR MYOPIA MANAGEMENT
Myopia prevalence is increasing worldwide. In the absence of intervention, the global prevalence is projected to reach 50% by the year 2050.1 A concomitant increase in the prevalence of high myopia will likely lead to a rise in consequent conditions that threaten sight. This has stimulated interest in methods that slow myopia progression.
Validated therapies available in the United States include low-dose atropine, daytime soft multifocal and dual focus contact lens wear, and overnight orthokeratology. Currently, some of the aforementioned therapies are approved by the U.S. Food and Drug Administration (FDA) while others are prescribed as off-label protocols for myopia management. With this background in mind, arguments that favor either FDA-approved or off-label treatments can be made. For the didactic purposes of better understanding the benefits of both FDA-approved and off-label treatments, and for making evidence-based clinical decisions, below are arguments for using one treatment over the other.
FDA approval is important, and on-label therapies should be highly preferred over off-label. The FDA does not regulate the practice of medicine, and off-label use of therapies is common. There may not be an approved therapy available or dosage may differ from that on the label. Until recently, approved therapies for myopia were lacking. The FDA employs a rigorous evidence-based process to approve therapies that are both safe and efficacious. In the practice of medicine, favoring FDA-approved therapies maximizes benefit while minimizing risks, and such therapies often become the standard of care. Due to a general lack of studies, off-label use in pediatric populations is especially common. It is therefore fortunate that approved myopia therapies are available for use in children.
Safety is a major consideration when prescribing for children. Children may not react the same as adults and they have a long time to live with unwanted outcomes. Thus, even if there are robust data and approved therapies for adults, one may not necessarily predict with confidence the response of children. When approved therapies exist for children, they may be favored over off-label treatments. Not only is safety and efficacy evaluated up front by the FDA, but ongoing post market surveillance is also integrated into the process to uncover any rare and/or serious deleterious outcomes. This alone justifies using FDA-approved therapies over off-label uses.
When prescribing off-label treatments, the practitioner assumes a great burden of responsibility. Motivated and experienced clinicians who are familiar with the known risks and benefits of an off-label therapy are best positioned to employ such treatments effectively and safely. This requires critical evaluation of all the available data as well as an understanding of the known mechanisms of action. This knowledge, combined with anecdotal clinical experience, enables clinicians to consider the possible outcomes and weigh the risks and rewards. Off-label use is, therefore, best left to those who are specialists in a particular field.
FDA-approved treatments are also more accessible to patients. Additionally, approved pharmaceuticals and optical devices are often covered by insurance, which increases access to care. For myopia management, atropine drops may soon be available at all pharmacies, not just specialized compounding facilities. In addition, the recent approval of soft contact lenses for myopia control, and the assignment of a medical code for such usage, portends eventual insurance coverage.
Off-label therapies are appropriate and should not be devalued compared to on-label options. Although FDA approval is valued among both practitioners and patients when choosing a myopia management option for a child, some of our most effective options are considered off-label. Currently, the only FDA-approved options for myopia management are contact lenses. If practitioners confine patients to an FDA-approved option, they are severely limiting the number of patients who could potentially benefit from myopia management.
Off-label use of ophthalmic products in myopia management has broadened the scope of practice and allows for advancements in both practitioners’ knowledge and treatment options for patients. Thus, there are several arguments in favor of also incorporating off-label options into the arsenal of tools to combat progressive myopia.
First, most off-label options have been used far longer than the current FDA-approved option, and several robust clinical studies back their efficacy. The Bifocal Lenses In Nearsighted Kids (BLINK) study has validated that high-add center-distance multifocal contact lenses are effective in reducing myopic progression and slowing axial elongation in children.2 The Low Concentration Atropine for Myopia Progression (LAMP) study has shown that 0.05% is the most effective dosage of atropine and has minimal side effects and rebound effect.3 Finally, a number of studies demonstrate the effectiveness of orthokeratology in slowing myopia progression, on average, approximately 50%.4
The second argument is that off-label contact lens options include widened prescription parameters for both myopia and astigmatism, which significantly increases the number of patients who could benefit from myopia management. The currently approved options are limited to –6.00DS and –1.50DC. Thus, parents of patients who have highly myopic or astigmatic prescriptions must seek off-label alternatives to correct their children’s vision and manage their myopia progression.
Third, the cost of a product is often impacted by FDA approval, whereas a “generic” or off-label option typically costs less. Having a more cost-effective option will allow even the most budget-conscious family to have access to an affordable treatment. This is especially beneficial to families who have more than one child in need of myopia control.
Lastly, despite certain lenses and low-dose atropine being used in an off-label manner, the base products themselves are FDA-approved for ophthalmic use. Atropine 1% has been used for cycloplegia in young children, as well as in patients struggling with ocular pain and inflammation, for decades. Overnight orthokeratology designs have been approved for temporarily minimizing refractive error for 20 years. Similarly, soft center-distance multifocal lenses are FDA-approved modalities for vision correction. Thus, the safety of all of these modalities has been well established.
ARE WE OVERPRESCRIBING SCLERAL LENSES?
There are many patients who should not be fit in a scleral lens. Over at least the past decade, the prescribing of scleral lenses in clinical practice has increased. The expansion of scleral lens options, fitting sets and manufacturers, improvements in materials, and clinical education to improve fitting options have contributed positively to this trend. Additionally, the introduction of scleral profilometry technology yields better fitting options, further contributing to an increase in scleral lens utilization.
Scleral lenses have been widely accepted as an adjunct therapy for ocular surface disease. Initial comfort has decreased adaptation time for the patient, and multiple peer-reviewed publications have cited that scleral lenses have been effective in helping individuals who have corneal ectasia by expanding the ability to fit more severe cases that may have historically been referred for corneal transplantation.5-7 However, is this too much of a good thing? Are we overprescribing scleral lenses?
In 2018, the Scleral Lenses in Ophthalmic Practice: An Evaluation (SCOPE) study looked at prescribing trends for scleral lenses among eyecare providers.8 Overall, the study demonstrated that well over 70% of respondents demonstrated some level of proficiency in scleral lens fitting, while the remainder of respondents showed interest in fitting, which may portend more scleral lens fitting in the future. The two broad indications for fitting scleral lenses are corneal ectasia and ocular surface disease. However, we now have scleral lenses for “regular” corneas including high ametropia and presbyopia.
GP lenses account for approximately 10% of the overall contact lens fits within the United States.9 Scleral lens prescribing trends depend on location, with the vast majority of fits occurring in the United States, the Philippines, Sweden, and the Netherlands.10
However, scleral lenses are not without complications,11 but studies on adverse events are quite rare in the literature.12,13 Certainly, given the length of time and amount of research, corneal GP lenses have a significantly higher amount of peer-reviewed evidence to support overall long-term impact on corneal health and vision compared to scleral lenses. The wealth of unanswered questions about the long-term impact of scleral lenses on corneal and ocular health could influence one to think that practitioners might be overprescribing scleral lenses, but as always, time will tell.
Our current level of scleral lens use is appropriate, and a wide variety of patients can benefit from scleral lens wear. There are a myriad of optical and therapeutic indications for scleral lens use.14 When scleral lenses were first manufactured in GP materials during the 1980s, the most common conditions treated were high ametropia (aphakia and myopia, 44%), primary corneal ectasia (keratoconus, pellucid marginal degeneration, and keratoglobus, 32%), post-penetrating keratoplasty (12%), and ocular surface disease (7%).14-16 Now that silicone hydrogel soft contact lenses are used for the refractive correction of aphakia and high myopia, the most frequent clinical conditions treated with modern high-oxygen-permeable scleral lenses are primary corneal ectasia (53%), ocular surface disease (18%), and post-penetrating keratoplasty (17%).
Novel scleral lenses are also used for the correction of simple refractive errors, including astigmatism and presbyopia, especially when other modalities fail due to reduced vision or poor comfort.17 Even in cases of severe corneal and/or conjunctival irregularities, exposure, and nonhealing epithelial defects, scleral lenses are able to protect and lubricate the ocular surface while providing crisp and clear vision. And due to their rotational stability and minimal movement with blinking, scleral lenses are currently being used as a stable platform for a range of optical applications such as drug delivery, electrolyte sensing, augmented reality, and as a reflecting telescope.
Scleral lenses have many indications beyond the correction of irregular astigmatism and ocular surface disease. They may function as the ideal drug delivery system and as an option for incorporating augmented reality and telescopes in the lens. The future of scleral lenses is optimistic, as the number of publications, interest, and innovations continue to establish the many applications of this modality.
SHOULD ALL CONTACT LENS PATIENTS BE FIT INTO A DAILY DISPOSABLE LENS?
All contact lens patients should be fit into a daily disposable lens. Practitioners are fortunate to have a plethora of contact lens options for patients. This holds especially true as it pertains to daily disposable contact lenses. Over the last decade, there have been substantial innovations in the realm of daily disposables.
Daily disposable lenses have always been an exceptional option for a number of reasons. Compliance is higher with daily disposable lenses than with two-week or monthly disposable modalities because of the ease of remembering when to replace them—on a daily basis.18 The benefit is that they do not need to be cleaned. This removes a large compliance step. Because a new lens is used every day, surface deposits are almost a nonissue, as anything that accumulates on the lens throughout the day will be disposed of at the end of the day and not re-exposed to the ocular surface.
The fact that patients use new lenses daily has a substantial advantage for contact lens wearers who have allergic conjunctivitis.19,20 In fact, the FDA recently approved a new daily disposable lens that has ketotifen embedded within it, specifically designed for contact lens wearers who have allergic conjunctivitis.21
Some have criticized daily disposables for the waste that they produce. Fortunately, there are now multiple programs in which the lenses and blister packs can be recycled.
Another criticism of daily disposable lenses is that they are more expensive than two-week or monthly disposable lenses. Although that may be the case, when solutions that are required to care for those lenses are factored into the equation, often the cost of daily disposables is similar to that of other disposable modalities. Another cost consideration is the frequently generous rebates that are available to be used to buy daily disposable lenses. Due to all of these considerations, daily disposable lenses provide an exceptional value for patients.
In recent years, silicone hydrogel daily disposable lenses have been introduced by all of the major contact lens manufacturers. Spherical, toric, and multifocal options are available to meet the visual needs of the majority of patients. With everything taken into consideration, why wouldn’t everyone be in a daily disposable lens?
Not all contact lens patients should be fit into a daily disposable lens. Daily disposable contact lenses are a great tool for practitioners, but should all patients be in this modality? While the benefits abound, let’s look at some of their limitations and drawbacks.
The most obvious reason to avoid a daily disposable lens is if the patient falls outside of the available parameters for this modality. Too often, when patients fall into the gray areas of these parameters, practitioners compromise to keep them in daily disposable lenses. An eyecare practitioner may under-correct the astigmatism in a hyperope who has –2.75D refractive cylinder to keep the patient in a daily disposable. Or maybe we fit a low toric patient in a lens that is 10º off when an oblique axis is not available. Wouldn’t these patients be better off wearing a planned replacement lens in the correct parameter?
On the same note, many astigmatic presbyopes are fit with monovision in order to use a daily disposable. While monovision can be successful, most patients prefer multifocals,22,23 and the binocularity offered with multifocals is sufficiently important that the Federal Aviation Administration will not allow airline pilots to wear monovision while flying.24
There may also be certain features, such as photochromic lens technology, from which patients could benefit but that are not available in a daily disposable modality. Or perhaps the patient’s keratometry and horizontal visible iris diameter (HVID) are outside the normal distribution and a daily disposable lens would not fit properly. Lens parameters and features are constantly expanding in the daily disposable market, and maximizing the patient’s vision and ocular health should warrant a fit into an appropriate reusable lens.
Typically, when making a compromise in lens parameters to put a patient into a daily disposable lens, practitioners cite comfort and safety concerns as justification. Recent research has shown similar de-wetting properties when comparing daily disposable to planned replacement contact lenses.25
As it pertains to safety, many of the adverse events related to reusable lens wear can be eliminated with proper care and handling.26 The importance of training both new and existing patients on this cannot be overstated. When properly cared for, reusable lenses have similar safety profiles.27 The first daily disposable contact lenses were introduced almost 30 years ago, yet over that same period the rate of microbial keratitis (MK) has remained unchanged, and there is no consistent evidence that they have impacted the overall rate of MK at all.27-30
CHANGE IS CONSTANT
Every year there is controversy surrounding change, and 2023 will be no exception. The options, availability, and standards involved in clinical practice are continuously evolving. As these changes occur, eye-care practitioners need to stay at the forefront of the discussion and lead the way to better vision, function, and outcomes for the patients that we serve. CLS
- Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123:1036-1042.
- Walline JJ, Gaume Giannoni A, Sinnott LT, et al; BLINK Study Group. A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods. Optom Vis Sci. 2017 Sep;94:856-866.
- Yam JC, Jiang Y, Tang SM, et al. Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control. Ophthalmology. 2019 Jan;126:113-124.
- Lee YC, Wang JH, Chiu CJ. Effect of Orthokeratology on myopia progression: twelve-year results of a retrospective cohort study. BMC Ophthalmol. 2017 Dec 8;17:243.
- DeLoss KS, Fatteh NH, Hood CT. Prosthetic Replacement of the Ocular Surface Ecosystem (PROSE) Scleral Device Compared to Keratoplasty for the Treatment of Corneal Ectasia. Am J Ophthalmol. 2014 Nov;158:974-982.
- Koppen C, Kreps EO, Anthonissen L, Van Hoey M, Dhubhghaill SN, Vermeulen L. Scleral Lenses Reduce the Need for Corneal Transplants in Severe Keratoconus. Am J Ophthalmol. 2018 Jan;185:43-47.
- Ling JJ, Mian SI, Stein JD, Rahman M, Poliskey J, Woodward MA. Impact of Scleral Contact Lens Use on the Rate of Corneal Transplantation for Keratoconus. Cornea. 2021 Jan;40:39-42.
- Schornack MM. Scleral Lenses: A Literature Review. Eye Contact Lens. 2015 Jan;41:3-11.
- Morgan P, Woods C, Tranoudis J, et al. International Contact Lens Prescribing In 2021. Contact Lens Spectrum. 2022 Jan;37:32-38.
- Nichols JJ, Starcher L. Contact Lenses 2021. Contact Lens Spectrum. 2022 Jan;37:22-24,26,28,29.
- Carrasquillo K, Lipson M, Ezekiel D, Johns L, Barnett M. Scleral Lens Complications and Problem Solving. In Barnett M, Johns LK, eds. Contemporary Scleral Lenses Theory and Application. Bentham. 2017:303-354.
- Walker MK, Bergmanson JP, Miller WL, Marsack JD, Johnson LA. Complications and fitting challenges associated with scleral contact lenses: A review. Cont Lens Anterior Eye. 2016 Apr;39:88-96.
- Fadel D. Scleral Lens Issues and Complications Related to a Non-optimal Fitting Relationship Between the Lens and Ocular Surface. Eye Contact Lens. 2019 May;45:152-163.
- Barnett M, Courey C, Fadel D, et al. CLEAR – Scleral lenses. Cont Lens Anterior Eye. 2021 Apr;44:270-288.
- Ezekiel D. Gas permeable haptic lenses. J Br Contact Lens Assoc. 1983 Oct;6:158-161.
- Pullum K, Trodd T. The modern concept of scleral lens practice. J Br Contact Lens Assoc. 1984 Jul;7:169-178.
- Segal O, Barkana Y, Hourovitz D, et al. Scleral contact lenses may help where other modalities fail. Cornea. 2003 May;22:308-310.
- Rueff EM, Wolfe J, Bailey MD. A study of contact lens compliance in a non-clinical setting. Cont Lens Anterior Eye. 2019 Oct;42:557-561.
- Solomon A. Allergic manifestations of contact lens wearing. Curr Opin Allergy Clin Immunol. 2016 Oct;16:492-7.
- Bielory L. Ocular allergy treatment. Immunol Allergy Clin North Am. 2008 Feb;28:189-224.
- Pall B, Gomes P, Yi F, Torkildsen G. Management of Ocular Allergy Itch With an Antihistamine-Releasing Contact Lens. Cornea. 2019 Jun;38:713-717.
- Rajagopalan AS, Bennett ES, Lakshminarayan V. Visual performance of subjects wearing presbyopic contact lenses. Optom Vis Sci. 2006 Aug;83:611-615.
- Gupta N, Naroo SA, Wolffsohn JS. Visual comparison of multifocal contact lens to monovision. Optom Vis Sci. 2009 Feb;86:E98-E105.
- Federal Aviation Administration. Guide for Aviation Medical Examiners. Available at faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/app_process/app_history/item17b . Accessed Nov. 14, 2022.
- Havuz E, Gokmen O. In-vitro dewetting properties of planned replacement and daily disposable silicone hydrogel contact lenses. Cont Lens Anterior Eye. 2021 Oct;44:101377.
- Dumbleton KA, Woods CA, Jones LW, Fonn D. The relationship between compliance with lens replacement and contact lens-related problems in silicone hydrogel wearers. Cont Lens Anterior Eye. 2011 Oct;34:216-22.
- Szczotka-Flynn LB, Shovlin JP, Schnider CM, et al. American Academy of Optometry Microbial Keratitis Think Tank. Optom Vis Sci. 2021 Mar 1;98:182-198.
- Stapleton F, Keay L, Naduvilath T, et al. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115:1655-1662.
- Dart JK, Radford CF, Minassian D, Verma S, Stapleton F. Risk factors for microbial keratitis with contemporary contact lenses: a case-control study. Ophthalmology. 2008 Oct;115:1647-1654.
- Morgan PB, Efron N, Hill EA, Raynor MK, Whiting MA, Tullo AB. Incidence of keratitis of varying severity among contact lens wearers. Br J Ophthalmol. 2005 Apr;89:430-436.