EVERY YEAR, the American Optometric Association (AOA) Contact Lens & Cornea Section contributes an article on contemporary controversies in contact lenses and anterior segment care. In this article, we will discuss scleral filling solutions and controversies pertaining to U.S. Food and Drug Administration (FDA) approval, new technological advances for dry eye care, and presbyopia correction options.
FDA APPROVAL IS ESSENTIAL WHEN CHOOSING A CONTACT LENS FILLING SOLUTION
In general, many eyecare providers err on the side of caution and opt for FDA-approved (or cleared for medical devices) medications, products, and procedures. However, the timeline to obtain FDA approval can be lengthy and costly. Thus, some providers may opt for “off-label” options.
The steps included in the process are discovery and concept, preclinical research, clinical trials, FDA review process, and sometimes, post-market safety monitoring by the FDA. Approval by the FDA means that a drug (for example) has undergone rigorous testing, and it has been determined that the benefits clearly outweigh any potential risks, including its safety and efficacy.1 Of note, the over-the-counter approval process is less rigorous than the one for prescribed medications.2
Currently, there are four solutions that have been cleared by the FDA for filling and rinsing scleral contact lenses, and all are packaged in sterile single-use vials, which means that reuse is not intended. All of these options are preservative-free solutions, thus they are less likely to have a negative impact on the ocular surface.3-6
With this in mind, eyecare providers can recommend these care solutions with minimal risk as they have been cleared via the FDA process. As we know that pH changes can cause detrimental effects on the eye, it is also helpful to know there are FDA-approved products that are similar to the eyes’ natural pH of approximately 7.4. Knowing this information can put both eyecare providers and patients at ease that these solutions are tolerated by the eye, as most of these solutions interact with the ocular surface during the course of wearing time of scleral lenses.
EMBRACING NEW TECHNOLOGY
A 2022 study out of Japan reports an abysmal 10% adherence to the manufacturer’s dosing schedule for artificial tears, despite the fact that patients who took their drops on a fixed schedule had a statistically greater reduction in symptoms.7A 2023 study reports that more than half of dry eye prescribed patients discontinue within a year.8 Similarly, it reports 66% of glaucoma patient are unintentionally failing to adhere to regimens.8 Reasons for lack of adherence include difficulty instilling drops, failing to carry drops outside of the home, feeling like the dosing schedule was too much or the amount of medicine was too much, or simply forgetting about the drops and only taking them when they felt they needed them.7,8
There is clearly a disconnect in what patients need to improve and their ability to adhere to our regimens. Therefore, it may be time to go the way of glaucoma therapies and intervene with advanced therapeutic options earlier to provide better patient outcomes that are more patient friendly.
Intense pulsed light (IPL) treatments have been proven effective in the management of dry eye as evidenced by a 2021 FDA approval.9 IPL has been shown to decrease Demodex populations, shrink telangiectatic vessels, and increase anti-inflammatory cytokines while also reducing pro-inflammatory mediators like IL-6, TNF-α, and MMP-9.10-18 These studies report improved signs and symptoms of dryness and meibomian gland disease. There are several techniques recommended as well as multiple off-label devices that can be used in office to improve patient outcomes.
Low-level light therapy (LLLT) is also gaining traction in the treatment of dry eye. LLLT has the benefit over IPL of being able to treat all skin types.19 Studies suggest that the mechanism of action is photomodulation, which brings anti-inflammatory cytokines into the tissues while also warming the meibomian glands.19-21 LLLT also improves tear breakup time.22 Together LLLT and IPL may even provide additional advantages over each one separately.23 There are even developments underway for at-home weekly LLLT treatments that show promise.24
Meibomian gland expression (MGX) techniques include manual, compressive, and hydraulic options to improve the flow of meibum. Expression has been shown to reduce inflammation and improve symptoms of dryness.25 Numerous devices are now available on the market. MGX can also be combined with the previously discussed light therapies with potential for even better outcomes.11,26
The more traditional use of punctal plugs also continues to play a role in the management of patients suffering with dry eye.27-29 In the absence of inflammation, plugs are particularly beneficial as they reduce reliance on artificial tears by keeping the patient’s own tears on the ocular surface longer.14,30
As discussed earlier, both LLLT and IPL have anti-inflammatory effects on the ocular surface. Thus, suggesting light therapies may provide another opportunity to reduce inflammation prior to the insertion of punctal plugs or perhaps even during punctal plug use when flares occur. This may provide an alternative to steroid drops for patients for whom the risks outweigh the benefits of using steroids.
Today’s options for the management of dry eye continue to evolve and provide alternatives to traditional drop regimens. These advanced therapeutic options can provide relief of symptoms and reduction in signs without the burden of frequent drops on daily life.
PRINCIPALS FOR MANAGING DRY EYE DISEASE
Keeping it simple when discussing dry eye means diagnostically understanding what we believe to be the root cause of what is causing the dry eye and then treating appropriately. We may be inadvertently rushing to more advanced procedures than may be needed. Often these advanced procedures are not covered by insurance and require both time and effort from clinicians and patients.
When we look back to the Tear Film & Ocular Surface Society Dry Eye Workshop II Report (TFOS DEWS II), there is a clearly laid out staged management and treatment recommendation for dry eye disease management.27 Education about the condition and modification of a patient’s environment are the first two recommended steps.
Understanding the patient’s current medications and if there are known offending pharmaceuticals that may be causing dry eye should result in potentially discussing it with the patient’s prescribing physician to determine if any modifications should be made. Appropriate nutritional recommendations, including dietary essential fatty acid supplementation, are also important.
Ocular lubrication through preservative-free tear supplementation is also easily accessible at a low cost for patients. Additionally, lid hygiene with either lid scrubs or hypochlorous spray along with daily warm compresses may be beneficial for patients. All of these treatments can be performed relatively easily at a low cost to the patient.
Although procedures are available to help patients, it is important to make sure that recommendations for the above suggested treatments are initially attempted. It may be sufficient to help patients with their dry eye and avoid more extensive treatments.
OPTIONS TO CONSIDER PRIOR TO PHARMACEUTICALS
First, many practitioners are familiar with traditional presbyopia options, partly because conventional presbyopia correction options are tried and tested. They have a long history of success and are trusted by millions worldwide. They have been refined over the years, so our patients can be sure they receive a high-quality product when they opt for traditional presbyopia correction options.
Companies are investing heavily in research and development to improve these methods, and they have a long history of success.31 While no treatment option is perfect, traditional presbyopia correction options are accessible, affordable, and reliable, making them attractive to millions of people worldwide.
While surgical options may sound intimidating, they are generally safe and effective, with high patient satisfaction rates. In fact, technological advances have made presbyopic surgical treatments more precise and reliable than ever before.32
However, nonsurgical options such as soft multifocal contact lens designs and technologies have substantially improved designs over the last several years. The most significant advantage of nonsurgical and surgical presbyopia treatments is their ability to be tailored to each patient’s needs. With so many options available, patients can work with their eyecare provider to choose the treatment best suited to their lifestyle, preferences, and vision goals. This personalized approach leads to better patient outcomes and greater patient satisfaction overall.
Patients also benefit from the increased parameter ranges of presbyopic nonsurgical and surgical treatment options, which continue to expand, providing patients with more choices than ever before. From traditional reading glasses to advanced surgical procedures, treatment options are available to fit every lifestyle and vision need. As technology continues to improve, we can expect to see even more innovative treatments on the horizon, making presbyopia an increasingly manageable and treatable condition.
We are often excited about the newest alternatives to treat familiar conditions, but can we really say that pharmaceutical presbyopia correction should be used as a primary treatment option? Pharmaceutical presbyopia correction options show great promise, but there are still many unanswered questions.
For example, there is a fair amount of cost for these treatments. As with any new treatment correction option, it will be expensive at first. This could limit access for many patients, especially those uninsured or underinsured. As more companies develop treatments and competition increases, the cost of these treatments may come down over time.33
PRESBYOPIC CONTACT LENS OPTIONS ARE NOT IDEAL FOR MANY
Most presbyopic contact lenses are based on the principle of simultaneous vision. Most designs have their near optics in the center of the lens and progress to the distance optics as you move away from the center of the lens. Based on the lens design, there is varying portions that are devoted to either distance, intermediate, or near.
As its name implies, in a simultaneous vision design presbyopic lens, the optics are divided between distance and near. As such, the optical signal strength at each distance is reduced compared to its single-vision counterpart. Additionally, a positive angle kappa can make centering the optics of the lens over the line of sight difficult. The aging natural lens inside the eye also changes and becomes cloudy reducing light entering the eye. For these reasons, multifocal contact lenses may not visually be the best option.
Single-vision distance contact lenses are an option with reading glasses or monovision with contact lenses to minimize the need for glasses. These two options preserve the optical purity through each eye without the compromise of simultaneous vision. Additionally, for patients who have difficulties with either of these options, there is the option of correcting the near vision with pharmaceuticals.
CONCLUSION
There are many different approaches to contact lenses and treating ocular surface disease.With that said, this feature has covered the advantages and disadvantages of the various treatments where controversies may exist. Understanding the full picture provides eyecare professionals with clinical perspectives that will ideally provide the information to make the best clinical decisions possible. CLS
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