OCULAR SURFACE DISEASE AND CONTACT LENSES: AN ADDITIONAL EFFECTIVE STRATEGY IN TREATMENT.

Dry eye is a highly prevalent condition, and ranges from approximately 7% to 34%.1-2 In the United States, an estimated 23 million people age 20 and older report dry eye disease of any severity.3 Dry eye disease is a condition where there are not enough tears or poor quality of tears to lubricate and nourish the eye. Tears maintain the health of the front surface of the eye and provide good vision. Dry eye disease is a common and often chronic problem, particularly in older adults. Advanced dry eyes may damage the front surface of the eye and impair vision.

Many different factors cause dry eye. Dry eye disease is more common in people 50 years old or older.4 Hormonal changes, especially common in women, can cause dry eye. 6-8. Other conditions that can exacerbate dry eye symptoms include diabetes, glaucoma, Sjögren’s disease, lupus and rheumatoid arthritis. Medications can also cause symptoms of dry eye, including antihistamines, hormonal replacement therapy and androgen therapy. Environmental factors such as pollen or allergies, working on the computer, an overhead ceiling fan or contact lens wear can worsen dry eye. 9

While dry eye is perhaps the most prevalent ocular surface disease condition we encounter, numerous other conditions affect the quality of the ocular surface, disrupting patient comfort, vision and quality of life. Ocular surface disease can occur with irregularities in the orbital muscles, eyelids, conjunctiva, and corneal layers.10  When the orbital or eyelid muscles are affected by injury, stroke, or other neurologic palsies, the patient’s blink pattern will be inhibited or altered, changing the way tears are spread across the ocular surface.11 Patients suffering from these conditions experience a significant decrease in comfort due to desiccation, relying heavily on a combination of topical gels, ointments, topical medications including cyclosporine and steroids, punctual occlusion, eye shields, autologous serum tears and over-the-counter artificial tears to provide protection and pain relief.12 Similar to the muscular conditions affecting the tears spreading across the ocular surface, changes in the eyelid margin structure from surgery, trauma or inflammation can affect the ocular surface and production of tears. Within the eyelids, there are numerous glands that contribute to tear production and stability, and these glands are affected by the environment, use of systemic medications, and overall nutrition.13 One of the main contributing glands to the tear layer are the meibomian glands, and current research highly supports the treatment of meibomian gland dysfunction as a first line treatment for dry eye conditions. According to the International workshop meibomian gland dysfunction (MGD) report, MGD “may well be the leading cause of dry eye disease throughout the world.”13 MGD can lead to an altered tear film, which then causes eye irritation and clinically apparent inflammation and ocular surface disease. It is critical to have a healthy, functional tear film, and clean eyelids with intact meibomian glands are imperative. Meibomian glands provide a smooth optical surface for the cornea at the air-lipid interface. By enhancing the stability, thus creating a more smooth and even tear film, well functioning meibomian glands provide a healthy ocular surface. This healthy ocular surface can improve vision and ocular comfort, especially in contact lens wearers.  A recent study reported that 86% of patients evaluated had some degree of meibomian gland dysfunction, and that the number of patients exhibiting only meibomian gland dysfunction (n=79) was over three times more than the number of patients exhibiting only aqueous deficient dry eye (n=23).14

Dry eye may have multiple presentations and can range from mild to moderate to severe. Dry eye symptoms include the feeling of dryness, pain, stinging, burning, Itchy eyes, sandy, gritty or foreign body sensation, photophobia, excessive tearing and blurry or interrupted vision. In all forms of dry eye, especially in the severe ocular surface disease population including Sjogren’s disease, graft versus host disease (GVHD), Stevens-Johnson syndrome or limbal stem cell deficiencies, scleral lenses are an option to alleviate symptoms of dry eye that may be debilitating.15

Dry eye disease can be diagnosed in many different ways. Corneal staining and tear film break up time were among some of the first objective findings to document dry eye. Assessing tear production, osmolarity, and other components of the tear film became new strategies in further evaluating the ocular surface. New computerized technology has given practitioners the ability to diagnose dry eye disease at a high level by evaluating the entire ocular surface, tear film, and meibomian glands.16-21  

There are many ways to manage dry eye disease. Patients spend 3.8 billion dollars per year in the United States on symptom relief.21 Treatments vary from simple over-the-counter remedies to invasive surgeries. Simple options include over the counter artificial tears and gels (either non-preserved or preserved). Patients experiencing decreased tear production may benefit from collagen (temporary) or silicon (permanent) punctal plugs to help the quantity of tears to stay on the eye longer.  Patients suffering from a decreased lacrimal lake, decreased lacrimal function, or keratoconjunctivitis sicca usually benefit the most from this treatment. Patients who experience relief from punctal plugs may opt for a more permanent treatment in which the puncta are permanently sealed with laser cauterization. 22-23

Eyelid hygiene can include eyelid scrubs or foams that are used on a daily basis.  Warm compresses, be it via warm cloths or a variety of commercial products, are available to provide heat to the eyelids, which loosen potentially clogged meibomian glands, enabling a healthy ocular surface. Apply warm compresses, including commercial products, from five to 10 minutes daily. Afterward, gently move a cotton swab across the eyelid margins five to 10 times as a means of scrubbing and, therefore, removing any debris that may be blocking the meibomian glands. Removing eye makeup expedites clean eyelids and creates a healthy tear film. Describing the importance of clean eyelids, especially meibomian glands, enhances the ocular surface. In addition, review the inflammatory role of allergies and dry eye and the importance of treating all conditions. 

Dietary supplements such as omega-3 fatty acids are shown to help improve meibomian gland production/quality, and improve patient symptoms.24 Specifically, omega-3s that contain gamma-linolenic acid are very effective against MGD.25 Additionally, consider prescribing topical emollient lubricant or liposomal spray, topical azithromycin and oral tetracycline derivatives.26-27 Patients with severe dry eye may benefit from night-time moisture goggles or daytime moisture release eyewear to prevent the tears from evaporating as quickly. 

Prescription eyedrops such as Restasis (cyclosporine 0.05%) and Xiidra (lifitegrast 5%) may be of some benefit to certain patients.28-33 Other in office procedures aimed to improve meibomian gland function include BlephEx,® EyeExpress, LipiFlow, MiboFlow and IPL (intense pulse light treatment). 

The BlephEx® instrument (Rysurg) is a treatment for blepharitis and MGD. BlephEx removes debris accumulation on the eyelids due to excess bacteria, biofilm and bacterial toxins.34 The BlephEx® hand piece is used to remove scurf and debris and exfoliates the eyelids by using a medical grade micro-sponge applied along the eyelids. BlephEx takes approximately 6-8 minutes. 

LipiFlow (Tear Science) is a thermal pulsation treatment to express, evacuate and liquefy the meibomian glands. LipiFlow uses heat applied to both the inner upper and lower palpebral conjunctival eyelid surfaces and pulsatile pressure to the upper and lower outer eyelids. LipiFlow takes approximately 12 minutes per eye and has been found to be equal in efficacy to three months of twice daily warm compresses in clinical trials. (35 Zhao)

The MiboFlow Thermoflow (MiBo Medical Systems) applies consistent heat with a temperature of 108 degrees F (± 3%) to the external eyelid surface with a thermoelectric heat pump. A dual eye pad transfers heat via applied ultrasound gel to the external surface of the eyelids. Heat is used to liquefy obstructed meibomian glands. MiboFlow Thermoflow takes 10-12 minutes per eye. 36

Intense pulsed light (IPL) was originally used by dermatologists to treat rosacea. IPL operates like a heat lamp and is now used on the eyelids for patients with MGD. 37

The EyeExpress device is a medical / therapeutic unit created as a goggle based, 100% hands free device, which maintains a (controlled/constant) temperature of 110 degrees.38 The goggles are connected to a control unit (box) that which operates at 24 volts (making it safe for all patients, including those with medical implanted devices). The unit is FDA cleared as a Class 1 (510K exempt) device.38 The EyeExpress goggle system can be used wet or dry to provide different types of therapy. It treats both eye simultaneously, and there is no risk of burning the patient or corneal warpage due to misuse. This treatment helps to liquefy the meibum and express the upper and lower meibomian glands. 38

Scleral lenses are advantageous to protect and lubricate the ocular surface. The liquid layer between the posterior surface of the scleral lens and the anterior portion of the cornea acts as a tear reservoir. This layer bathes the cornea during the day while the patient wears the scleral lens. This tear reservoir can improve patient comfort and symptoms of dry eye dramatically. The scleral lens also serves as a barrier between the ocular surface and the outside environment, which can aid in protecting the eye. 

The use of scleral lenses to manage ocular surface disease was reported prior to the introduction of rigid gas permeable lenses. In 1943, Klein described the use of scleral shells fabricated from impression molds of the ocular surface in the management of exposure and neuropathic keratitis.39 In 1967, Gould described the use of flush-fitting scleral shells for management of the neuropathic keratitis.40 Gould later reported on scleral lens utilization in the management of 66 patients with dry eye conditions. 41 Scleral lenses for the treatment of corneal exposure secondary to thermal burns was reported by Constable in 1970. 42

Several papers reported the use of scleral lenses manufactured with rigid gas permeable materials for ocular surface disease. 43,44,45 More recently, scleral lenses have been reported to improve corneal epithelial integrity, vision-related quality of life, and visual acuity in patients with ocular surface disease. 46,47

Scleral lenses may benefit the following patients:

Sjogren’s Disease

Stevens-Johnson syndrome

Neurotrophic keratopathy

Lacrimal gland insufficiency/dysfunction

Scleroderma

Cancer/chemotherapy patients

Unresolving keratitis

Bullous keratopahy

Recurrent corneal erosion

In a Mayo clinic study published in 2014, therapeutic relief from scleral lenses was achieved in all but two of the 115 patients that completed the scleral lens fitting process.48 Most common conditions treated in the study included undifferentiated ocular surface disease, exposure keratophy and neurotrophic keratopathy. Patients had tried an average of 3.2 forms of other forms of intervention to treat their conditions prior to finding relief with scleral lens wear.48 Another study found that 86% of patients reported an improvement in their quality of life due to the improved vision and decrease in ocular discomfort while wearing their scleral lenses.49

In these advanced dry eye cases, visual rehabilitation may not be the goal. In some instances, improvement of vision is obtainable. In severe dry eye cases, healing the ocular surface and preventing further damage is the goal. 

In clinical practice, it is helpful to document the goal of scleral lens therapy and continuously educate our patients regarding visual expectations. Outlining the subjective and objective findings can be helpful in creating a treatment plan. Subjective findings include case history along with symptoms and detailed complaints of the patient. Several dry eye questionnaires are available, and many can be administered while the patient is waiting or via a technician. Objective findings include tear meniscus height, non invasive tear break up time (with and without fluorescein), corneal/conjunctival staining, tear osmolarity, presence of inflammation, anterior segment photos, meibomian gland expression, and meibography. Both subjective and objective findings give the practitioner valuable information about the particular patient case and can lead to a customized treatment plan. 

Scleral lenses may also not eliminate the need for adjunctive therapy such as topical steroids, autologous serum or artificial tears. 50  Patients with dry eye syndrome are often times looking for a cure, but it is critical to explain to patients that dry eye disease is a chronic disease. This disease requires constant management and explaining the treatment plan and prognosis early in the disease can prevent future frustrations and confusion. Dry eye treatments may change over time, as patients age, and this projection should be outlined as well.  Educating our patients, their families and our staff of the need for adjunctive therapy has been beneficial in our practices. 

Scleral lenses are now easier to fit than ever. Manufacturers have developed detailed fitting guides and many have created webinars, wet labs, and online support to assist practitioners with fitting their designs. Once a fitting set is obtained, simply following the fitting guide will yield an acceptable starting point for a scleral lens fit. Ordering scleral lenses can be done through telephone, email, fax, or online portals, and lab consultants are eager to assist with any questions. Other resources practitioners may find helpful include the Gas Permeable Lens Institute and the Scleral Lens Society. Both of these non affiliated organizations provide practitioners with useful tools such as calculators, peer reviewed literature, frequently asked questions and answers, free webinars, along with the option to ask an expert. 

Dry eye patients may have more complications with scleral lenses, due to their compromised ocular surface. One of the most frustrating findings includes non-wettability of the surface of the lenses. Usually the patient will describe their lens fogginess to be quickly after inserting the lenses. In other cases, the foggy vision worsens throughout the day. Educating the patient on proper lens care is crucial to their success with scleral lenses. Patients should be taught how to effectively clean, disinfect, and store their lenses. This can be accomplished with a gas permeable multipurpose solution or other care system created specifically for GP lenses or a hydrogen peroxide based system. In some cases when protein and lipid deposits are extremely stubborn, a heavy duty cleaner such as Menicon Progent or other enzymatic cleaner may be necessary to remove all deposits. If the patient is compliant with their treatment regimen, and their lens surface will not wet, consider a new treatment option (FDA approval pending) such as HydraPEG. HydraPEG is a 90% water polyethylene glycol based polymer mixture that is covalently (permanently) bound to the surface of the contact lens. Lenses treated with HydraPEG result in a surface with optimal wettability, lubricity, tear film stability, and resistance to deposits. Good candidates for HydraPEG include GP patients who produce a heavy amount of deposits, patients experiencing dry eye or discomfort with their current lenses, and scleral lens patients who experience lens fogging. 51

Patients experience tear chamber debris (debris in the tear reservoir between the scleral lens and cornea) may complain that their vision gets foggy after wearing the lenses for a few hours. A typical patient will describe their vision as very clear upon insertion of the lenses, and a gradual decrease in their vision a few hours later. Many of these patients remove, rinse, and re-insert their lenses to see clearly throughout the day. Several tips are recommended for these patients. A patient with this condition should be encouraged to rinse their eye with non- preserved saline prior to insertion. This can help remove loose corneal/conjunctival epithelium, lipids, proteins, and mucins that may be contributory to the tear film debris. Also, filling the scleral lens with a more viscous solution such as Celluvisc, refresh Ooptive preservative free tears, and Oasis preservative free tears can help improve scleral lens fogging dramatically. One last option is to have the patient squirt non-preserved saline underneath the edge of their scleral lens (with the lens still on the eye) at an angle to flush out the debris. 

Scleral lens fogging and non-wettability are common sources of frustration for both practitioners and patients. If a patient has a poor tear film and/or meibomian gland function, this condition should be treated aggressively before any improvements to their scleral lenses can be expected. Patient education on ocular surface disease is important at this point because the patient can become unmotivated. Treating the underlying problem of their dry eye disease will yield the best outcome for lens surface wettability.  

With the evolution of scleral lenses, we can now offer scleral lenses to our patients with refractive error and dry eye. Scleral lenses are known to be a treatment option for highly irregular corneas, but manufacturers have developed great lens designs for all different types of eyes. Evolving contemporary scleral lens technologies   have created various innovative designs .for these different corneal shapes. These include designs that are available for patients with normal corneas and regular astigmatism. These patients are now great candidates, especially when their visual needs exceed standard soft lens parameters. Patients with high astigmatism, refractive error, post-refractive surgery (LASIK, PRK, and RK), along with presbyopia and mild to moderate dry eye are all candidates for scleral lenses.52 In our experience, patients with all three (astigmatism, presbyopia and dry eye) are thrilled with scleral lenses.