Cornea
June 2022
by Ellen Stodola
Editorial Co-Director
Scleral lenses are an option that many physicians use to help patients suffering from more severe and advanced cases of dry eye disease. Shahzad Mian, MD, and Deborah Jacobs, MD, discussed the options and how these fit into the treatment of dry eye.
Any scleral lens can be a therapeutic lens, Dr. Jacobs said. There must be adequate oxygen transmission and some tear exchange. Typically, this requires a scleral lens that is more than 2 mm larger than the cornea diameter for 360 degrees, she explained.
Smaller scleral lenses, sometimes called mini-scleral lenses, seal onto the ocular surface and may create a mechanical challenge to what may already be a compromised epithelial tight junction in ocular surface disease, Dr. Jacobs said. “Any commercially available scleral lens, if it is fit with appropriate attention to tear exchange and oxygen transmission, can be a therapeutic scleral lens,” she said. “There are highly customized scleral lenses, such as the PROSE [prosthetic replacement of the ocular surface ecosystem, BostonSight] or EyePrintPRO [EyePrint Prosthetics], that may be necessary for eyes with unusual contours.”
There are many different types of scleral lenses available. The PROSE is the gold standard of scleral lenses for dry eye disease, Dr. Mian said. This option was the first scleral lens approved for this indication and has been available for about 2 decades.
When the PROSE was first introduced, it was revolutionary in helping patients with no other options to improve vision or comfort associated with severe dry eye disease, Dr. Mian said. “We primarily used it in patients with severe diseases—Stevens-Johnson syndrome, ocular cicatricial pemphigoid—where there were no other options. Then we started seeing a lot of patients with graft-versus-host disease,” he said. “Those patients are often the ones with severe disease who can’t function well; our standard treatments won’t work, and the PROSE is a great option.”
One issue initially was that the PROSE lens was only available in Boston, so patients would have to be sent there for a fitting. That limited access to only those who could go to Boston and stay there for a few days, Dr. Mian said. It wasn’t practical for a lot of patients. Around 2009, the Boston group that developed the PROSE decided to expand access to certain centers of excellence around the U.S., with one location being the University of Michigan, where Dr. Mian practices. “That allowed us to have a faculty member in our department trained and start doing fitting locally, and it improved access for patients around the country and revolutionized how the clinic managed severe dry eye disease with scleral lenses,” he said.
Since then, Dr. Mian said a lot of other companies have come out with scleral lenses. The main difference is the PROSE is customized and has a lot of parameters that you can choose to fit patients with, so the very difficult patients still benefit from the custom PROSE devices.
However, he said that other scleral lens options are good for those who don’t necessarily need such a customized option. “We have trial sets, so we can try different ones, and often one is good enough for a lot of these patients.” Dr. Mian added that the lenses often come at a much lower cost than a customized option. That has allowed the market to expand. The vast majority of patients can be fit into commercially available trial sets of scleral lenses. Additionally, Dr. Mian said BostonSight now makes a commercially available lens that is fit by trial set. Different sized lenses allow physicians to manage other corneal conditions—like keratoconus, corneal irregularities, LSCD—in addition to dry eye disease.
How they work
Scleral lenses work because they vault over the cornea and you can fill them with fluid, Dr. Mian said. “When it’s sitting on the surface of the eye, it’s bathing the corneal surface with fluid, so it’s helping manage the dryness by always keeping a ‘tear film’ over the surface of the eye. Also, it’s mechanically protecting the surface of the eye as a lot of issues that occur in severe dry eye patients are because of the lids constantly rubbing against the surface that’s dry and causing pain and discomfort,” Dr. Mian said.
Dr. Jacobs also stressed how these lenses create an improved environment for the ocular surface, bathing the corneal epithelium in artificial tears that are used to fill the reservoir and shielding the ocular surface from evaporation and mechanical disturbance from the lids.
They are typically a later treatment, in keeping with the DEWS II report, she said. “Typically, these are only considered after failure or insufficient response from the use of lubricant drops, gels, ointments, punctal occlusion, and treatment of the lids.”
Dr. Mian also discussed how these lenses are usually an option reserved for patients with more severe dry eye disease. They are not for those with mild to moderate disease because it is a burden in the sense that patients must invest time and money into fitting, daily insertion and removal, and disinfecting and filling solutions. “It’s not for any dry eye patient; it’s for those who have more severe disease, or they have other ocular conditions and dry eye.” For mild dry eye disease, Dr. Mian suggested using treatments like artificial tears, punctal plugs, and prescription medications.
According to Dr. Jacobs, there is good data that scleral lenses improve the ocular surface and quality of life in patients with ocular surface disease in the setting of chronic graft-versus-host disease and chronic Stevens-Johnson syndrome. Patients with exposure keratitis, be it anatomic or paralytic, also do well with scleral lenses since their lids can’t protect the ocular surface adequately, she said.
She added that scleral lenses can be useful in neuropathic pain because they can reduce nociceptive signaling related to evaporation from the ocular surface. Many neuropathic pain patients also require concurrent systemic treatment to reduce hypersensitivity to the presence of the lenses and to reduce central sensitization.
“Scleral lenses are game changers for corneal ectasia,” Dr. Jacobs said. “It is clear from reports from around the world that they reduce the need for penetrating keratoplasty substantially. With modern large diameter designs and capacity to modify sagittal height independent of base curve, there is no cone too steep to be fit.”
In terms of cases to avoid, Dr. Jacobs said there are no specific contraindications. “Patients with neurotrophic keratitis are at risk of complications with any contact lens, but scleral lenses can promote healing and clearing of the cornea in children with familial dysautonomia and patients with neurotrophic keratitis from tumor, surgery, herpes simplex, or herpes zoster,” she said. “Interestingly, patients with non-specific dry eye, dry eye after LASIK, or Sjogren’s syndrome tend to fail with scleral lenses. They can be hypersensitive to the presence of the lens on the eye, and if they have excellent vision at the 20/20 or 20/25 level, they may find that the lenses, which add optical interfaces, degrade the vision to an intolerable level.”
Dr. Mian added that scleral lenses may be particularly helpful for those dry eye patients who are seeking to wear contact lenses. A lot of patients with dry eye disease have a hard time tolerating ordinary soft contact lenses but still would like to wear them so they don’t need glasses to see. Scleral lenses are an alternative that helps both their vision and dry eye disease.
He also discussed how scleral lenses may be beneficial for patients with other conditions. For example, they could be helpful in patients who have neurotrophic corneal disease. They have decreased sensation, so the surface breaks down more easily, Dr. Mian said, and these patients can benefit from scleral lenses because they add to the tear film and add a layer of protection. Similarly, he said that patients who have exposure keratopathy, where the eyes don’t close well, tend to have problems with surface and dry eye disease abrasions, so these lenses could be helpful.
Managing patients
In terms of comanaging patients with an optometrist, Dr. Jacobs said that some optometrists may think that once the patient is fit and trained in insertion and removal, they don’t need to be seen for a whole year, such as would be the case for an ordinary soft contact lens patient. “This is not the case for patients with dry eye or ocular surface disease,” she said. “Patients should be seen ideally a month or so after fitting to ascertain that they are doing well and that there aren’t any problems with wear and care of the lenses and use of any concomitant medications.” Dr. Jacobs noted that she has seen a number of patients who misunderstood instructions and were using multipurpose solution to fill their lenses, creating a toxic epitheliopathy that took many months to recover from. After the 1-month check, the patient should be seen after about 3–4 months, then after 6 months, she said, noting that she typically arranges to see the patient the same day as the optometrist if the patient lives far away. If all is well, she will see the patient yearly after that. In many cases, Dr. Jacobs likes to set up a schedule so the optometrist is seeing the patient annually and she is as well, with visits spaced 6 months apart.
Dr. Mian said it requires good communication, as with any comanagement situation. He said it’s important to ensure that the doctors you’re partnering with recognize the extent of the medical problems the patient has. Whether it’s dry eye, autoimmune disease, ectasia, LSCD, or neurotrophic issues, these need to be clearly communicated, and there needs to be follow-up communication both ways so the patients’ needs are met. One thing that has changed in the last 5–10 years, Dr. Mian said, is that this has become its own specialty in optometry, so there are residency programs where optometrists learn to do specialty fits. “Someone who has gone through an extensive training program for these lenses would be a good person to partner with because they’re better trained to help patients,” he said.
About the physicians
Deborah S. Jacobs, MD
Associate Professor of Ophthalmology
Harvard Medical School
Boston, Massachusetts
Shahzad Mian, MD
Professor of Ophthalmology and Visual Sciences
University of Michigan
Medical School
Ann Arbor, Michigan
Relevant disclosures
Jacobs: Dompe, TECLens
Mian: None
Contact
Jacobs: Deborah_Jacobs@MEEI.HARVARD.EDU
Mian: smian@med.umich.edu
