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June 2009
 

OPHTHALMOLOGY NEWS
 

Taking a second look at scleral lenses






by Vanessa Caceres EyeWorld Contributing Editor
 

 



 

Severe dry-eye patients could benefit from this often-overlooked option

Schematic diagram of the Boston Ocular Surface Prosthesis


Slitlamp photo of the Boston Ocular Surface Prosthesis in place on a patient's eye Source: Deobrah S. Jacobs, M.D.



Scleral lenses for dry-eye treatment have been plagued with misconceptions—they’re uncomfortable, bulky, and hard to care for, say some doctors.
But recently, scleral lenses have gained attention for their success in severe dry-eye patients who otherwise may have no options. In fact, at the Boston Foundation for Sight, Needham, Mass., the Boston Ocular Surface Prosthesis (formerly the Boston Scleral Lens Prosthetic Device) is fitted in 300 patients a year, compared with 50 patients a year just five years ago, said Deborah S. Jacobs, M.D., medical director, Boston Foundation for Sight.
“More than half of those who are fitted are fitted for ocular surface disease,” she said. The foundation attributes this increase to a growing awareness of ocular surface disorders (including dry eye) and a growth in ocular surface problems.
“The Boston scleral lens offers a nice option for ocular surface patients who have reached a dead end with topical treatment,” said Robert Latkany, M.D., founder and director, Dry Eye Clinic, New York Eye and Ear Infirmary, New York. “In a sense, it offers covering over the compromised surface and therefore will reduce symptoms.”
Still, not all ophthalmologists or even optometrists are aware of the possible success of scleral lenses in dry-eye patients, said Rebecca Petris, founder, Dry Eye Company, Silverdale, Wash. Ms. Petris uses the Boston prosthesis in both of her eyes, and as operator of the Web site Dry Eye Zone, www.dryeyezone.com, she receives weekly queries from patients who want to know how effective scleral lenses are.
“So few doctors understand what they’re really like. These are patients who are at the end of their rope and are about to file for disability or have their eyelids sewn shut. When I ask them if they’ve heard of sclerals, they say no, or that their doctor said they won’t help dry eye and that they’ll hurt,” Ms. Petris said. “Clearly, the information out there is not sufficient.”
Although several kinds of scleral lenses are available in the United States, the Boston prosthesis is arguably the most well-known. According to the foundation’s Web site, their lens is “an oxygen permeable optical shell that fits under the lids and over the front surface of the eye.” It fits on the sclera and immerses the eye in a pool of artificial tears. “The fluid reservoir of the device masks the distorted surface of the cornea to improve vision and provides a protective cushion that reduces pain and photosensitivity caused by inflamed and irritated corneas and dry eyes,” according to the Web site.
Scleral lenses can be used in patients who are otherwise contact-lens intolerant, Dr. Jacobs said. “The majority of our patients were declared contact-lens intolerant,” she said.


Who’s using scleral lenses


The Boston lens was approved in the early 1990s to treat corneal and ocular surface diseases and ectasia, Dr. Jacobs said. The goal of the lens was to help patients for whom gas-permeable lenses could not be used.
Scleral lenses are commonly known for their use in patients with Stevens-Johnson syndrome, keratoconus, corneal grafts, chemical and thermal burn injuries, and ocular pemphigoid, among other uses. However, the recent spotlight on scleral lenses has led to their use in an increased number of patients with severe dry eyes due to Sjögren’s syndrome, autoimmune diseases, chronic graft-versus-host disease, post-LASIK dry eye, and irregular astigmatism, Dr. Jacobs said.
Scleral lenses are a solid option for patients who have trouble with toric soft lenses or other types of contact lenses, said Greg Gemoules, O.D., Coppell, Texas. Dr. Gemoules frequently fits sclerals and assists in the development of mini-scleral lenses made by TruForm Optics (Euless, Texas). For example, one of his patients is a high school baseball player with severe dry eye and allergies who could not tolerate silicone hydrogels because he continued to experience papillary conjunctivitis. Another scleral user is a 72-year-old man with high astigmatism who could never tolerate contact lenses and who developed corneal dystrophy following successful cataract surgery.
“A year ago, 95% of my scleral or semi-scleral fits were keratoconus or post-LASIK. These now account for just 50% of new scleral fits today,” he said. “Newer designs are less bulky and patients find them less intimidating.” Still, scleral lenses are not a first-line therapy for dry eye because of the effort it takes to fit them and because of their high price tag, which is not always covered by insurance. “In some patients, we have gone the route of exhausting all other treatment options such as Restasis [cyclosporine ophthalmic emulsion, Allergan, Irvine, Calif.] and punctal occlusion. In others, it’s a case of providing a more appropriate contact lens solution,” Dr. Gemoules said.
“These are patients whose quality of life has been affected,” Dr. Jacobs said. In addition to Restasis and punctal occlusion, lubricants, serum tears, and doxycycline [various manufacturers] may have provided little or no relief to patients who are considering scleral lenses, she said.
Ms. Petris, who was fitted for scleral lenses both for vision problems and severe dry eye, believes they should be considered before tarsorrhaphy.
“If patients can get over the hurdle of having a lens in their eye and feel all other treatment options have failed, the Boston scleral lens is a great next step,” Dr. Latkany said.


The logistics


In most cases, patients who are fitted for the Boston prosthesis must go in person to the Needham office for a fitting. (Editors’ note: There are now other locations for fittings, discussed later in this article.) Patients usually stay in the Needham area for five days to two weeks until the custom fit made for each patient is completed, according to the foundation’s Web site.
Ms. Petris said she was properly fitted after three trial sets of lenses. “They manufacture and test until they optimize the fit,” she said. Because of the long stay patients must experience, the foundation includes a kids’ room, a kitchen, phones, computers, and even a darkened room for patients with light sensitivity.
Once patients and staff find the right fit, the staff gives a lengthy training on how to care for the prosthesis and how to place it in the eye, Ms. Petris said. The care process is probably easier for patients who have worn contact lenses before, she said. Dr. Gemoules is streamlining the fitting process with the use of ocular coherence tomography (OCT), a process that he published on in the March 2008 issue of Eye and Contact Lens. “High resolution biometry proved to be a highly useful fitting tool and seems to offer a more accurate and efficient alternative to fitting scleral-type lenses compared with the trial lens method,” he wrote in the study. With the use of OCT, he can often fit the mini-scleral lenses he uses in one to two fittings. (The mini-sclerals are about 16 to 18 mm on average, compared with 16 to 23 mm for a Boston prosthesis.) Scleral lens manufacturers are working with insurers so that the lenses will be covered more often. For example, staff members at the Boston Foundation for Sight file appeals for patients if their insurer will not cover the cost for them. (The cost is $7,600 for both eyes and $5,000 for one eye.) A number of insurers in Massachusetts are more familiar with the lens now and will cover it, Dr. Jacobs said. As the Boston Foundation for Sight is a 501(c)3 nonprofit, they can help cover medical costs and lodging for patients who cannot otherwise afford the prosthesis.
“Thirty to forty percent of our care is provided as free care for patients who don’t have the means,” Dr. Jacobs said.
Dr. Gemoules said scleral lenses can take a “massive” amount of chair time, hence leading to their higher costs. However, he’s found that up to 60% of insurers will cover for their cost, particularly in patients with conditions such as keratoconus.


Visual results, looking ahead


A few reports have measured visual results and patient satisfaction with scleral lenses. A study published in the December 2007 issue of Cornea involving 33 chronic graft-versus-host disease patients with severe dry eye found that the Boston prosthesis resulted in the highest possible improvement in pain (52% of patients), photophobia (63%), and quality of life (73%). That study was written by Dr. Jacobs and Perry Rosenthal, M.D., president and founder, Boston Foundation for Sight.
“I’m a very happy and grateful user,” said Ms. Petris. She is able to wear the lenses all day and does not feel any sensation from them. She removes the lenses to sleep, nap, or when on an airplane. The hardest part was getting used to their insertion and extra care when she initially was fitted for the lenses in 2006.
The use of the Boston prosthesis should grow in 2009 with beta sites for fitting at the Doheny Eye Institute, University of Southern California, Los Angeles; Cullen Eye Institute, Baylor Medical College, Houston; and Brooke Army Medical Center in San Antonio, Dr. Jacobs said. There are also doctors who have received training and who are doing fittings in Mumbai, India, and Nagoya, Japan, she said.
With the recent attention on scleral lenses for dry eye, they may become less of a mystery and more of a viable option for a growing number of patients, Dr. Gemoules said.



Editors’ note: Dr. Jacobs is medical director of the Boston Foundation for Sight (Needham, Mass.), but she does not have financial interests in the Boston Ocular Surface Prosthesis. Dr. Latkany has no financial interests related to his comments. Ms. Petris has no financial interests related to her comments. Dr. Gemoules is involved in the development of the TruForm Optics (Euless, Texas) scleral lenses.



Contact information

Gemoules: 972-462-7311, dr_leuk@leukoma.com
Jacobs: 781-726-7337, djacobs@bostonsight.org
Latkany: 212-689-2020, relief@dryeyedoctor.com
Petris: 877-693-7939 x717, rebecca@dryeyecompany.com







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