As the definition of dry eye disease evolves, so, too, does the diagnostic and treatment technology.
When the Tear Film and Ocular Surface Society, or TFOS, held meetings of its Dry Eye Workshop II (DEWS II), its members established one of the goals was updating the definition of “dry eye disease.” Consider: In 1995, the NEI defined dry eye as “tear deficiency or excessive tear evaporation, which causes damage to the interpalpebral ocular surface and is associated with symptoms of discomfort.”1 In 2007, the TFOS, following its first Dry Eye Workshop, began describing dry eye as a “multifactorial disease of the tears and the ocular surface.”2
By 2017, DEWS II had updated the definition further. Dry eye, it said, “is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.”3
While many traditional tools are still important—such as the Dry Eye Questionnaire or Ocular Surface Disease Index, staining, and tear break-up time—diagnostic technology has evolved along with the definition, with several devices introduced in the last year alone. New treatment devices have evolved as well.
Earlier this year, Quantel Medical debuted its LacryDiag ocular surface analyzer, which has been approved by the U.S. Food and Drug Administration. LacryDiag allows you to perform a noncontact exam, measuring the lipid, aqueous and mucinic layers of the tear film.
Specifically, you can perform interferometry and meibography, plus you can measure tear meniscus height and non-invasive tear break-up time—all of which are recommended in DEWS-II. You can then obtain an exam report, complete with patient images, and edit in one click.
CRYSTAL TEAR REPORT
OCULUS added a Crystal TEAR Report to its Keratograph 5M corneal topographer. The report walks you through all the necessary assessment criteria for a comprehensive dry eye analysis, lets you manually enter your dosage recommendations for individual treatments and summarizes all results in a printout that can also be used for patient education. The printout includes your personal logo on the Crystal TEAR Report, an easy-to-understand color-coded pie chart for assessment of dry eye disease, explanations of abbreviations and technical terms that the patient can understand, comprehensible presentation of individual measurements and their results, clear explanation of the treatment goal along with the necessary therapeutic steps and space for the doctor’s personal recommendation.
OCuSOFT Inc. formed a distribution agreement with I-MED Pharma Inc., a Montreal-based biotechnology company to make the I-PEN Osmolarity System available in the United States. The handheld device uses sensors that allow you to measure the palpebral conjunctiva to determine osmolarity. The I-PEN measures the electrical impedance in the tear-soaked tissues 192 times in less than five seconds and calculates the osmolarity of the tear film of the eye.
Also on the osmolarity front, TearLab Corporation launched the TearLab Osmolarity System in Brazil in March and later this year plans to resubmit its 510(k) filing with the FDA after addressing the agency’s questions. With TearLab, you can measure the osmolarity of tears in patients you believe may have dry eye disease. The system consists of the TearLab Osmolarity Test Card, the Osmolarity Test Pen, which holds the test card while you collect the tear samples, and the TearLab Osmolarity System, which then measures osmolarity.
A reading of more than 300 mOsm/L, indicates loss of homeostasis, and a difference of more than 8 mOsm/L indicates instability of the tear film, according to the company, which added that the test has a positive predictive value of 89%.
Sight Sciences, Inc., initiated the OLYMPIA study of its TearCare System in patients with dry eye disease. The TearCare System is fully customizable and allows the patient’s eyes to remain open and blinking during the procedure. Soft, flexible devices conform to the eyelids to deliver a sufficient level of energy for a specific period of time to liquefy meibum. The randomized, controlled trial is evaluating the safety and effectiveness of the TearCare System vs. a daily regimen of combined warm compress therapy and lid massage. The primary endpoint is tear breakup time at one month, and several other endpoints will be evaluated to assess changes in patients’ dry eye signs and symptoms.
Researchers will follow individuals for six months, re-treat them, and then follow them for another six months. The device is expected to be available in 2019.
The iLux evaporative dry eye system from Tear Film Innovations received 510(k) clearance from the FDA in December 2017. The system lets you view the eyelid margin through the magnifier, then warm the eyelid tissue within a therapeutic target range to melt the meibum blocking the orifices, and then apply compression to the eyelid to express the melted meibum through the orifices. iLux can treat both upper and lower eyelids. You control the amount of heat and pressure at all times.
The sterile, single-patient-use, disposable iLux Smart Tip has an inner pad and an outer pad. The inner pad slips behind the eyelid being treated, while the outer pad is pressed against the outer surface of the eyelid during heating and compression. Both pads are covered with a soft, biocompatible silicone material.
The iLux Smart Tip contains precision temperature sensors that continually monitor inner and outer eyelid temperature and maintain safe, therapeutic heat levels during treatment.
1. Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32.
2. The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92.
3. Nelson JD, Craig JP, Akpek EK, et al. TFOS DEWS II Introduction. Ocul Surf. 2017 Jul;15(3):269-275.
WHERE TO FIND IT
888.284.8004 | OculusUSA.com
800.233.5469 | OCuSOFT.com
Quantel Medical USA
877.782.6835 | Quantel-Medical.com
877-266-1144 | SightSciences.com
Tear Film Innovations
844.458.9776 | TearFilm.com
855.832.7522 | TearLab.com