Interesting Excerpts from a PCON article by Dr. Eldridge.
Full article: http://www.pconsupersite.com/view.aspx?rid=77125
Making the diagnosis
if a patient’s osmolarity is consistently low in both eyes, their symptoms are most likely not caused by dry eye disease, but by an undetected allergy, infection or inflammation around the nerve. With consistently low osmolarity, you can be confident that the lacrimal and meibomian glands are doing their job. “TearLab is extremely accurate, but it shouldn’t replace the clinician’s skills in differential diagnosis,” Dr. Eldridge added. “It may be necessary to take a few readings over time to get a clear picture. This is not unlike our glaucoma patients when we repeat tonometry or visual fields to confirm our clinical suspicions.”
Dr. Foulks agreed, saying his study results indicate the need to evaluate values from one eye vs. the other. “In those patients suspected of having mild dry eye, it may take more than one measurement to prove your point,” he said.
Future directions
If tear osmolarity can function as a surrogate biomarker of disease severity, and if it can give clinicians an accurate portrayal of response to therapy over time, the testing modality may also be important for clinical trials involving new therapies for dry eye. Currently, the U.S. Food and Drug Administration does not recognize surrogate biomarkers as an endpoint upon which to base approval of new drugs or therapies. In October, TearLab Corp. announced that according to the recommended payment determination for new codes issued by the Committee for Medicare and Medicaid Services, a new Current Procedural Terminology (CPT) code will apply to the TearLab Osmolarity Test as of January 2011 for reimbursement of $24.01 per eye. According to a company press release, “reimbursement by CMS will only be available for offices with a moderate complex Clinical Laboratory Improvement Amendments (CLIA) certificate until TearLab receives a CLIA waiver categorization from the FDA. – by Nancy Hemphill, ELS, and Bryan Bechtel
Original Article written by:
Chuck Aldridge, OD,
David C. Eldridge, OD, FAAO,
Gary N. Foulks, MD, FACS,
William Townsend, OD,
