New test changes the way some ODs diagnose and treat dry eye, allergy

Issue: November 2004

ByNancy Hemphill, ELS, FAAO

Some clinicians are finding that the Tear Analyzer, manufactured by Touch Scientific Inc. and distributed by Flex Medical Devices Inc. (FlexMD), is changing the way they diagnose and manage their dry eye and allergy patients.

Erica Morris, OD, of 20/20 Vision Center in Greenville, N.C., said these test results “give you a much more direct path to make patients feel better.”

The Tear Analyzer measures both lactoferrin and IgE levels within the overall tear chemistry, allowing practitioners to differentiate dry eye and allergy patients and helping them choose the most effective treatment regimen more readily.

Dr. Morris has been using the test in her office for several months. “We’re finding that a lot of patients who we really thought had an allergy component actually do not,” Dr. Morris told Primary Care Optometry News. “So we’re able to take them off of some of the medications and treat them for dryness instead. Most often, they are aqueous deficient, and that’s causing a lot of irritation.”

New method of diagnosis

John A. McCall Jr., OD, a private practitioner from Crockett, Texas, said, “With this instrumentation, I feel like we can now add a scientific approach to treating allergies rather than the usual ‘seat-of-the-pants’ approach.

“Prior to using the Tear Analyzer, I diagnosed allergies the same way every other clinician diagnoses allergies,” Dr. McCall explained in an interview. “I asked the patient if his or her eyes itch, and I looked at the objective findings, including follicles, redness and epiphora. After having used the Tear Analyzer for the past 3 months, I now realize a number of patients have allergy problems but do not report itching as one of their subjective symptoms.”

In Dr. Morris’ practice, all patients fill out a medical sheet with baseline questions prior to being seen. “Our technicians are trained to then administer the dry eye questionnaire if they see that patients are reporting certain complaints,” she said. “The questionnaire asks about dryness, irritation, allergies, medications and contact lens use. Then, we review that with the patient in the exam room. If they have three or four of the 10 to 12 symptoms, we’ll use the Tear Analyzer.”

She added that she is using it most often in contact lens wearers and the elderly population.

Dr. McCall said he uses the test on any patient who complains of any type of ocular discomfort, such as dryness, itchiness, burning, scratchiness and epiphora.


	Collecting the tears: The IgE test requires a 2-mL tear sample, while the lactoferrin requires a 0.5-mL sample.	Running the test: Once the tear samples are inserted, the machine will run unattended during the tests.

Administering the test

The staff in the optometrist’s office can be trained to administer the two components of the test, which consists of collecting tears in micro capillary tubes and then introducing the samples into the machine.

Tim Jones, Flex MD vice president of sales, mid-Atlantic, told Primary Care Optometry News that, once trained, technicians can collect tears for both tests in less than 2 minutes.

“Then, the IgE test takes about 12 machine minutes to run, while the lactoferrin takes about 3 minutes,” he said. “A full result for both tests can be returned within 20 minutes.”

Patients can be given the option to either wait for the test results or be contacted later and advised of a treatment plan.

“I try to draw the test early, so the results can be obtained while the patient is having other diagnostic tests or selecting a pair of glasses,” Dr. McCall said. “If the patient is in a hurry, we’ll collect the tear specimen, and, after explaining what the test will tell us, I will send the patient home and call him or her with the results and a treatment plan if needed.”

Choosing a treatment plan

Dr. Morris said the Tear Analyzer test results are a “big part of the decision” when she decides on a treatment plan.

According to Mr. Jones, “The National Eye Institute’s 1995 Industry Workshop on Clinical Trials in Dry Eyes classifies aqueous-deficient dry eye at 0.9 mg/mL of lactoferrin or lower. The normal range is 0.9 to 1.8 mg/mL, with 1.8 mg/mL or higher as evaporative dry eye, according to the manufacturer.”

Dr. McCall said he uses the lactoferrin component test results to help him decide on a treatment strategy for dry eye. “If it’s borderline, I tend to treat with artificial tears,” he said. “If it’s severe aqueous deficiency, I treat with punctum plugs. If it’s mucin deficiency, I prescribe Restasis (cyclosporine, Allergan).”

Mr. Jones continued, “For IgE, the FDA-approved test definitively demonstrates, through clinical trials, that a reading of 80 ng/mL or higher is definitively allergic conjunctivitis. Below 80 ng/mL is considered normal.”

“I had one patient who was 1,595 ng/mL in one eye and 785 ng/mL in the other eye,” Dr. McCall said. “I prescribed my favorite antihistamine/ mast-cell stabilizer, saw the patient back in 2 weeks and retested only the IgE component. Although still high, the IgE in each eye had dropped by more than 75%, so I had him continue the drop. I saw him again in 3 weeks. The eye that was 1,595 ng/mL measured 115 mg/mL, and the eye that was 785 ng/mL measured 0. I told the patient to continue the drops for 2 more weeks and then discontinue them. I instructed him that, according to the lab test, we had stabilized his allergies, so we would discontinue the drops and he should let me know if symptoms recur.”

Dr. Morris said, “A lot of the patients we’re testing have actually had problems before and have either self-medicated or have been using artificial tears, and it’s just not working very well. So once we get the results from the Tear Analyzer, we’re better able to streamline treatment to give them comfort and relief right away, which they really appreciate.”

Both practitioners agreed that, at times, the test results do not coincide with patient complaints or symptoms. “Some patients have given me the textbook symptoms of dry eye, and the lactoferrins and IgE test normal,” Dr. McCall said. “With the absence of presumed viral conjunctivitis, I just usually treat them with tears.”

Reimbursement issues

The average reimbursement from Medicare and major medical is $105 per patient for both tests, according to the manufacturer. The cost to the doctor is about $35 per patient for the kits for both tests.

According to both Dr. Morris and Dr. McCall, optometric offices must first register themselves as a lab with Medicare to obtain reimbursement. Dr. Morris said she was unable to obtain third-party reimbursement immediately, but she is now getting reimbursed from Medicare and Blue Cross/Blue Shield.

Dr. McCall has not yet received Medicare reimbursement, “although my billing department has been told that this is a new technology and the reimbursement will be worked out soon. I am told the net profit, after the kit cost involved for every patient, will be about $78 per patient from Medicare for both tests and an average of $105 for other third-party payers.”

For Your Information:

Erica Morris, OD, practices at 20/20 Vision Center in Greenville, N.C. She can be reached at 3740 South Memorial Dr., #A, Greenville, NC 27834; (252) 754-2020; fax: (252) 493-0100.

John A. McCall Jr., OD, is in private practice in Crockett, Texas, and is senior vice president, vendor relations, for Vision Source. He can be reached at 711 E. Goliad Ave., Crockett, TX 75835; (936) 544-3763; fax: (936) 544-7894; e-mail: sourcejam@aol.com. Neither Dr. Morris nor Dr. McCall has any direct financial interest in the products mentioned in this article, nor are they paid consultants for any companies mentioned.

Tim Jones is vice president sales, mid-Atlantic, for Flex MD. He can be reached at Flex Medical Devices Inc.; e-mail: tjones@flexmd.com.

The Tear Analyzer is available from Flex Medical Devices Inc., 260 E. Davie St., Raleigh, NC 27601; (919) 961-2310; fax: (919) 828-2242; Web site: www.flexmd.com.