According to the 2017 TFOS DEWS II Report, dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles.1
The lack of correlation between clinical signs and symptoms of dry eye disease makes diagnosing and treating patients a challenge. Additionally, inflammation is often present before the clinical signs of dry eye.2
InflammaDry® is the first rapid, in-office, CLIA-waived test that detects elevated levels of MMP-9, an inflammatory marker that is consistently elevated in the tears of patients with dry eye disease. Other dry eye tests only measure tear production and stability.
Using direct sampling microfiltration technology, InflammaDry® accurately identifies elevated levels of MMP-9 protein in tear fluid samples taken from the inside lining of the lower eyelid, the palpebral conjunctiva.
This disposable, low-cost test requires no additional equipment for administration or the interpretation of results—which are highly accurate with 85% sensitivity and 94% specificity.3
Using four simple steps, InflammaDry® results are achieved in just 10 minutes, aiding in the diagnosis of dry eye before the patient leaves the office.
Clinical benefits:
- Pre-surgical measurements are more accurate and post-surgical outcomes are improved by identifying and treating patients with dry eye.4
- Post-surgical complications, such as corneal wound healing, can be reduced by identifying dry eye prior to surgery.1
- Therapeutic treatment of dry eye improves patient quality of life.5
InflammaDry® in Practice
Dr. Devries said he became involved with DED out of necessity as a result of his role in the medical-surgical co-management group he started thirty years ago. He said an important dynamic they uncovered is that in surgical practices, there is a much higher percentage of patients with significant DED than typically national averages.
“So it really became important in our practice because it was such a high percentage,” Devries said. “That's how I became so involved in looking at [dry eye] and why it dovetails so nicely into point-of-care testing.”
When he heard about InflammaDry®—that a test with this sensitivity and specificity was being released—"I jumped on it right away,” he said.
“I want to know which of my patients have a high MMP-9 for a variety of reasons,” Devries explained. “We need to know if this inflammation is present because it really helps differentiate some of the diagnoses, as well.”
Rapid Results Boost Patient Engagement
Being able to do the testing in the office with rapid results he can discuss with the patient is one of the things Devries likes best.
“I can say, based on this test, you have this inflammatory response,” he said, adding that additional POC testing can then aid in a more specific diagnosis. “It really is something you can give the patient to grab onto that shows you’re not just winging it.”
The same is true when it comes to monitoring the effectiveness of treatments.
“Then the patient can get involved,” he explained. “If there's point-of-care testing, the first thing they'll say is, “Doctor, how's my inflammation? How is the treatment coming along?’”
Devries added that if the patient is doing well and then has a flare for some reason—such as allergy season—POC testing with InflammaDry® will reflect that.
“Then you start talking to the patient in terms of a little different direction and helping differentiate treatment as well,” he said.
As far as deciding which patients should be tested, Devries said they use a SPEED™ questionnaire, which helps determine selection.
“Anybody who is a six or above automatically gets the point-of-care testing, unless their insurance precludes it and then we'll approach them with an ABN to do it,” he explained. “It’s amazing. A lot of patients who are used to doing it, if they switch insurance, they're willing to go ahead and pay for that information once they understand it.”
Devries said the POC testing also helps motivate patients to start recommended treatments—especially when it can be triangulated with other POC testing results, such as meibography and osmolarity.
“When you're able to triangulate that, they feel better about what you're telling them,” he explained. “I think they realize then that yes, something has to be done.”
Additionally, patients appreciate knowing that their progress will be monitored.
“When you explain to them that you're going to be monitoring their progress with ‘follow-up labs’ to see what happens with that inflammation, they like that idea,” Devries said.
Optimizing the Ocular Surface Prior to Surgery
In terms of the need to optimize the ocular surface prior to a surgical procedure, Devries underscored the growing awareness of how important this is for better outcomes.
“And patients get that,” he said. “Patients understand that you're trying to get the best possible results.”
He also recommended that colleagues who are referring patients for surgery include an inflammatory workup as part of the process.
“I think point-of-care testing is a huge part of that,” Devries said. “Ask the questions, whether it's a questionnaire or just asking the questions in the case history. And then do the point-of-care testing when [appropriate]. There is not a referral center in this country that wouldn't love every patient to be prescreened and have an inflammatory done and treatment initiated prior to the referral.”
When that’s not the case and patients are referred and eager to have surgery, they may be disappointed to learn they have inflammation that must be treated first.
In that light, Devries emphasized that it’s important for the referring doctor to be aware of inflammatory issues to help patients know what to expect related to the timing of surgery.
“Then everybody's on the same page,” he said.
Reimbursement and Revenue
As far as reimbursement, Devries said most insurance plans cover InflammaDry® POC testing, but if there’s a concern about coverage, his practice offers patients the ABN form.
And for providers who are wondering whether this is a revenue generator, Devries offered the reminder that the potential profit isn’t in the testing—but in the treatment that’s needed based on the results.
“The point-of-care test itself, while it will create a positive cash flow, isn't where the revenue is in the practice,” he explained. “It’s in the subsequent visits, treatments, and procedures you're going to do. That's where the revenue lies. Honestly, I would do the point-of-care tests like inflammatory at a slight loss just to get the information, to get those patients into the stream of being treated.”
References
- Nelson J.D. et al. TFOS Dew II Introduction. The Ocular Surface. 2017 July; 15(3):269-275.
- Sambursky R., O’Brien T.P. MMP-9 and the perioperative management of LASIK surgery. Curr Opin Ophthalmol. 2011 Jul 22; 22(4): 294-303.
- RPS InflammaDry® sensitivity and specificity was compared to clinical truth in RPS clinical study: protocol #100310.
- Shtein R.M. Post-LASIK dry eye. Expert Rev Ophthalmol. 2011 Oct; 6(5): 575-582.
- Schiffman R.M., Walt J.G., Jacobsen G. et al. Utility assessment among patients with dry eye disease. Opthalmol. 2003 Jul; 110(7): 1412-9.
