This article is more than 5 years old. Information may no longer be current.
PROOF that symptoms matter
Enrollment data from the PROOF study can be applied in a dry eye practice.
Click Here to Manage Email Alerts
For more than 15 years, eye doctors who specialized in the treatment of dry eye have been like the “red-headed stepchild” of the eye care world, mumbling in the corner about the extent of the effects of dry eye on the ocular surface. The notion that dry eye of all sorts was a major contributor to vision problems was particularly heretical. The dry eye corner was a very lonely place for a very long time.
What was once described as the “crabgrass of ophthalmology” is now the “hot dot” in eye care. I think what may have turned the tide was Bill Trattler’s study showing the effect of dry eye on corneal topography and post-cataract surgery visual acuity; a clear and significant improvement in postop vision was shown when preop dry eye was treated. Still, there was a lingering skepticism about dry eye and its effect on visual performance.
Now? Well, now we have PROOF. Funded by Allergan and led by Peter McDonnell at the Wilmer Eye Institute, the Progression of Ocular Findings study was launched at the Association for Research in Vision and Ophthalmology meeting in 2013 to evaluate the natural history of untreated dry eye. This is a certifiable big deal for everyone who has a hand in the dry eye world. Think about this for a minute: Peter McDonnell! The Wilmer Eye Institute! I feel a bit like the hyenas in The Lion King. Mufasa. Mufasa! MCDONNELL! Kinda gives you the shivers.
About PROOF
Demonstrating that dry eye is progressive will provide eye doctors with a rationale to begin treatment as soon as a diagnosis is made. This in turn will encourage industry to explore an increasing universe of new treatments. PROOF will use the DEWS dry eye diagnostic criteria, and 217 patients with DEWS level 2 dry eye make up the study group. Increases in signs or symptoms that show an increase in DEWS level will constitute a significant endpoint. The study is expected to last 5 years with examinations every 6 months.
What is particularly interesting in PROOF is that the entry characteristics of the study participants and the controls are starkly different when it comes to vision. The median visual acuity was 20/20 in both groups. However, the overwhelming majority of study subjects with dry eye complained of moderate or severe blurred vision. I recently attended a meeting where the speaker noted that 57.6% of dry eye patients in the study complained of moderate, severe or very severe blurred vision compared with only 10.5% of controls. This is rather clear confirmation of the visual effects of dry eye, even in patients who have what would be described as moderate dry eye.
Symptoms are how dry eye patients identify themselves in our offices and clinics. What the PROOF study entry characteristics tell us is that we should be on the alert for all kinds of vision symptoms as a “red flag” for dry eye. Indeed, it has been our experience at SkyVision that the earlier we learn that a patient may be suffering in some way with dry eye, the more effective our care becomes. Let me share with you a bit of “how to” when it comes to measuring dry eye symptoms.
Measuring symptoms
What starts every exam are two general questions: “How are you seeing?” and “How are your eyes feeling?” You could stop right there, simply recording the patient narrative and then referring back to symptoms previously uncovered at preceding exams in order to assess the effectiveness of your interventions. Because we seek to track not only individual symptoms but also a more quantifiable “dry eye symptom load,” we have found it helpful to add a questionnaire to our process that generates a numerical symptom score. There are two good ones out there, the Ocular Surface Disease Index (OSDI) and the Standard Patient Evaluation of Eye Dryness (SPEED).
You can think of the OSDI and SPEED tests as the symptom equivalents to tear osmolarity (TearLab) and InflammaDry MMP-9 testing (RPS): Both of them give useful and complementary information, and every dry eye practice should routinely use one (or both). Each test assesses the incidence and perceived severity of symptoms that are commonly associated with dry eye. Both generate a numerical score that is roughly correlated with the impact of dry eye on a patient. This score can then be used to make the treat/do not treat decision, and you can easily follow trends by graphing the OSDI and SPEED scores.
There are different philosophies as far as when these tests should be administered. For more than 10 years, we have asked patients to fill out an OSDI after a technician has completed her interview and while the patient is waiting to see the doctor. This works well in the flow of a busy anterior segment practice. This is a common pattern in a practice such as ours that has found Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) and other anti-inflammatory treatment to be successful in treating dry eye.
In much the same way as Allergan first encouraged the use of the OSDI, TearScience was among the first to embrace the SPEED test. The typical application in this process would be to give most patients in the office a SPEED as part of their intake experience, sometimes even in the waiting room before any formal history taking. A SPEED score greater than 6 would then initiate the dry eye exam. This is probably an effective way to ease your staff into a dry eye mindset; dry eye patients will identify themselves without needing a staff member to pick up on a cue in the history. For what it is worth, we are using both tests at the same place and in the same way we have traditionally used the OSDI. Again, like tear osmolarity and InflammaDry, we get complementary and actionable data from both.
If you look closely at the OSDI and SPEED, you notice right away that visual symptoms are prominent features of both. Four out of 15 questions on the SPEED and six out of 12 questions on the OSDI directly address visual symptoms. These validated questionnaires both emphasize the visual effects of dry eye. Just like Dr. McDonnell and the PROOF team noted in their first observations about the differences between dry eye patients and normal patients. Just like all of the red-headed stepchildren mumbling over in the corner, lo these many years. But that is all right. We are OK. Now that we have PROOF, we will just channel another Lion King stalwart, the great philosopher Rafiki after he bopped Simba on the head:
“It doesn’t matter; it’s in the past!”
For more information:
Darrell E. White, MD, can be reached at SkyVision Centers, 2237 Crocker Road, Suite 100, Westlake, OH 44145; email: dwhite@healio.com.Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Nicox, Shire and Eyemaginations and on the speakers board for Bausch + Lomb and Allergan.