Study: We need standardization of dry eye assessment protocols

Contact Lens and Anterior Eye recently published a report attempting to summarize findings for Sjogrens syndrome patients at six different sites. Symptoms (89.4% of patients) and corneal staining (78% of patients) were the most common findings, but their conclusion highlighted "a great deal of inconsistency in dry eye protocols among offices". It's hard to figure out what is best when everyone does it differently! This comment comes in the context of Sjogrens but is true across the board in dry eye.

This problem is exactly what Drs Wang and Craig are talking when they use terms like "methodological heterogeneity" in their beautiful commentary titled "Core Outcome Sets for Clinical Trials in Dry Eye Disease" which accompanied our study "Research Questions and Outcomes Prioritized by Patients With Dry Eye" in JAMA Ophthalmology earlier this month. 

The problem of heterogeneity - from apples and oranges to quince and dragon fruit - is a common observation in dry eye studies as well as throughout TFOS DEWS II's reports and it serves to underscore the crucial importance of the work by epidemiologist Ian Saldanha and colleagues towards the establishment of core outcome sets for clinical trials in dry eye disease.

Cont Lens Anterior Eye. 2018 Aug 18. pii: S1367-0484(18)30044-4. doi: 10.1016/j.clae.2018.08.006. [Epub ahead of print]
Sjogren's syndrome in optometric practices in North America.
Caffery B, Harthan J, Srinivasan S, Acs M, Barnett M, Edmonds C, Johnson-Tong L, Maharaj R, Pemberton B, Papinski D.

Abstract
PURPOSE:
To describe the presentation of dry eye in Sjogren's syndrome (SS) in optometric practices, to report on the methodology used in dry eye monitoring and to explore the level of corneal staining versus age and time of disease.

METHODS:
Records of SS patients were reviewed in 6 optometric sites. A standardized abstraction tool was developed to collect data from the records including: health history, medications and symptoms and signs of dry eye. The methods of testing symptoms and signs of dry eye were recorded. Variables were recorded at each site and collated at the University of Waterloo. The first visit after January 1, 2000 was selected for description in this paper.

RESULTS:
123 charts were included. The average time since diagnosis was 7.2 years ±5.1 years. Symptoms of dryness were present in 110/123 = 89.4% of charts. Corneal fluorescein staining was present in 96/123 = 78% of charts. MGD was present in 52% of charts. There were significant differences in the protocols and grading systems used in these 6 sites. Corneal staining levels did not change with greater age or length of disease.

CONCLUSION:
These 123 SS patients presented with a large variation in their symptoms and signs. Symptoms of dryness and corneal fluorescein staining were the most commonly recorded presentations. There was a great deal of inconsistency in dry eye protocols among offices. Future prospective research with standardized testing will contribute to our understanding of the best dry eye protocols for SS patients.

Who gets dry eye and why?

Sidebar: Happily back in the saddle, yet heading in new directions

I have really, really missed writing about dry eye these last couple of way-too-busy years. So it's been terribly fun finding a new stride with a self-imposed daily writing schedule for Dry Eye Awareness Month.

The rhythm I seem to be getting into is that, for every conventional sounding dry eye topic I start to tackle, I cast an eye over the vast array of readily available information online (good, bad, and indifferent), then rather than attempting to distill it into something useful, I gently set it all aside, and then go full tilt at some totally neglected aspect that particularly interests or concerns me personally, on behalf of patients struggling to navigate the dry eye world. So that is what you can expect on today's topic and probably everything else coming down the pipeline through the end of this exciting month.

— Rebecca

A nod to epidemiology and all that... jazz

When you talk about who gets a disease and why, it's all about statistics and the field of epidemiology, which among other things seeks to establish "incidence" and "prevalence" and "risk factors" (how many people is it happening to, and what things they have in common), and grapples with all the inherent problems of trying to establish those things for a particular type or category of disease.

I was thrilled to have the privilege of spending time with the TFOS DEWS II

Epidemiology Subcommittee

in Paris the year before last (as part of my responsibility to the

Public Awareness and Education Subcommittee

of the same project) just as they were getting underway with ambitious plans to update and revise the epidemiology section of the original

DEWS

report (2007). The team is absolutely amazing — I will not forget a single one of them. And I learned a lot about the process and challenges of trying to do meta-analysis on 10 years worth of diverse studies, and even got to have some input about topics we as patients could benefit from. Right now I'm literally counting down the days till the brand-new report is published! The epidemiology section is one of the ones I'm most anxious for everyone to have access to - two other favorites being

Iatrogenic Dry Eye

and

Pain and Sensation

.

Meantime though, I'm going to include the risk factors table from the 2007 report. Nothing terribly exciting, though I do think there are points of interest, for example, the fact that while there is "mostly consistent" evidence that older and and female sex are risk factors, evidence for menopause itself being a risk factor is unclear.

... Moving on to areas of closer personal interest:

Not that I mean to brush aside epidemiology — not by a long shot. Once the report is in the public domain, I know I'll be writing up a storm about some of the new trends being revealed in the medical literature.

But... there's a more human side to this issue that I care about, and the epidemiology data that I'll be looking for is predominantly as it relates to this:

the vast range of circumstances and ways in which dry eye occurs and plays out in real people's lives.

There are two aspects of this that I find particularly interesting.

First, the reality of WHO gets dry eye.

Statistics are just no good at conveying it.

Averages don't matter to an outlier or a resident of a slimmer column.

The reality of dry eye is so very, very far from the stereotypical menopausal women's club. 

MEN

get dry eye and for all kinds of reasons, from twentysomethings who took a short course of Accutaine to thirtysomethings who had LASIK to fortysomethings with Sjogrens Syndrome (yes, men do get Sjogrens) to fiftysomethings with nocturnal lagophthalmos and CPAP to sixtysomethings after cataract surgery and right on down the decades. 

YOUNG ADULTS

get dry eyes, with truly poignant impact at sensitive times of life. How would you like to be a college student or young person making your way in a career when your eyes are suspiciously red all the time or your computer time is severely limited?

CHILDREN

get dry eye. Imagine being a parent of a three-year-old whose eyes dry out to such an extent that their vision is endangered. What's the best way to protect them overnight: do you tape their lids shut, or try to jury-rig a moisture goggle designed for adults, or re-apply salve every hour through the night?

WOMEN IN PERFECT HEALTH

get dry eye. No auto-immune disease. No medications. Ideal diet and fitness. These women put me to shame with how well they have looked after their bodies over the years, and yet, this happened. Why?

PEOPLE WHO TOOK EVERY PRECAUTION

get dry eye. The ones who underwent an elective surgery (vision correction, or cosmetic eyelid surgery, for example) only after extensive research, careful selection of a highly qualified surgeon, and thorough screening. Chances are that the phrase "dry eye" mentioned in the consent form did not convey the practical reality of how dry eye can play out.

Second, the dry eye 'acceleration' process. 

I'm not quite sure what else to call it, but it's a phenomenon that fascinates me. I mentioned briefly the other day something about the fact that there's a vast difference between mild bit-of-a-nuisance dry eye and DRY EYE, all caps. One of my big areas of interest is exactly how people move from the former to the latter category. 

Incidentally... most people in the ALL CAPS dry eye category are intimately acquainted with the distinction between these two things because most have had well-meaning friends and family say things like "Oh, yes, I have dry eyes too. You should try some eye drops. Works great." To which one can only smile and try not to roll one's eyes too visibly, as the other party just doesn't get it. There's dry eye, and there's DRY EYE. Different animals.

Now to clarify, when I talk about an acceleration of dry eye, I don't necessarily even mean the eyes getting drier. I only mean a fairly dramatic change in the symptoms one is experiencing — which

may, or may not

, be occurring in parallel with a change in the nature and/or severity of one's clinical presentation of dry eye.  

I'm a 'pattern-seeking' kind of thinker, always lining up data, including stories, in my mind to glean the factors in common. And the pattern I have come across constantly in dry eye is that of people who had more than one pre-existing conditions and/or risk factors but no seriously bothersome symptoms until along comes a reasonably clear 'trigger', something that appears to have pushed them over the edge into full-blown, life-altering dry eye symptoms, which, when they are not easily reversed, can so easily end up precipitating an actual life crisis. By life crisis, I mean that period, thankfully not permanent, when dealing with dry eye takes over your life for a while and, in doing so, probably knocks you clean into a significantly anxious, depressive state for awhile. I'll be talking more in a few days about how the latter part plays out.

Anyway, I've heard these stories echoing that triggering process day in, day out for many years. Sometimes the people experiencing it recognize this themselves, sometimes not. Sometimes the trigger is obvious, sometimes not. I just know that in the course of conversation, with those who get a 'sudden onset' of dry eye symptoms, there are almost always at least two or three noticeable things  about their history that make it clear they were at higher risk: a long history of contact lens wear, or a propensity to get styes, or hormonal fluctuations, or taking some eye medication chronically with a toxic preservative, or they have been told they sleep with their lids partially open, or they had LASIK ten years ago, or they have facial rosacea, and on, and on, and on.

The common thread is the absence of bothersome symptoms, so they didn't necessarily have any clue about what might be brewing. That's not to say that it's always preventable anyway. But it would be good to have more data on these less obvious risk factors in order to educate people on simple ways to exercise prevention. 

Which takes us right back to... epidemiology studies. Can't wait for that report!