signs vs symptoms

It's all about the burning!

Another study just came out on depression and dry eye. But it's not really about depression and dry eye. (Old news.) It's about SYMPTOMS and depression, and of those symptoms, burning specifically.

Clinical signs of eye disease are the driving force behind how optometry and ophthalmology address dry eye. It's the clinical signs that drive what gets written in the chart and on the Rx pad - but it's the symptoms that drive the patients to the doctor, and failure to get relief for those symptoms that drive patients to doctors #2, #3 and #4 and at some stage into depression as well.

Dry eye patients are ruled by symptoms. (Call it pain, actually.) Pure and simple. We do not sink into clinical depression because of our TBUT, osmolarity or meibography scores or our ocular surface staining. We are driven there when we do not get relief from the unremitting burning sensation in our eyes. (It's not a hard concept to understand; sit there with your eyes open for 60 seconds and extrapolate that to "all day" and see how that prospect suits you.)

Eyecare professionals, we need you to listen, and not get so distracted by what you are, or, even more likely, are not seeing under your slit lamp that you fail to see the big picture needs of the patient seeking help. 

Industry and FDA, we need you to listen and not get so hung up on the near impossibility of improving both signs and symptoms that you lose the bigger picture of the NECESSITY of bringing symptom relief to market.

Dear authors of the study linked below: Thank you, thank you, and thank you again for documenting this. We need every bit of increased emphasis on the role of dry eye symptoms that we can get, and especially that key word, "burning".

A thorough understanding of symptoms and patient goals should be driving dry eye research and dry eye treatment and management plans. It should also be playing a more central role in the FDA's dry eye drug approval process.

Am J Ophthalmol. 2018 Apr 12. pii: S0002-9394(18)30164-8. doi: 10.1016/j.ajo.2018.04.004. [Epub ahead of print]
How Are Ocular Signs and Symptoms of Dry Eye Associated with Depression in Women with and without Sjögren's Syndrome?
Gonzales JA1, Chou A2, Rose-Nussbaumer JR1, Bunya VY3, Criswell LA4, Shiboski CH5, Lietman TM1.

Abstract
PURPOSE:
To determine whether ocular phenotypic features of keratoconjunctivitis sicca (KCS) and/or participant-reported symptoms of dry eye disease are associated with depression in women participants enrolled in the Sjögren's International Collaborative Clinical Alliance (SICCA).

DESIGN:
Cross-sectional study.

METHODS:
Women enrolled in the SICCA registry from 9 international research sites. Participants met at least one of five inclusion criteria for registry enrollment (including complaints of dry eyes or dry mouth, a previous diagnosis of Sjögren's syndrome (SS), abnormal serology (positive anti-Sjögren's syndrome-related antigen A and/or B (anti-SSA and/or anti-SSB), or elevated anti-nuclear antibody and rheumatoid factor), bilateral parotid gland enlargement, or multiple dental caries). At baseline, participants had oral, ocular, and rheumatologic examination, blood and saliva collection, and a labial salivary gland biopsy (LSGB). They also completed an interview and questionnaires including assessment of depression with the Patient Health Questionnaire 9 (PHQ-9). Univariate logistic regression was used to assess the association between depression and demographic characteristics, participant-reported health, phenotypic features of Sjögren's syndrome, and participant-reported symptoms. Mixed effects modeling was performed to determine if phenotypic features of KCS and/or participant-reported symptoms of dry eye disease were associated with depression, controlling for health, age, country or residence, and gender and allowing for non-independence within geographic site.

RESULTS:
Dry eye complaints produced a 1.82-fold (95% CI 1.38-2.40) higher odds of having depression compared to being symptom-free (p < 0.001). Additionally, complaints of specific ocular sensations were associated with a higher odds of depression including burning sensation (OR 2.25, 95% CI 1.87-2.72, p < 0.001) compared to those without complaints. In both women with or without SS, the presence of symptoms of dry eyes and/or dry mouth rather than SS itself resulted in higher odds of depression. One particular ocular phenotypic feature of SS, a positive ocular staining score, was inversely correlated with depression.

CONCLUSIONS:
Participant-reported eye symptoms, particularly specific ocular sensations such as burning, were found to be positively associated with individual American College of Rheumatology/EUropean Union League Against Rheumatism (ACR/EULAR) SS criteria items.

MGD epidemiological study

This study looked at records of 1372 dry eye patients in Austria.

Couple of noteworthy highlights:

  • 70% of the patients had signs of MGD.

  • The patients with "pure" MGD LOOKED better (clinically) but FELT just as bad as patients with aqueous deficient dry eye (with or without MGD) or sjogrens.

Acta Ophthalmol. 2018 Apr 15. doi: 10.1111/aos.13732. [Epub ahead of print]
The prevalence of meibomian gland dysfunction, tear film and ocular surface parameters in an Austrian dry eye clinic population.
Rabensteiner DF1, Aminfar H1, Boldin I1, Schwantzer G2, Horwath-Winter J1.

Abstract

PURPOSE:
The purpose of this study was to assess the prevalence of meibomian gland dysfunction (MGD) and its association with tear film and ocular surface parameters in an Austrian clinical population of dry eye patients.

METHODS:
The records of 1372 consecutive patients from a dry eye unit were analysed retrospectively. Symptoms and objective tear film and ocular surface parameters were evaluated. Patients were classified into pure MGD, pure aqueous tear deficiency (ATD), MGD combined with ATD, pure anterior blepharitis (AB), Sjogren's syndrome (SS) without MGD and SS together with MGD.

RESULTS:
Nine-hundred and sixty-five patients, that is 70.3% of the investigated population, mean age 55.4 ± 16.6 years, had signs of MGD. Of these, 684 (70.9%) were female. The intensity of symptoms did not differ between subgroups. Four hundred and ninety (50.8%) MGD patients had Schirmer test values ≤10 mm/5 min. The fluorescein break-up time and Schirmer test values were significantly higher in the pure AB and MGD group. The pure MGD group showed a significantly lower fluorescein staining of the cornea compared to the other groups, except for pure AB. Lissamine green staining of the ocular surface was present in all groups, but was at least pronounced in the pure MGD and AB group.

CONCLUSION:
Meibomian gland dysfunction is a major cause of ocular discomfort and could often be found in combination with a reduced aqueous tear secretion. Although the intensity of subjective complaints was similar to all other subgroups, pure MGD exhibited the lowest severity of signs of ocular surface damage and also affected younger people.