Methodologies to Diagnose and Monitor Dry Eye Disease: Report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop (2007)

doi:10.1016/S1542-0124(12)70083-6

The Ocular Surface

Volume 5, Issue 2, April 2007, Pages 108-152

https://doi.org/10.1016/S1542-0124(12)70083-6 Get rights and content

Abstract

The role of the Diagnostic Methodology Subcommittee of the Dry Eye Workshop was 1) to identify tests used to screen, diagnose and monitor dry eye disease, 2) to establish criteria for test performance, and 3) to consider the utility of tests in a variety of clinical settings. The committee created a database of tests used to diagnose and monitor dry eye, each compiled by an expert in the field (rapporteur) and presented within a standard template. Development of the templates involved an iterative process between the Chairman of the subcommittee, the rapporteurs, and, at times, an additional group of expert reviewers. This process is ongoing. Each rapporteur was instructed on how to the complete a template, using a proforma template and an example of a completed template. Rapporteurs used the literature and other available sources as the basis for constructing their assigned template. The Chairman of the subcommittee modified the template to produce a standardized version and reviewed it with the rapporteur. The completed database will be searchable by an alphabetical list of test names, as well as by functional groupings, for instance, tests of aqueous dynamics, lipid functions, etc. The templates can be accessed on the website of the Tear Film and Ocular Surface Society (www.teafiilm.oig). This report provides a general overview of the criteria applied in the development of tests for screening and diagnosis.

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Some systemic medications are reported to be associated with dry eye disease (DED), yet their associations with the severity of DED signs and symptoms are not well studied. To evaluate these associations, we performed a secondary analysis of data from the DRy Eye Assessment and Management (DREAM) Study.
Participants (N = 535) were assessed for DED signs using tear break-up time (TBUT), Schirmer testing, corneal fluorescein staining, conjunctival lissamine green staining, meibomian gland dysfunction (MGD), and tear osmolarity and DED symptoms using the Ocular Surface Disease Index (OSDI). We derived a composite signs severity score from the 6 DED signs and categorized participant-reported systemic medications into antidepressants, antihistamines, aspirin, corticosteroids, diuretics, nonsteroidal anti-inflammatory drugs, proton pump inhibitors, statins, vitamin D3, and medications for diabetes mellitus, hypertension, hypothyroidism, migraine, and seizure. Generalized linear models were used to compare DED symptom and sign scores between medication users and non-users, with adjustment for factors associated with DED severity.
Compared to non-users, antihistamine users had lower TBUT (p = 0.01) and higher OSDI score (p = 0.02); aspirin users had lower TBUT (p = 0.02); corticosteroid users had lower TBUT (p = 0.02), lower Schirmer test scores (p = 0.03), higher cornea fluorescein staining (p = 0.01), higher composite severity score (p = 0.01), and higher OSDI score (p = 0.03); seizure medication users had higher composite severity score (p = 0.02); vitamin D3 users had lower TBUT (p = 0.001) and greater MGD (p = 0.03); and diuretic users had less MGD (p = 0.03).
Certain systemic medications may be associated with more severe DED. This may guide prescription practices in patients with DED.
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To assess the therapeutic effect of tinted lenses (FL-41) on photophobia and light-evoked brain activity using functional magnetic resonance imaging (fMRI) in individuals with chronic ocular surface pain.
Prospective case series.
25 subjects from the Miami veterans affairs (VA) eye clinic were recruited based on the presence of chronic ocular pain, dry eye symptoms, and photophobia. Using a 3T MRI scanner, subjects underwent 2 fMRI scans using an event-related design based on light stimuli: one scan while wearing FL-41 lenses and one without. Unpleasantness ratings evoked by the light stimuli were collected after each scan.
With FL-41 lenses, subjects reported decreased (n = 19), maintained (n = 2), or increased (n = 4) light-evoked unpleasantness ratings. Group analysis at baseline (no lens) revealed significant light evoked responses in bilateral primary somatosensory (S1), bilateral secondary somatosensory (S2), bilateral insula, bilateral frontal pole, visual, precuneus, paracingulate, and anterior cingulate cortices (ACC) as well as cerebellar vermis, bilateral cerebellar hemispheric lobule VI, and bilateral cerebellar crus I and II. With FL-41 lenses, light-evoked responses were significantly decreased in bilateral S1, bilateral S2, bilateral insular, right temporal pole, precuneus, ACC, and paracingulate cortices as well as bilateral cerebellar hemispheric lobule VI.
FL-41 lenses modulated photophobia symptoms in some individuals with chronic ocular pain. In conjunction, FL-41 lenses decreased activation in cortical areas involved in processing affective and sensory-discriminative dimensions of pain. Further research into these relationships will advance the ability to provide precision therapy for individuals with ocular pain.
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To conduct a genome-wide association study (GWAS) of individuals with neuropathic ocular pain (NOP) symptoms to identify genomic variants that may predispose to NOP development.
Prospective study of individuals with NOP.
Three hundred twenty-nine patients recruited from the Miami Veterans Affairs eye clinic.
The Neuropathic Pain Symptom Inventory modified for the eye (NPSI-Eye) was completed to calculate a NPSI-Eye-Sub-Score (summed ratings of burning and wind sensitivity) as an indicator of NOP severity. A GWAS was performed for the NPSI-Eye-Sub-Score with a significance threshold of P < 5 × 10⁻⁸. A gene-based analysis was performed using the multimarker analysis of genomic annotation software (in the functional mapping and annotation of GWAS online platform). The 13 865 778 single nucleotide polymorphisms (SNPs) from our GWAS analysis were mapped to 10 834 protein coding genes, and significant genes were run through gene set enrichment analysis.
Identification of SNPs and protein products that may be associated with the development of NOP.
One hundred seventy-one SNPs reached a threshold of P < 10⁻⁵, of which 10 SNPs reached the suggestive level of significance of P < 5 × 10⁻⁷ and 1 SNP met our genome-wide significance threshold of P < 5 × 10⁻⁸. This lead SNP, rs140293404 (P = 1.23 × 10⁻⁸), is an intronic variant found within gene ENSG00000287251 coding for transcript ENST00000662732.1. Rs140293404 is in linkage disequilibrium with exon variant rs7926353 (r2 > 0.8) within ENSG00000279046 coding for transcript ENST00000624288.1. The most significant genes from gene-based tests were matrix metalloproteinase-19 (MMP19) (P = 1.12 × 10⁻⁵), zinc finger RNA-binding motif and serine/arginine rich-1 (ZRSR1) (P = 1.48 × 10⁻⁴), CTC-487M23.8 (P = 1.79 × 10⁻⁴), receptor expression-enhancing protein-5 (REEP5) (P = 2.36 × 10⁻⁴), and signal recognition particle-19 (SRP19) (P = 2.56 × 10⁻⁴). From gene set enrichment analysis, the sensory perception (false discovery rate = 6.57 × 10⁻³) and olfactory signaling (false discovery rate = 1.63 × 10⁻²) pathways were enriched with the most significant genes.
Our GWAS revealed genes with protein products that may impact sensory perception, lending biological plausibility to a role for SNPs identified by our GWAS in the development of NOP. A better understanding of the biological relevance of these genes and pathways in the pathophysiology associated with NOP may facilitate future novel mechanism-based treatments.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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To assess which signs and eye prosthesis care habits are related to subjective discomfort in patients with dry anophthalmic socket syndrome (DASS), using standardized tools from daily practice.
62 anophthalmic sockets were compared with their healthy fellow eye using the Standard Patient Evaluation of Eye Dryness (SPEED) score. The correlations between SPEED questionnaire and the prosthesis care, discharge characteristics score, conjunctival inflammation score, meibomian gland dysfunction (MGD) scores and Schirmer I test were studied.
The anophthalmic sockets group achieved a higher SPEED test score (p < 0.01), discharge score (p < 0.01), conjunctival inflammation score (p < 0.01), MGD scores (p < 0.01) and lower Schirmer I test (p < 0.01) compared with their fellow, healthy eye. Patients with a prosthesis replacement of one year or less, those with a current fit time of one year or less and those with a cleaning frequency above one month reported better SPEED, (p < 0.01), conjunctiva inflammation (p < 0.01) and MGD scores (p < 0.01).
Most anophthalmic patients suffer mild to severe DASS, which seems related to discharge, conjunctival inflammation and MGD. Moreover, certain practices related to the care of the prosthesis such as replacing with a frequency lower than yearly, current fitting time inferior to one year and a removing and cleaning regime above one month, were related to a lower discomfort sensation, conjunctival inflammation and MGD. Clinicians should consider the DASS when facing patients with anophthalmic socket and discomfort symptoms.
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Individuals with persistent ocular pain after refractive surgery.
The 109 patients who underwent refractive surgery were followed up for 6 months after surgery. Mean age was 34 ± 8 years (range, 23–57 years); 62% self-identified as female, 81% as White, and 33% as Hispanic. Eight patients (7%) reported ocular pain (NRS score ≥ 3) before surgery, with the frequency of ocular pain increasing after surgery to 23% (n = 25) at 3 months and 24% (n = 26) at 6 months. Twelve patients (11%) reported an NRS score of 3 or more at both time points and constituted the persistent pain group. Factors that predicted persistent pain after surgery in a multivariable analysis were (1) ocular pain before surgery predicated persistent pain after surgery (odds ratio [OR], 1.87; 95% confidence interval [CI], 1.06–3.31), (2) symptom report of depression before surgery (Patient Health Questionnaire-9: OR, 1.3; 95% CI, 1.1–1.6; P = 0.01), (3) use of an oral antiallergy medication before surgery (OR, 13.6; 95% CI, 2.1–89.3; P = 0.007), and (4) pain intensity day 1 after surgery (OR, 1.6; 95% CI, 1.2–2.2; P = 0.005). There were no significant associations between ocular surface signs of tear dysfunction and ocular pain, P > 0.05 for all ocular surface signs. Most individuals (> 90%) were completely or somewhat satisfied with their vision at 3 and 6 months.
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Proprietary or commercial disclosure may be found after the references.
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Diagnostic Methodology Subcommittee members: Anthony J. Bron, FCOphth, FMedSci (Chair), Diagnostic Tests Section: Anthony J. Bron, FCOphth (Captain); Mark B. Abelson, MD; George Ousler, BS; E. Pearce, PhD; Alan Tomlinson, PhD, DSc; Norihiko Yokoi, MD, PhD. Symptoms Section: Janine A. Smith, MD (Captain); Carolyn Begley, OD; Barbara Caffery, OD; Kelly Nichols, PhD; MD; Debra Schaumberg, PhD; Oliver Schein, MD, MPH, MBA. Emerging Technologies Section: Margarita Calonge, MD (Captain); Christophe Baudouin, MD, PhD; Eiki Goto, MD; Franz Grus, MD, PhD; Jerry Paugh, PhD, OD.

Writing Team Coordinator: Debra Schaumberg, PhD.

Particular thanks are due Prof. Alan Tomlinson for his seminal contributions to this report.

Proprietary interests of Subcommittee members are disclosed on pages 202 and 204.

Reprints are not available. Articles can be accessed at: www.tearfilm.org.

Correspondence related to this chapter of the DEWS Report should be directed to: Anthony Bron, FMedSci, FRCS, Nuffield Laboratory of Ophthalmology, Walton St., Oxford OX2 6AW, UK. Email: [email protected]

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DEWS Diagnostic MethodologyMethodologies to Diagnose and Monitor Dry Eye Disease: Report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop (2007)

Abstract

Am J Ophthalmol

Ophthalmic Physiol Opt

Am J Ophthalmol

Ophthalmology

Exp Eye Res

Ophthalmic Physiol Opt

Am J Ophthalmol

Ophthalmology

Ophthalmology

Ocul Surf

Am J Ophthalmol

Am J Ophthalmol

Ocul Surf

Definition and Classification of Dry Eye. Report of the Diagnosis and Classification Subcommittee of the Dry Eye WorkShop (DEWS)

Ocul Surf

Classification criteria for Sjogren's syndrome–sensitivity and specificity of criteria of the Japanese Ministry of Health and Welfare (1977) and criteria of European community (1993)

Nippon Rinsho

Report of National Eye Institute/Industry Workshop on clinical trials in dry eyes

CLAO J

Dysfunctional tear syndrome: A Delphi pproach to reatment ecommendations

Cornea

Classification criteria for Sjogren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group

Ann Rheum Dis

Responses to a dry eye questionnaire from a normal population

J Am Optom Assoc

A comparison of diagnostic tests for keratoconjunctivitis sicca: lactoplate, Schirmer, and tear osmolarity

CLAO J

Diagnostic tests in the sicca syndrome

Arch Ophthalmol

The European Community Study Group on diagnostic criteria for Sjogren's syndrome. Sensitivity and specificity of tests for ocular and oral involvement in Sjogren's syndrome

Ann Rheum Dis

A non-invasive instrument for clinical assessment of the pre-corneal tear film stability

Curr Eye Res

Tear film stability analysis system: introducing a new application for videokeratography

Cornea

Tear meniscus measurement in the diagnosis of dry eye

Curr Eye Res

Relationship between tear volume and tear meniscus curvature

Arch Ophthalmol

Tear Function Index A New Measure of Dry Eye

Arch Ophthalmol

Tear osmolarity–a new gold standard?

Adv Exp Med Biol

Tear filmosmolarity: determination of a referent value for dry eye diagnosis

Invest Ophthalmol Vis Sci

4th International Conference on the Lacrimal Gland, Tear Film & Ocular Surface and Dry Eye Syndromes

Adv Exp Med Biol

DEWS Diagnostic Methodology
Methodologies to Diagnose and Monitor Dry Eye Disease: Report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop (2007)