Abstract
PurposeEvaluation of dry eye disease (DED) relies on subjective symptoms and signs. We examined HLA-DR expression (HLA-DR%) in conjunctival cells, a minimally invasive biomarker with objective metrics, as an alternative method.MethodsDry Eye Assessment and Management (DREAM) study participants completed the Ocular Surface Disease Index questionnaire. Clinicians evaluated tear volume, tear breakup time, and corneal and conjunctival staining. Conjunctival impression cytology samples (n = 1049) were assessed for HLA-DR% in total cells (TCs), epithelial cells (ECs), and white blood cells (WBCs). Associations (categorized into <5%, 5%–15%, >15%–25%, and >25%) with symptoms and signs were evaluated.ResultsThe HLA-DR% varied markedly across samples. Over 40% had <5 HLA-DR% positive cells in TCs and ECs and under 23% in WBCs. Higher HLA-DR% was associated with higher conjunctival staining for ECs (mean score 2.77 for <5% and 3.28 for >25%, linear trend P = 0.009) and TCs (mean score 2.82 for <5% and 3.29 for >25%, linear trend P = 0.04) and in TCs was associated with higher corneal staining (mean score 3.59 for <5% and 4.46 for >25%, linear trend P = 0.03). HLA-DR% in WBCs did not correlated with signs (all P ≥ 0.58), and in TCs, ECs or WBCs were not associated with symptoms (P > 0.06).ConclusionsThe distribution of HLA-DR% in conjunctival cells reflects the heterogeneity of disease in DREAM participants. High percentages of samples with <5% positive cells indicate that HLA-DR% may not be a sensitive marker for DED in all patients.Translational RelevanceHigh HLA-DR% in ECs in association with high conjunctival staining may identify a subgroup of DED patients prone to epithelial disease and possibly need a different approach from current standards of treatment.
Highlights
Dry eye disease (DED) is a common ocular condition with a worldwide prevalence ranging from 5% to 50%.1 As defined by the International Dry Eye Workshop in 2017: Dry eye is a multifactorial disease of the tears and ocular surface, that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface
The purpose of the present study was to determine the characteristics of ocular surface HLA-DR% by using stringently established and verified standard operating procedures (SOPs)[39] and to assess associations between ocular HLA-DR% levels and dry eye (DE) symptoms and signs in a well-characterized population of patients recruited for a multicenter, placebo-controlled, double-masked randomized clinical trial: The Dry Eye Assessment and Management (DREAM) study (Clinicaltrials.gov identifier NCT02128763).[42]
Data were analyzed for 527 patients because 7 patients had no IC samples collected and 1 had insufficient gated cells (,1000) for both eyes
Summary
Dry eye disease (DED) is a common ocular condition with a worldwide prevalence ranging from 5% to 50%.1 As defined by the International Dry Eye Workshop in 2017: Dry eye is a multifactorial disease of the tears and ocular surface, that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Dry eye disease (DED) is a common ocular condition with a worldwide prevalence ranging from 5% to 50%.1. As defined by the International Dry Eye Workshop in 2017: Dry eye is a multifactorial disease of the tears and ocular surface, that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.[2]. DED is common with advancing age, may complicate eye surgeries, and is considered an important risk factor for severe corneal complica-. The diagnosis of DED and the assessment of severity rely on symptoms from patient-reported questionnaires and signs based on clinical tests.[3,4] due to the multifactorial nature of DED, correlation between symptoms and signs is poor and inconsistent.[5,6,7,8] This has major implications on the development of reliable tools for diagnosis, classification, and measurement of treatment response
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