DEWS Ep Id E M Io Lo G Y
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DEWS Ep id e m io lo g y T h e Ep id e m io lo g y o f D r y Eye D is e a s e : Report of the Epidemiology Subcommittee of the In tern a tion a l D ry Eye W ork Shop (2 0 0 7 ) ABSTRACT The report of the Epidemiology Subcommit- population and the factors that influence the distribution tee of the 2 0 0 7 Dry Eye WorkShop summarizes current of the disease in the population and its subgroups can be knowledge on the epidemiology of dry eye disease, providing identified through epidemiologic study. prevalence and incidence data from various populations. It In the mid-1990s, the extent of the dry eye problem stresses the need to expand epidemiological studies to ad- worldwide was poorly understood. A workshop co-spon- ditional geographic regions, to incorporate multiple races sored by the National Eye Institute (NEI) and Industry and ethnicities in future studies, and to build a consensus brought together some of the leading scientists in ocular on dry eye diagnostic criteria for epidemiological studies. surface research and concluded that, “There is a paucity Recommendations are made regarding several characteristics of data concerning the frequency of dry eye states in the of dry eye questionnaires that might be suitable for use in population and how that frequency varies according to epidemiological studies and randomized controlled clinical age, sex and race.”1 trials. Risk factors for dry eye and morbidity of the disease Considerable progress has been made since 1994 and are identified, and the impact of dry eye disease on quality of multiple reports have been published that address the life and visual function are outlined. Suggestions are made for challenge of providing epidemiological data on dry eye, further prospective research that would lead to improvement including data from the Salisbury Eye Evaluation, the of both eye and general public health. Beaver Dam Eye Study, the Melbourne V isual Impairment Project, and the W omen’s Health Study and Physicians’ KEY WORDS DEWS, dry eye, Dry Eye WorkShop, Health Study, among others. It is the purpose of this report epidemiology, risk factors, questionnaire to summarize the available evidence on the epidemiology of dry eye disease and to make recommendations for future I. INTRODUCTION needs and research opportunities. pidemiology is the branch of biomedical research that involves the study of the distribution and II. GOALS OF THE EPIDEMIOLOGY E determinants of health and disease in human SUBCOMMITTEE populations. The frequencies and types of disease in a The goals of the Epidemiology Subcommittee of the 2007 Dry Eye W orkShop (DEWS) were 1) to assess and summarize current knowledge on the epidemiology of dry eye, obtaining prevalence and incidence data from various Accepted for publication January 2007. populations, 2) to describe the risk factors for dry eye, and Epidemiology DEW S Subcommittee: Janine A. Smith , M D (C h air); Julie Al- 3) to review and evaluate dry eye questionnaires. beitz, PhD; Carolyn Begley, OD, PhD; Barbara Caffery, OD, MS; K elly Nichols, OD, MPH, PhD; Debra Schaumberg, ScD, OD, MPH; Oliver Schein, MD. A. Goal 1: Assess and Summarize Current Knowledge Proprietary interests of Subcommittee members are disclosed on pages 202 on the Epidemiology of Dry Eye Disease and 204. 1. Dry Eye Definitions and Ascertainment Reprints are not available. Articles can be accessed at: www.tearfilm.org To characterize the prevalence of a disease (ie, the pro- Correspondence in regard to the DEW S Report should be addressed to: Janine A. Smith, MD, NEI, NIH, 10 Center Drive, MSC 1204, Bethesda, MD 20892. portion with disease within a population at a given point Tel: 301-496-9058. Fax: 301-496-7295. Email: [email protected] in time) or its incidence (ie, the number of new cases of disease that emerge from a population of initially disease- free individuals over a defined period of time), it is neces- ©2007 Ethis Communications, Inc. The Ocular Surface ISSN: 1542- sary to agree upon a definition. Dry eye is a multifactorial 0124. (No authors listed). The epidemiolog y of dry eye disease: disease that can result from and present in a variety of ways. report of the Epidemiolog y Subcommittee of the International Dry In 1995, the NEI/Industry workshop broadly defined dry Eye W orkShop (2007). 2007;5(2):93-107. eye as “a disorder of the tear film due to tear deficiency THE OCULAR SURF ACE / APRIL 2007, VOL. 5, NO. 2 / www.theocularsurface.com 93 DEWS EPIDEMIOLOGY OUTLINE or excessive tear evaporation which causes damage to the interpalpebral ocular surface associated with symptoms of I. Introduction ocular discomfort.”1 In this definition, the term tear defi- II. Goals of the Epidemiology Subcommittee cien cy implied a deficiency of aqueous tears secreted by the A. Goal 1: Assess and summarize current lacrimal gland. The requirement of symptoms in the defini- knowledge on the epidemiology of dry eye tion is noteworthy, as it was not included in the definitions disease established in all nations; for instance, it was absent from 1. Dry eye definitions and ascertainment the Japanese definition of dry eye until recently.2 2. Challenges in dry eye epidemiology 3. Summary of dry eye epidemiology data 2. Challenges in Dry Eye Epidemiology a. Prevalence of dry eye No single diagnostic test can be performed in the field 1) Combined prevalence data or in the clinic to reliably distinguish individuals with 2) Discussion/comments and without dry eye. Furthermore, although a variety of b. Incidence of dry eye diagnostic tests are in common clinical usage, there is no c. Natural history consensus on which combination of tests should be used d. Effects of magnitude of prevalence of to define the disease, either in the clinic or for the purposes disease in population on positive and of a research protocol. A major stumbling block has been negative predictive value the reported lack of correlation between patients’ irritative 4. Morbidity of dry eye ocular symptoms and the results of selected clinical tests a. Financial costs of dry eye for dry eye. Much of this discrepancy can be explained b. Impact of dry eye on quality of life by the lack of repeatability of many of the clinical tests in c. Burden of dry eye common use, with the implication that repeated measures d. Quality of Life in Sjogren syndrome of the same test on the same subjects at different times are e. Impact on visual function not strongly correlated. Thus, it is not unexpected that such f. Ocular morbidity associated with dry eye tests will fail to correlate with each other. g. Future research directions Another plausible reason for a lack of correlation be- B. Goal 2: Describe the risk factors for dry eye tween clinical tests and irritative symptoms may be the nat- 1. Bone marrow transplantation and cancer ural variability of the disease process, the “subjective” nature of symptoms, and variability in pain thresholds and cogni- 2. Menopausal hormone therapy (MHT) tive responses to questions about the physical sensations in 3. Sex hormones the eyes. Other factors could include the development of 4. Essential fatty acids relative corneal anesthesia with aging and with worsening 5. Low humidity environments disease, and the possibility that symptoms are related to 6. Computer use parameters not measured by the tests currently employed. 7. Contact lens wear Dry eye is a symptomatic disease, and, at the present 8. Refractive surgery time, symptom questionnaires are among the most repeat- C. Goal 3: Review of Dry Eye Questionnaires able of the commonly used diagnostic tests. They may 1. Features of dry eye questionnaires provide a more integrated view of the clinical condition a. McMonnies Dry Eye History Questionnaire over time. Irritative symptoms are largely responsible for the b. Canadian Dry Eye Epidemiology Study public health burden and for the care-seeking behavior of (CANDEES) dry eye patients and their desire for therapy. Dry eye symp- c. Ocular Surface Disease Index (OSDI) toms also affect activities of daily living, adversely impact- d. Impact of Dry Eye on Everyday Life (IDEEL) ing important tasks such as driving. With these important e. Salisbury Eye Evaluation Questionnaire issues in mind, it should be noted that individual research f. Dry Eye Epidemiology Project groups in various reports have used different operational Questionnaire definitions of dry eye that are appropriate for their par- g. Women’s Health Study Questionnaire ticular purpose. It is of great importance to consider these h. National Eye Institute-Visual Function differences when interpreting and comparing such studies. Questionnaire (NEI-VFQ) The Subcommittee examined data from a number of i. Dry Eye Questionnaire (DEQ) and Contact large cohort studies and paid particular attention to defini- Lens DEQ tions employed and criteria used, including the require- j. Melbourne, Australia, Visual Impairment ment for a certain number, frequency, and intensity of Project Questionnaire symptoms. It was also noted whether a clinical examina- 2. Summary tion was performed, or whether the study diagnosis was 3. Future Research based on the history of dry eye diagnosed by a clinician. III. Conclusions In some cases, measurements from objective tests were recorded, such as tear production, staining of the ocular 94 THE OCULAR SURFACE / APRIL 2007, VOL. 5, NO. 2 / www.theocularsurface.com DEWS EPIDEMIOLOGY Table 1. Summary of population-based epidemiologic studies of dry eye Study N Age range Dry eye assessment Prevalence US Studies Salisbury Eye Study3-5 2420 r 65 y At least 1 of 6 symptoms (dryness, 14.6% gritty/sandiness, burning, redness, crusting on lashes, eyes stuck shut in morning), occurring at least often.