@article{d39ecfa61e804049b0f5cd0775d80ac2,
title = "TFOS DEWS II Diagnostic Methodology report",
abstract = "The role of the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS) II Diagnostic Methodology Subcommittee was 1) to identify tests used to diagnose and monitor dry eye disease (DED), 2) to identify those most appropriate to fulfil the definition of DED and its sub-classifications, 3) to propose the most appropriate order and technique to conduct these tests in a clinical setting, and 4) to provide a differential diagnosis for DED and distinguish conditions where DED is a comorbidity. Prior to diagnosis, it is important to exclude conditions that can mimic DED with the aid of triaging questions. Symptom screening with the DEQ-5 or OSDI confirms that a patient might have DED and triggers the conduct of diagnostic tests of (ideally non-invasive) breakup time, osmolarity and ocular surface staining with fluorescein and lissamine green (observing the cornea, conjunctiva and eyelid margin). Meibomian gland dysfunction, lipid thickness/dynamics and tear volume assessment and their severity allow sub-classification of DED (as predominantly evaporative or aqueous deficient) which informs the management of DED. Videos of these diagnostic and sub-classification techniques are available on the TFOS website. It is envisaged that the identification of the key tests to diagnose and monitor DED and its sub-classifications will inform future epidemiological studies and management clinical trials, improving comparability, and enabling identification of the sub-classification of DED in which different management strategies are most efficacious.",
keywords = "DEWS, Diagnosis, Dry eye disease (DED), Dry Eye Workshop, Methodology, Monitoring, Questionnaires, Sub-classification of dry eye, Tests for dry eye",
author = "Wolffsohn, {James S.} and Reiko Arita and Robin Chalmers and Ali Djalilian and Murat Dogru and Kathy Dumbleton and Gupta, {Preeya K.} and Paul Karpecki and Sihem Lazreg and Heiko Pult and Sullivan, {Benjamin D.} and Alan Tomlinson and Louis Tong and Edoardo Villani and Yoon, {Kyung Chul} and Lyndon Jones and Craig, {Jennifer P.}",
note = "Funding Information: For questionnaires that are additionally intended as outcome measures for registration studies at the US Food and Drug Administration (FDA), an FDA guidance document describes a path for the development of a Patient Reported Outcome (PRO) [84]. For most DED research and clinical care, the majority of symptom tools focus primarily on the measurement of symptoms associated with DED, and these instruments, while valid, do not follow the full psychometric development plan for PROs. However, even for symptom questionnaires that are not supporting FDA claims, it is critical that they be validated for their discriminative ability. It should also be noted that validation is generally using patient groups with Sjogren Syndrome versus non-Sjogren Syndrome ADDE and/or healthy controls, with little focus on EDE. A recent thorough review by Guillemin and co-workers in 2012 covers the topic of questionnaire validation, and strengths and weaknesses of many DED questionnaires [85]. Funding Information: J. Wolffsohn: Alcon, Aston EyeTech, Bausch & Lomb, BetterVision Ltd, CooperVision, Eaglet Eye, European Union, Eyebag, EMPharma, EyeDocs, Gelflex, Innovate UK, Johnson & Johnson Vision Care, Lenstec, Medmont, Rayner, Th{\'e}a, Optimec, Visioncare Research (F); Aston EyeTech (I); British Contact Lens Association, University of Houston, Visioncare Research, CooperVision (C); Portable Aberrometer, Contrast Sensitivity Chart (P); Johnson & Johnson (R) R. Arita: TearScience (F); Japan Fiocus Corp, Kowa (C); Topcon (P) R. Chalmers: Johnson & Johnson Vision Care (F); Alcon, AcuFocus; CooperVision (C); Contact Lens & Anterior Eye/Assoc. Editor (S) A. Djalilian: None. M. Dogru: Santen (F), Otsuka (F) K. Dumbleton: Alcon, CooperVision, Johnson & Johnson Vision Care (C) P. Gupta: Allergan, Bio-Tissue, Inc., Alcon, AMO, Novabay, Ocular Science, Shire, TearLab, TearScience (C) P. Karpecki: Rigel Pharma (F); Akorn, Allergan, Bausch + Lomb (F, C); AMO, Alcon, Beaver-Visitech, BioTissue, Blephex, Bruder Healthcare, Cambria Pharmaceuticals, Eye Brains, Focus Laboratories, Glaukos, iCare USA, Johnson & Johnson Vision Care, Katina, Konan Medical, Oculus, Ocusoft, Paragon Bioteck, Reichert, Rendia, Science Based Health, Shire Pharmaceuticals, Sun Pharmaceutical, Tearfilm Innovations, TearLab, TearScience, Topcon, Visiometrics (C) S. Lazreg: None. H. Pult: Johnson & Johnson Vision Care (F) B.D. Sullivan: TearLab, Lubris (I, E, P, R, S) A. Tomlinson: None. L. Tong: Alcon (C, R); Allergan (F, R); Santen (F); W02013/109193 Computer vision based approach for the assessment of the health and anatomy of eyelids and ocular surface disease using meibography (P); Santen (R) E. Villani: None. K. C. Yoon: None. L. Jones: Advanced Vision Research, Alcon, AlgiPharm, Allergan, CooperVision, Essilor, Johnson & Johnson, Ocular Dynamics, Oculus, TearScience, Visioneering Technologies (F); Alcon, Johnson & Johnson Vision Care (C); Alcon, CooperVision, Johnson & Johnson (R) J. P. Craig Oculeve, Allergan, Manuka Health NZ, E-Swin, CooperVision, Alcon, Optima Pharmaceuticals, OPSM NZ, Akorn, TearScience, Medmont (F); Carl Zeiss Meditec, Eye Institute Auckland (C) F (Financial Support), I (Personal Financial Interest), E (Employment), C (Consultant), P (Patent), R (Recipient), N (No Commercial Relationship), S (non-remunerative). ",
year = "2017",
month = jul,
doi = "10.1016/j.jtos.2017.05.001",
language = "English",
volume = "15",
pages = "539--574",
journal = "Ocular Surface",
issn = "1542-0124",
publisher = "Elsevier Inc.",
number = "3",
}