The Ocular Surface

1 TFOS dews II Report Executive SummaryJennifer P. Craiga,1, J. Daniel Nelsonb,c,1, Dimitri T. Azard, Carlos Belmontee,f,Anthony J. Brong,h, Sunil K. Chauhani, Cintia S. de Paivaj, Jos e Gomesk,Katherine M. Hammittl, Lyndon Jonesm, Jason J. Nicholsn, Kelly K. Nicholsn,Gary D. Novacko,p, Fiona J. Stapletonq, Mark Willcoxq, James S. Wolffsohnr,David A. Sullivani,*aDepartment of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, Auckland, New ZealandbDepartment of Ophthalmology, HealthPartners Medical Group and Clinics, St Paul, MN, USAcDepartment of Ophthalmology, University of Minnesota, Minneapolis, USAdUniversity of Illinois at Chicago College of Medicine, Chicago, IL, USAeInstituto de Neurociencias de Alicante, University Miguel Hernandez-CSIC, SpainfInstituto Fernandez-Vega, Oviedo University, SpaingNuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UKhVision and Eye Research Unit, Anglia Ruskin University, Cambridge.

2 UKiSchepens Eye Research Institute, Massachusetts Eye and Ear, and Department of Ophthalmology, Harvard Medical School, Boston, MA, USAjDepartment of Ophthalmology, Baylor College of Medicine, Houston, TX, USAkDepartment of Ophthalmology and Visual Sciences, Federal University of Sao Paulo/Paulista School of Medicine, Sao Paulo, BrazillSj ogren's Syndrome Foundation, Bethesda, MD, USAmCentre for Contact Lens Research, School of Optometry and Vision Science, University of Waterloo, Waterloo, Ontario, CanadanUniversity of Alabama at Birmingham School of Optometry, Birmingham, AL, USAoPharma Logic Development, San Rafael, CA, USApDepartments of Pharmacology and Ophthalmology, University of California, Davis, School of Medicine, USAqSchool of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, AustraliarSchool of Life and Health Sciences, Aston University, Birmingham, UKarticle infoArticle history:Received 2 August 2017 Accepted 4 August 2017abstractThis article presents an Executive Summary of the conclusions and recommendations of the 10-chapterTFOS dews II report.

3 The entire TFOS dews II report was published in the July 2017 issue ofThe OcularSurface. A downloadable version of the document and additional material, including videos of diagnosticand management techniques, are available on the TFOS 2017 Elsevier Inc. All rights IntroductionDry eye disease (DED) affects hundreds of millions of peoplethroughout the world and is one of the most frequent causes ofpatient visits to eye care practitioners. It is a symptomatic disease,characterized by a vicious cycle of tearfilm instability and hyper-osmolarity, which leads to increased Ocular Surface inflammation,damage and neurosensory abnormalities. Moderate to severe DEDis associated with significant pain, limitations in performing dailyactivities, reduced vitality, poor general health, and increase our understanding of DED, the Tear Film&OcularSurface Society (TFOS), a non-profit organization, launched theTFOS Dry Eye Workshop II (TFOS dews II) in March 2015[1].

4 Thisinitiative reflected the TFOS mission, which is to advance theresearch, literacy, and educational aspects of the scientificfield ofthe tearfilm and Ocular Surface . The goal of the TFOS dews II was toachieve a global consensus concerning multiple aspects of specifically, TFOS dews II sought to: 1) Update the definitionand classification of DED; 2) Evaluate critically the epidemiology,pathophysiology, mechanism, and impact of this disorder; 3)Develop recommendations for the diagnosis, management andtherapy of this disease; and 4) Recommend the design of clinical*Corresponding author. Schepens Eye Research Institute, 20 Staniford Street,Boston, MA 02114, Sullivan).

5 1Co-first lists available atScienceDirectThe Ocular Surfacejournal 2017 Elsevier Inc. All rights Ocular Surface xxx (2017) 1e11 Please cite this article in press as: Craig JP, et al., TFOS dews II Report Executive Summary, The Ocular Surface (2017), to assess future interventions for DED TFOS dews II involved the efforts of 150 clinical and basicscience research experts from around the world, who utilized anevidence-based approach and a process of open communication,dialogue and transparency to increase our understanding of process required more than 2 years to entire TFOS dews II report was published in the July 2017issue ofThe Ocular Surface .

6 A downloadable version of the docu-ment and additional material, including videos of diagnosticand management techniques, are available on the TFOS It is anticipated that translations of the reportwill be offered in many languages, including, but not limited to,Chinese, French, German, Italian, Japanese, Korean, Polish, Portu-guese, Romanian, Spanish, Turkish and Vietnamese. These trans-lations, when completed, will be available on the TFOS Executive Summary of the conclusions and recommenda-tions of the TFOS dews II report is presented in this article. Thematerial is abstracted from the reports of ten TFOS dews II Sub-committees, which were Definition and Classification; Epidemi-ology; Sex, Gender, and Hormones; Pathophysiology; Tear Film;Iatrogenic Dry Eye; Pain and Sensation; Diagnostic Methodology;Management and Therapy; and Clinical Trial Design.

7 Additionaldetails and all references can be obtained in the open access, Definition and classification[2]The goals of the TFOS dews II Definition and ClassificationSubcommittee were to create an evidence-based definition and acontemporary classification system for DED. The new definition isas follows: Dry eye is a multifactorial disease of the Ocular Surface char-acterized by a loss of homeostasis of the tearfilm, and accom-panied by Ocular symptoms, in which tearfilm instability andhyperosmolarity, Ocular Surface inflammation and damage, andneurosensory abnormalities play etiological roles. The terminology in this definition, including diction, word order,emphasis, and accepted meaning, was critical in creating an inter-nationally accepted definition.

8 The term multifactorial disease recognizes DED as a significant and complex, functional disorderthat cannot be characterized by a single process, sign or term Ocular Surface is defined as comprising the structures ofthe Ocular Surface and adnexa, including the tearfilm, lacrimal andmeibomian glands, cornea, conjunctiva and eyelids. Homeostasis describes a state of dynamic equilibrium in the body with respect toits various functions, and to the chemical composition of thefluidsand tissues. Disruption of homeostasis is considered to be theunifying characteristic that encompasses the myriad of signs of tearfilm and Ocular Surface imbalance that might be observed in term symptoms embraces a broad range of possible patient-reported experiences associated with DED including, but notlimited to, discomfort and visual disturbance.

9 The key elementscontributing to the pathophysiological process, including tearfilminstability, hyperosmolarity, inflammation and damage, recognizedas etiological triggers of the vicious circle, were deemed important,along with neurosensory abnormalities, which have featuredincreasingly in the recent literature, for inclusion in the the classification of DED, the latest evidence supports ascheme based on its pathophysiology in which aqueous deficientdry eye (ADDE) and evaporative dry eye (EDE) exist as a continuum,such that elements of each need to be considered in diagnosis andmanagement. This approach is not intended to override clinicalassessment and judgment but to help guide clinical managementand future Subcommittee's recommended classification of DED isshown The upper portion of thefigure represents a clinicaldecision algorithm, beginning with the assessment of symptoms,and followed by review for signs of Ocular Surface disease.

10 DEDexhibits both symptoms and signs, and can be differentiated fromother Ocular Surface disease with the use of triaging questions andancillary testing. It is to this DED group that diagnostic subtyping,and conventional DED management strategies, apply. Symptomaticpatients without demonstrable clinical signs do not fall into theDED group, but are differentiated into pre-clinical Ocular surfacedisease or neuropathic pain (non- Ocular Surface disease).Conversely, asymptomatic patients exhibiting signs are differenti-ated into patients with poor corneal sensitivity, or those withprodromal signs, who may be at risk of developing manifest DEDwith time or provocation, for example following ophthalmic sur-gery or contact lensfitting.