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Diagnostic accuracy of non-invasive tear film break-up time assessed by the simple manual interferometric device

Published:October 27, 2022DOI:https://doi.org/10.1016/j.clae.2022.101776

      Abstract

      Aim

      To determine the diagnostic accuracy of non-invasive tear film break-up time (NIBUT) measured by the handheld lipid layer examination instrument.

      Methods

      108 patients were enrolled in this cross-sectional study and divided into two groups: patients with dry eye (n = 57) categorized by the presence of dry eye symptoms obtained by Schein Questionnaire and minimally-one objective dry eye sign (tear film break-up time <10 s or corneal, conjunctival and lid margin fluorescein staining), and healthy subjects (n = 51).

      Results

      Dry eye subjects had significantly shorter NIBUT than healthy subjects (6 s vs 20 s, p < 0.001). Logistic regression analysis showed that shorter NIBUT values were excellent indicators of dry eye disease (p < 0.001), with consistency and no significant difference between measurements, even after standardizing the results for age and sex. NIBUT cut-off point to distinguish dry eye from healthy subjects was 12 s (sensitivity 90.2 %, specificity 88.5 %, PPV 92.5 %, NPV 85.2 %, LR +7.82, LR− 0.11, DOR 70.92, DE 89.6 %). Good, but lower accuracy was observed at cut-off value of 10 s (sensitivity 87.8 %, specificity 88.5 %, PPV 92.3 %, NPV 82.1 %, LR+ 7.61, LR− 0.14, DOR 55.2, DE 88.1 %). The area under the ROC curve (AUC) of 0.944 classified NIBUT as a diagnostic test with very high accuracy.

      Conclusion

      This study showed a high diagnostic accuracy of NIBUT measured by the handheld lipid layer examination instrument. This simple, reliable, objective and available instrument might regularly take place in routine, standard dry eye diagnostic and can be used by almost every eye specialist.

      Keywords

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      References

        • Craig J.P.
        • Nichols K.K.
        • Akpek E.K.
        • Caffery B.
        • Dua H.S.
        • Joo C.-K.
        • et al.
        TFOS DEWS II definition and classification report.
        Ocul Surf. 2017; 15: 276-283
        • Wolffsohn J.S.
        • Arita R.
        • Chalmers R.
        • Djalilian A.
        • Dogru M.
        • Dumbleton K.
        • et al.
        TFOS DEWS II diagnostic methodology report.
        Ocul Surf. 2017; 15: 539-574
        • Sweeney D.F.
        • Millar T.J.
        • Raju S.R.
        Tear film stability: a review.
        Exp Eye Res. 2013; 117: 27-38
      1. Tearscope. Tearscope Plus Clinical Handbook and Tearscope Plus Instructions. Windsor, Keeler Ltd, Windsor, Berkshire; Keeler Insts Inc., Broomall, PA, 1997.

        • Guillon J.P.
        Use of the Tearscope Plus and attachments in the routine examination of the marginal dry eye contact lens patient.
        Adv Exp Med Biol. 1998; 438: 859-867https://doi.org/10.1007/978-1-4615-5359-5_121
        • Tong L.
        • Teng L.S.
        Review of literature on measurements of non-invasive break up times, lipid morphology and tear meniscal height using commercially available handheld instruments.
        Curr Eye Res. 2018; 43: 567-575https://doi.org/10.1080/02713683.2018.1437454
        • Bandlitz S.
        • Pult H.
        Advances in tear film assessment.
        Optom Pract. 2016; 17: 81-90
        • Bandlitz S.
        • Peter B.
        • Pflugi T.
        • Jaeger K.
        • Anwar A.
        • Bikhu P.
        • et al.
        agreement and repeatability of four different devices to measure non-invasive tear breakup time (NIBUT).
        Cont Lens Anterior Eye. 2020; 43: 507-511
        • Tóth N.
        • Szalai E.
        • Rák T.
        • Lillik V.
        • Nagy A.
        • Csutak A.
        Reliability and clinical applicability of a novel tear film imaging tool.
        Graefes Arch Clin Exp Ophthalmol. 2021; 259: 1935-1943
        • Ward C.D.
        • Murchison C.E.
        • Petroll W.M.
        • Robertson D.M.
        Evaluation of the repeatability of the LacryDiag ocular surface analyzer for assessment of the meibomian glands and tear film.
        Transl Vis Sci Technol. 2021; 10: 1https://doi.org/10.1167/tvst.10.9.1
        • Remongin P.-E.
        • Rousseau A.
        • Best A.-L.
        • Ben Hadj Salah W.
        • Legrand M.
        • Benichou J.
        • et al.
        Place du NIBUT automatisé dans l’évaluation multimodale de la surface oculaire dans le syndrome sec avec le Lacrydiag.
        J Français d'Ophtalmol. 2021; 44: 313-320
        • Downie L.E.
        Automated tear film surface quality breakup time as a novel clinical marker for tear hyperosmolarity in dry eye disease.
        Invest Ophthalmol Vis Sci. 2015; 56: 7260-7268https://doi.org/10.1167/iovs.15-17772
        • Petriček I.
        Handheld tear film lipid layer thickness and non-invasive tear break up time assessment tool.
        J Clin Ophthalmol Eye Disord. 2017; 1: 1009
        • Vidas P.S.
        Non-invasive tear break-up time measurement using handheld lipid layer thickness assessment tool.
        University of Zagreb School of Medicine, 2019 (Doctoral thesis: Zagreb)
        • Vidas Pauk S.
        • Petriček I.
        • Jukić T.
        • Popović-Suić S.
        • Tomić M.
        • Kalauz M.
        • et al.
        Non-invasive tear film break-up time assessment using handheld lipid layer examination instrument.
        Acta Clin Croat. 2019; 58: 63-71https://doi.org/10.20471/acc.2019.58.01.09
        • Pauk S.V.
        • Petriček I.
        • Tomić M.
        • Bulum T.
        • Jandroković S.
        • Kalauz M.
        • et al.
        Manual interferometric device for routine non-invasive tear film break-up time assessment.
        Semin Ophthalmol. 2021; 36: 94-102
        • Schein O.D.
        • Tielsch J.M.
        • Munõz B.
        • Bandeen-Roche K.
        • Westet S.
        • al.
        Relation between signs and symptoms of dry eye in the elderly. A population-based perspective.
        Ophthalmology. 1997; 104: 1395-1401
        • Lemp M.A.
        • Foulks G.N.
        The definition and classification of dry eye disease: report of definition and classification subcommittee of international dry eye workshop.
        Ocul Surf. 2007; 5: 75-92
        • Bakija I.
        • Filipčić I.
        • Bogadi M.
        • Šimunović Filipčić I.
        • Gotovac M.
        • Kaštelan S.
        Comparison of the Schein and Osdi Questionnaire as Indicator of Tear Film Stability in Patients with Schizophrenia.
        Psychiatr Danub. 2021; 33: 596-603
        • Bandeen-Roche K.
        • Muñoz B.
        • Tielsch J.M.
        • West S.K.
        • Schein O.D.
        Self-reported assessment of dry eye in a population-based setting.
        Invest Ophthalmol Vis Sci. 1997; 38: 2469-2475
        • McDonald J.E.
        Surface phenomena of tear films.
        Trans Am Ophthalmol Soc. 1968; 66: 905-939
        • Norn M.S.
        Semiquantitative interference study of fatty layer of precorneal film.
        Acta Ophthalmol (Copenh). 1979; 57: 766-774
        • Vigo L.
        • Pellegrini M.
        • Bernabei F.
        • Carones F.
        • Scorcia V.
        • Giannaccare G.
        • et al.
        Diagnostic performance of a novel non-invasive workup in the setting of dry eye disease.
        J Ophthalmol. 2020; 2020: 1-6
        • Hong J.
        • Sun X.
        • Wei A.
        • Cui X.
        • Li Y.
        • Qian T.
        • et al.
        Assessment of tear film stability in dry eye with a newly developed keratograph.
        Cornea. 2013; 32: 716-721
        • Mengher L.S.
        • Pandher K.S.
        • Bron A.J.
        Non-invasive tear film break-up time: sensitivity and specificity.
        Acta Ophthalmol (Copenh). 1986; 64: 441-444https://doi.org/10.1111/j.1755-3768.1986.tb06950.x
        • Wang H.F.
        • Fukuda M.
        • Shimomura Y.
        Diagnosis of dry eye.
        Semin Ophthalmol. 2005; 20: 53-62https://doi.org/10.1080/08820530590931115
        • Gumus K.
        • Crockett C.H.
        • Rao K.
        • Yeu E.
        • Weikert M.P.
        • Shirayama M.
        • et al.
        Non-invasive assessment of tear stability with the tear stability analysis system in tear dysfunction patients.
        Invest Ophthalmol Vis Sci. 2011; 52: 456
        • Bhandari V.
        • Reddy J.K.
        • Relekar K.
        • Ingawale A.
        • Shah N.
        Non-invasive assessment of tear film stability with a novel corneal topographer in Indian subjects.
        Int Ophthalmol. 2016; 36: 781-790https://doi.org/10.1007/s10792-016-0186-7
        • Pult H.
        • Purslow C.
        • Murphy P.J.
        The relationship between clinical signs and dry eye symptoms.
        Eye (Lond). 2011; 25: 502-510https://doi.org/10.1038/eye.2010.228
        • Guillon M.
        • Styles E.
        • Guillon J.P.
        • Maïssa C.
        • Guillon M.
        Preocular tear film characteristics of nonwearers and soft contact lens wearers.
        Optom Vis Sci. 1997; 74: 273-279
        • Versura P.
        • Campos E.C.
        TearLab® Osmolarity System for diagnosing dry eye.
        Expert Rev Mol Diagn. 2013; 13: 119-129https://doi.org/10.1586/erm.12.142