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. 2021 Apr 1;10(4):28.
doi: 10.1167/tvst.10.4.28.

Smart Eye Camera: A Validation Study for Evaluating the Tear Film Breakup Time in Human Subjects

Eisuke Shimizu  1   2 , Hiroyuki Yazu  1   2   3 , Naohiko Aketa  1   2 , Ryota Yokoiwa  2 , Shinri Sato  1 , Taiichiro Katayama  1 , Akiko Hanyuda  1 , Yasunori Sato  4 , Yoko Ogawa  1 , Kazuo Tsubota  1
Affiliations

Smart Eye Camera: A Validation Study for Evaluating the Tear Film Breakup Time in Human Subjects

Eisuke Shimizu et al. Transl Vis Sci Technol. .

Abstract

Purpose: This study aimed to demonstrate the efficacy of a "Smart Eye Camera (SEC)" in comparison with the efficacy of the conventional slit-lamp microscope by evaluating their diagnostic functionality for dry eye disease (DED) in clinical cases.

Methods: This retrospective study included 106 eyes from 53 adult Japanese patients who visited the Ophthalmology outpatient clinics in Keio University Hospital from June 2019 to March 2020. Tear film breakup time (TFBUT) and corneal fluorescence score (CFS) measurements for the diagnosis of DED were compared between the conventional slit-lamp microscope and SEC.

Results: The objective findings of DED showed that there was a strong correlation between the conventional slit-lamp microscope and SEC with respect to TFBUT and CFS results (Spearman's r = 0.887, 95% confidence interval [CI] = 0.838-0.922, and r = 0.920, 95% CI = 0.884-0.945, respectively). The interobserver reliability between the conventional slit-lamp microscope and SEC showed a moderate agreement (weighted Kappa κ = 0.527, 95% CI = 0.517-0.537 and κ = 0.550, 95% CI = 0.539-0.561 for TFBUT and CFS, respectively). The diagnostic performance of the SEC for Asia Dry Eye Society diagnostic criteria showed a sensitivity of 0.957 (95% CI = 0.841-0.992), specificity of 0.900 (95% CI = 0.811-0.927), positive predictive value of 0.880 (95% CI = 0.774-0.912), and negative predictive value of 0.964 (95% CI = 0.869-0.993). Moreover, the area under the receiver operating characteristic curve was 0.928 (95% CI = 0.849-1.000).

Conclusions: Compared with the conventional slit-lamp microscope, SEC has sufficient validity and reliability for diagnosing DED in the clinical setting.

Translational relevance: The SEC can portably evaluate TFBUT in both basic research and clinical care.

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Conflict of interest statement

Disclosure: E. Shimizu, OUI Inc. (P), The Japan Agency for Medical Research and Development (F), Uehara Memorial Foundation (F), Hitachi Global Foundation (F), Kondo Memorial Foundation (F), Eustylelab (F), Kowa Memorial Foundation (F); H. Yazu, OUI Inc. (P), Casio Science Promotion Foundation (F); N. Aketa, OUI Inc. (P); R. Yokoiwa, OUI Inc. (P); S. Sato, None; T. Katayama, None; A. Hanyuda, None; Y. Sato, None; Y. Ogawa, Kissei Pharmaceutical (P), Alcon (F); K. Tsubota, Tsubota lab (R), JIN (F), Santen (F), Kowa (F), Otsuka Pharmaceutical (F), Rohto Pharmaceutical (F) Fuji Xerox (F), Sucampo Pharma (F), Ophtecs (F) Wakasa Seikatsu (F), Pfizer (F), Alcon (F), QD laser (F) Kao Corporation (R), Thea (R, P)

Figures

Figure 1.
Figure 1.
Characteristics of the Smart Eye Camera (SEC) invented for the evaluation of dry eye disease. (A) The hardware, which contains the basal component which fits into the iPhone 7. The blue filter fits above the light source, and a convex macro lens is placed above the camera. (B) The SEC equipped to the iPhone 7. (C) The recording interfaces.
Figure 2.
Figure 2.
Comparison of the visual characteristics of dry eye disease between the slit-lamp microscope and the Smart Eye Camera. Clinical photos of the left eye in the same case, which involved a 53-year-old patient with severe ocular graft-versus-host disease with a broad pseudomembrane in the conjunctiva, obvious meibomian gland dysfunction in the lower eyelid, and corneal epitheliopathy. (A), (B), and (C) were recorded using the conventional slit-lamp microscope. (D), (E), and (F) were video recorded using the Smart Eye Camera. A and D show superior tarsal plate with a broad pseudomembrane in the conjunctiva with the diffuse illumination method. B and E show the lower conjunctiva and eyelid with pseudomembranes and meibomian gland dysfunction with the diffuse illumination method. D and F show the corneal epithelial disorder, both with a score of five out of nine points each (upper 2, middle 1, and lower 2) by the blue light illumination method.
Figure 3.
Figure 3.
Consecutive corneal photographs taken by the Smart Eye Camera invented for the evaluation of dry eye disease (DED). The photographs have been obtained for a DED case with positive objective signs and a short tear film breakup time (TFBUT). (A) Just after opening the eye, the fluorescence enhanced tear spread into the whole cornea. (B) One second after opening the eye, the superior extension of the tear film can be observed (Gibbs–Marangoni effect). (C) Two seconds after opening the eye, tear film breakup was still not observed. (D) Three seconds after opening the eye, a dry spot of the tear film was observed in the left part of the cornea. (E) Four seconds after opening the eye, the dry spot was clearly observed in several parts of the cornea. (F) Five seconds after opening the eye, the area of the dry spot expanded, suggesting a line break in the breakup pattern.
Figure 4.
Figure 4.
Receiver operating characteristic (ROC) curve for the diagnostic performance of the Smart Eye Camera for dry eye disease. ROC curve is shown in black, with the value of area under the receiver operating characteristic curve (AUC) and 95% confidence interval.
Figure 5.
Figure 5.
Breakup patterns observed using the Smart Eye Camera invented for the evaluation of dry eye disease. (A) Spot break. (B) Area break. (C) Dimple break. (D) Line break. (E) Random break.
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