TY - JOUR
T1 - Smart eye camera
T2 - A validation study for evaluating the tear film breakup time in human subjects
AU - Shimizu, Eisuke
AU - Yazu, Hiroyuki
AU - Aketa, Naohiko
AU - Yokoiwa, Ryota
AU - Sato, Shinri
AU - Katayama, Taiichiro
AU - Hanyuda, Akiko
AU - Sato, Yasunori
AU - Ogawa, Yoko
AU - Tsubota, Kazuo
N1 - Funding Information:
This is one of the Cross-ministerial strategic innovation promotion projects “AI hospital” at Keio University Hospital (Tokyo, Japan), supported by the Cabinet Office, Government of Japan. The authors thank Masahiro Jinzaki and Shigeru Ko, who are in charge of the AI hospital at Keio University Hospital, for providing helpful advice. All data associated with this study can be found in the server of the Department of Ophthalmology, Keio University School of Medicine.
Funding Information:
This is one of the Cross-ministerial strategic innovation promotion projects ?AI hospital? at Keio University Hospital (Tokyo, Japan), supported by the Cabinet Office, Government of Japan. The authors thank Masahiro Jinzaki and Shigeru Ko, who are in charge of the AI hospital at Keio University Hospital, for providing helpful advice. All data associated with this study can be found in the server of the Department of Ophthalmology, Keio University School of Medicine. Supported by the Japan Agency for Medical Research and Development (20he1022003h0001, 20hk0302008h0001, and 20hk0302008h0101), Uehara Memorial Foundation, Hitachi Global Foundation, Kondo Memorial Foundation, Eustylelab, and the Kowa Memorial Foundation. H.Y., E.S., and N.A. are the co-founders of OUI Inc. and own OUI Inc. stocks. OUI Inc. holds the patent for the Smart Eye Camera (Japanese Patent No. 6627071. Tokyo, Japan). There are no other relevant declarations relating to this patent. OUI Inc. did not have any additional role in the study design, data collection and analysis, decision to publish, preparation of the manuscript, or funding. The other authors declare no competing interests associated with this manuscript.
Funding Information:
Supported by the Japan Agency for Medical Research and Development (20he1022003h0001, 20hk0302008h0001, and 20hk0302008h0101), Uehara Memorial Foundation, Hitachi Global Foundation, Kondo Memorial Foundation, Eustylelab, and the Kowa Memorial Foundation.
Publisher Copyright:
© 2021 The Authors.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Corneal epithelium
KW - Dry eye disease (DED)
KW - Slit-lamp
KW - Smart eye camera (SEC)
KW - Tear film breakup time (TFBUT)
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UR - http://www.scopus.com/inward/citedby.url?scp=85100944584&partnerID=8YFLogxK
U2 - 10.1167/TVST.10.4.28
DO - 10.1167/TVST.10.4.28
M3 - Article
AN - SCOPUS:85100944584
SN - 2164-2591
VL - 10
JO - Translational Vision Science and Technology
JF - Translational Vision Science and Technology
IS - 4
M1 - 28
ER -