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Odysight: A Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison with Standard Clinical Eye Tests.
Ophthalmol Ther 2019; 8(3):461-476OT

Abstract

INTRODUCTION

The purpose of this study (Tilak Study No: TIL-001) was to evaluate the medical modules on the mobile medical application OdySight and compare them to the gold standard tests for visual acuity, contrast sensitivity, and Amsler Grid.

METHODS

A total of 120 eyes were evaluated in an open-label, single-arm, prospective, single-site study during which participants performed monocular, gold standard tests for measuring visual acuity (Sloan Early Treatment Diabetic Retinopathy Study [ETDRS] letter chart at 40 cm testing distance and ETDRS letter chart at 4 m testing distance [40-cm and 4-m ETDRS, respectively), contrast sensitivity (Pelli-Robson contrast sensitivity chart [Pelli-Robson test]), and metamorphopsia/scotoma (Amsler Grid) followed by the respective modules on OdySight (also monocular). During this study, both the distance between the device and the patient's eye and room illumination were controlled by the examiner.

RESULTS

A Bland-Altman analysis demonstrated that there was no disagreement between the results of the OdySight visual acuity module and both the 40-cm Sloan ETDRS and 4-m ETDRS tests, with a very low level of bias (0.53 and - 1.53 letters, respectively). The same analysis of contrast sensitivity showed a broader disagreement between the results of the OdySight module and those of the Pelli-Robson test. A McNemar test indicated that there was no significant difference between results obtained by the OdySight Amsler Grid module and those obtained by the paper version for the detection of metamorphopsia and scotoma (p = 1.0 for both).

CONCLUSION

The results from the TIL-001 study demonstrate good agreement, overall, between the measurements taken by the near visual acuity module and the Amsler grid module of OdySight as compared to currently used gold standards. The contrast sensitivity module of OdySight will require additional investigation. OdySight could be used for remote monitoring of vision between clinic visits and potentially assist in follow-up planning.

FUNDING

Tilak Healthcare funded the study and the Rapid Service Fees.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT03457441.

Authors+Show Affiliations

Tilak Healthcare, 74 Rue de Faubourg Saint Antoine, 75012, Paris, France.Tilak Healthcare, 74 Rue de Faubourg Saint Antoine, 75012, Paris, France. vbhatia@tilakhealthcare.com.University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Vision Institute (Institut de la Vision), Paris, France.Quinze-Vingts National Eye Hospital, Paris, France.Quinze-Vingts National Eye Hospital, Paris, France.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31346977

Citation

Brucker, Julie, et al. "Odysight: a Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison With Standard Clinical Eye Tests." Ophthalmology and Therapy, vol. 8, no. 3, 2019, pp. 461-476.
Brucker J, Bhatia V, Sahel JA, et al. Odysight: A Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison with Standard Clinical Eye Tests. Ophthalmol Ther. 2019;8(3):461-476.
Brucker, J., Bhatia, V., Sahel, J. A., Girmens, J. F., & Mohand-Saïd, S. (2019). Odysight: A Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison with Standard Clinical Eye Tests. Ophthalmology and Therapy, 8(3), pp. 461-476. doi:10.1007/s40123-019-0203-9.
Brucker J, et al. Odysight: a Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison With Standard Clinical Eye Tests. Ophthalmol Ther. 2019;8(3):461-476. PubMed PMID: 31346977.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Odysight: A Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison with Standard Clinical Eye Tests. AU - Brucker,Julie, AU - Bhatia,Vinona, AU - Sahel,José-Alain, AU - Girmens,Jean-François, AU - Mohand-Saïd,Saddek, Y1 - 2019/07/25/ PY - 2019/06/13/received PY - 2019/7/28/pubmed PY - 2019/7/28/medline PY - 2019/7/27/entrez KW - AMD KW - Amsler grid KW - App KW - ETDRS KW - Eye diseases KW - Mobile medical game KW - OdySight KW - Remote monitoring KW - Visual acuity KW - mHealth SP - 461 EP - 476 JF - Ophthalmology and therapy JO - Ophthalmol Ther VL - 8 IS - 3 N2 - INTRODUCTION: The purpose of this study (Tilak Study No: TIL-001) was to evaluate the medical modules on the mobile medical application OdySight and compare them to the gold standard tests for visual acuity, contrast sensitivity, and Amsler Grid. METHODS: A total of 120 eyes were evaluated in an open-label, single-arm, prospective, single-site study during which participants performed monocular, gold standard tests for measuring visual acuity (Sloan Early Treatment Diabetic Retinopathy Study [ETDRS] letter chart at 40 cm testing distance and ETDRS letter chart at 4 m testing distance [40-cm and 4-m ETDRS, respectively), contrast sensitivity (Pelli-Robson contrast sensitivity chart [Pelli-Robson test]), and metamorphopsia/scotoma (Amsler Grid) followed by the respective modules on OdySight (also monocular). During this study, both the distance between the device and the patient's eye and room illumination were controlled by the examiner. RESULTS: A Bland-Altman analysis demonstrated that there was no disagreement between the results of the OdySight visual acuity module and both the 40-cm Sloan ETDRS and 4-m ETDRS tests, with a very low level of bias (0.53 and - 1.53 letters, respectively). The same analysis of contrast sensitivity showed a broader disagreement between the results of the OdySight module and those of the Pelli-Robson test. A McNemar test indicated that there was no significant difference between results obtained by the OdySight Amsler Grid module and those obtained by the paper version for the detection of metamorphopsia and scotoma (p = 1.0 for both). CONCLUSION: The results from the TIL-001 study demonstrate good agreement, overall, between the measurements taken by the near visual acuity module and the Amsler grid module of OdySight as compared to currently used gold standards. The contrast sensitivity module of OdySight will require additional investigation. OdySight could be used for remote monitoring of vision between clinic visits and potentially assist in follow-up planning. FUNDING: Tilak Healthcare funded the study and the Rapid Service Fees. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03457441. SN - 2193-8245 UR - https://www.unboundmedicine.com/medline/citation/31346977/Odysight:_A_Mobile_Medical_Application_Designed_for_Remote_Monitoring-A_Prospective_Study_Comparison_with_Standard_Clinical_Eye_Tests L2 - https://dx.doi.org/10.1007/s40123-019-0203-9 DB - PRIME DP - Unbound Medicine ER -