Impact of ODYSight in the Management of patientS With imparairEd Visual acuitY

NCT06076785 | Unknown

• 1 other identifier: TIL-003
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 8

Brief Summary

Previous investigations have demonstrated the agreement between OdySight® and standardised methods in the evaluation of near visual acuity. The app allows for remote monitoring of this parameter with tracking changes. In case of decrease in visual acuity, a notification is sent to both patient and ophthalmologist. The aim of this study is to evaluate the medical relevance of OdySight® features in the management of patients suffering from impaired visual acuity.

Conditions

Impaired Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Impact of OdySight® in the management of patients suffering from impaired visual acuity.

  Number of patients concerned by one or more OdySight® notification(s) for visual acuity decrease followed by a visit where at least one of the following situations is noticed: * Visual acuity decrease * Anatomic ophthalmic deterioration * Prescription impact * Second eye newly affected and/or development of the pathology to the second eye

  At least 3 months of follow-up.

Secondary Outcomes (1)

• Performances of OdySight® in tracking visual acuity decrease and/or anatomic change.

  At least 3 months of follow-up.

Study Arms (1)

OdySight users

OdySight users between 07/21/2021 and 11/14/2022 who performed Visual Acuity testing through OdySight and according to standard practice.

Device: OdySight

Interventions

OdySight DEVICE

At home measurements of visual acuity through a mobile app.

OdySight users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a near visual acuity between 0.0 and 1.0 logMAR in at least one eye, and binocular VA equal to or better than 0.5 logMAR are targeted for this study.

You may qualify if:

• OdySight® user (between 07/21/2021 and 11/14/2022),
• Performed at least 3 tests on the same eye (minimum number of tests to trigger an alert).

You may not qualify if:

• Opposition to personal data collection and processing,
• Patient's death is documented.

Sponsors & Collaborators

• Tilak Healthcare: lead

Study Sites (8)

Centre Ophtalmologique Oculus

Chambéry, Auvergne-Rhône-Alpes, 73000, France

Location

Centre Ophtalmologique Rabelais

Lyon, Auvergne-Rhône-Alpes, 69002, France

Location

SELARL Dr Boulet

Évreux, Normandy, 27000, France

Location

Clinique Mathilde

Rouen, Normandy, 76000, France

Location

Clinique Honoré Cave

Montauban, Occitanie, 82000, France

Location

Institut Ophtalmologique de l'Ouest Jules Verne

Nantes, Pays de la Loire Region, 44300, France

Location

Institut ophtalmologique Sourdille Atlantique

Saint-Herblain, Pays de la Loire Region, 44800, France

Location

Hôpital des XV-XX

Paris, Île-de-France Region, 75012, France

Location

Related Publications (12)

• GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1.

  PMID: 33275949 BACKGROUND

• Claessens JLJ, Geuvers JR, Imhof SM, Wisse RPL. Digital Tools for the Self-Assessment of Visual Acuity: A Systematic Review. Ophthalmol Ther. 2021 Dec;10(4):715-730. doi: 10.1007/s40123-021-00360-3. Epub 2021 Jun 25.

  PMID: 34169468 BACKGROUND

• Srinivasan K, Ramesh SV, Babu N, Sanker N, Ray A, Karuna SM. Efficacy of a remote based computerised visual acuity measurement. Br J Ophthalmol. 2012 Jul;96(7):987-90. doi: 10.1136/bjophthalmol-2012-301751. Epub 2012 Apr 26.

  PMID: 22539747 BACKGROUND

• Yeung WK, Dawes P, Pye A, Neil M, Aslam T, Dickinson C, Leroi I. eHealth tools for the self-testing of visual acuity: a scoping review. NPJ Digit Med. 2019 Aug 22;2:82. doi: 10.1038/s41746-019-0154-5. eCollection 2019.

  PMID: 31453377 BACKGROUND

• Williams AM, Kalra G, Commiskey PW, Bowers EMR, Rudolph BR, Pitcher MD, Dansingani KK, Jhanji V, Nischal KK, Sahel JA, Waxman EL, Fu R. Ophthalmology Practice During the Coronavirus Disease 2019 Pandemic: The University of Pittsburgh Experience in Promoting Clinic Safety and Embracing Video Visits. Ophthalmol Ther. 2020 Sep;9(3):1-9. doi: 10.1007/s40123-020-00255-9. Epub 2020 May 6.

  PMID: 32377502 BACKGROUND

• Tiraset N, Poonyathalang A, Padungkiatsagul T, Deeyai M, Vichitkunakorn P, Vanikieti K. Comparison of Visual Acuity Measurement Using Three Methods: Standard ETDRS Chart, Near Chart and a Smartphone-Based Eye Chart Application. Clin Ophthalmol. 2021 Feb 26;15:859-869. doi: 10.2147/OPTH.S304272. eCollection 2021.

  PMID: 33664563 BACKGROUND

• Miller JM, Jang HS, Ramesh D, Gonzalez Marshall MS, Yescas S, Harvey EM. Telemedicine distance and near visual acuity tests for adults and children. J AAPOS. 2020 Aug;24(4):235-236. doi: 10.1016/j.jaapos.2020.06.003. Epub 2020 Jul 30.

  PMID: 32739362 BACKGROUND

• Iskander M, Hu G, Sood S, Heilenbach N, Sanchez V, Ogunsola T, Chen D, Elgin C, Patel V, Wronka A, Al-Aswad LA. Validation of the New York University Langone Eye Test Application, a Smartphone-Based Visual Acuity Test. Ophthalmol Sci. 2022 Jun 15;2(3):100182. doi: 10.1016/j.xops.2022.100182. eCollection 2022 Sep.

  PMID: 36245756 BACKGROUND

• Kielwasser G, Kodjikian L, Dot C, Burillon C, Denis P, Mathis T. Real-Life Value of the Odysight(R) Application in At-Home Screening for Exudative Recurrence of Macular Edema. J Clin Med. 2022 Aug 26;11(17):5010. doi: 10.3390/jcm11175010.

  PMID: 36078941 BACKGROUND

• Guigou S, Michel T, Merite PY, Coupier L, Meyer F. Home vision monitoring in patients with maculopathy: Real-life study of the OdySight application. J Fr Ophtalmol. 2021 Jun;44(6):873-881. doi: 10.1016/j.jfo.2020.09.034. Epub 2021 May 20.

  PMID: 34024655 BACKGROUND

• Brucker J, Bhatia V, Sahel JA, Girmens JF, Mohand-Said S. Odysight: A Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison with Standard Clinical Eye Tests. Ophthalmol Ther. 2019 Sep;8(3):461-476. doi: 10.1007/s40123-019-0203-9. Epub 2019 Jul 25.

  PMID: 31346977 BACKGROUND

• Allen L, Thirunavukarasu AJ, Podgorski S, Mullinger D. Novel web application for self-assessment of distance visual acuity to support remote consultation: a real-world validation study in children. BMJ Open Ophthalmol. 2021 Sep 30;6(1):e000801. doi: 10.1136/bmjophth-2021-000801. eCollection 2021.

  PMID: 34651083 BACKGROUND

Study Officials

• Bénédicte BROUSSEAU, MD

  Centre Ophtalmologique Ophtalliance

  PRINCIPAL INVESTIGATOR

• Maddalena QUARANTA, MD

  Centre Ophtalmologique Rabelais

  PRINCIPAL INVESTIGATOR

• Vincent GUALINO, MD

  Clinique Honoré Cave

  PRINCIPAL INVESTIGATOR

• Jean-François GIRMENS, MD

  Hopital des XV-XX

  PRINCIPAL INVESTIGATOR

• Isabelle FOURNIER, MD

  Institut ophtalmologique Sourdille Atlantique

  PRINCIPAL INVESTIGATOR

• Marie-Noëlle GUILLEMOT, MD

  Institut ophtalmologique Sourdille Atlantique

  PRINCIPAL INVESTIGATOR

• Jean-François BOULET, MD

  Cabinet d'ophtalmologie

  PRINCIPAL INVESTIGATOR

• Pierre-Olivier LAFONTAINE, MD

  Centre Ophtalmologique Oculus

  PRINCIPAL INVESTIGATOR

• Joël UZZAN, MD

  Clinique Mathilde

  PRINCIPAL INVESTIGATOR

• Viviane VINH, MD

  Centre d'Ophtalmologie du Dauphiné

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start: January 27, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)