Post-market Evaluation of OdySight App to Monitor Near Visual Acuity at Home (TIL002) (TIL002)

Post-market Study for At-home Evaluation of Near Visual Acuity With OdySight, a Smartphone Based Medical Application in Comparison to a Standardized Method (TIL002)

OdySight is a mobile application allowing self-testing of visual parameters including near visual acuity and communication of the data to an online dashboard to patient's doctors. TIL-002 post-market clinical trial objective is to evaluate the near visual acuity at home, measured with OdySight application in comparison to the standardized methods. The clinical trial is intended to prove that OdySight can provide relevant data and participate in the remote monitoring of subject vision.

Study Overview

• Status: Completed
• Conditions: Visual Impairment
• Intervention / Treatment: Other: Software as medical device

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69002
    • Centre Ophtalmologique Rabelais
  • Nantes, France, 44000
    • Institut Ophtalmologique de l'Ouest Clinique Jules Verne
  • Ile-de-France
    • Paris, Ile-de-France, France, 75012
      • Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

General inclusion criteria:

1. Age ≥ 18 years, all genders
2. Affiliated to or beneficiary of the French health care system
3. Signed/written informed consent
4. Already user of Odysight on a compatible smartphone/tablet

5. Patients willing and able to comply with all study and follow-up procedure

   Ophthalmic inclusion criterion:

6. Baseline binocular visual acuity with habitual correction ≥ 20/63 (3/10) AND with at least an eye ≥ 20/200 (1/10).

Exclusion Criteria:

General exclusion criteria:

1. Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
2. Any planned surgery likely to modify patient refraction during the study (cataract surgery for example)
3. Subject not considered by the investigator or designee to correctly use ODYSIGHT modules
4. Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality
5. Not French speaking patient
6. Epileptic users

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OdySight vs Standardized methods; All patients perform Visual Acuity testing through OdySight and according to standard practice	Other: Software as medical device; At home measurements of visual acuity through a mobile app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Equivalence between OdySight and standardized methods - Near Visual Acuity	To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT at home and standardized methods (Sloan ETDRS near vision letter chart and Landolt C near vision chart) performed in clinic.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity	ETDRS visual acuity at a 4-meter distance at clinic and near visual acuity evaluated with ODYSIGHT at home.	2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Visual Acuity - Subgroups analysis	To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT at home and with standardized methods in specific subgroups defined by visual acuity and by pathology	2 months
Near Visual Acuity variability	To assess variability of measurements with a smartphone-based evaluation of NVA with Odysight at home vs at clinic	2 months
Vision changes tracking	To evaluate ability of the VA application module to track vision change over time as compared to standardized methods.	2 months
Compliance to OdySight	To evaluate compliance of daily use among time.	2 months

Collaborators and Investigators

• Sponsor: Tilak Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Visual acuity; Digital therapeutics; Medical software; ETDRS; Macular Edema; Age-related Macular Degeneration
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision, Low; Vision Disorders
• Other Study ID Numbers: 2020-A03583-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No