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

NCT05510479 | Completed

• 1 other identifier: 2020-A03583-36
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Visual Impairment

Keywords

Visual acuity; Digital therapeutics; Medical software; ETDRS; Macular Edema; Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity

  2 months

Other Outcomes (4)

• Near Visual Acuity - Subgroups analysis

  2 months

• Near Visual Acuity variability

  2 months

• Vision changes tracking

  2 months

Study Arms (1)

OdySight vs Standardized methods

All patients perform Visual Acuity testing through OdySight and according to standard practice

Other: Software as medical device

Interventions

Software as medical device OTHER

At home measurements of visual acuity through a mobile app

OdySight vs Standardized methods

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:

• Age ≥ 18 years, all genders
• Affiliated to or beneficiary of the French health care system
• Signed/written informed consent
• Already user of Odysight on a compatible smartphone/tablet
• Patients willing and able to comply with all study and follow-up procedure
• Baseline binocular visual acuity with habitual correction ≥ 20/63 (3/10) AND with at least an eye ≥ 20/200 (1/10).

You may not qualify if:

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

Sponsors & Collaborators

• Tilak Healthcare: lead

Study Sites (3)

Centre Ophtalmologique Rabelais

Lyon, 69002, France

Location

Institut Ophtalmologique de l'Ouest Clinique Jules Verne

Nantes, 44000, France

Location

Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts

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

Location

MeSH Terms

Conditions

Vision Disorders; Macular Edema; Macular Degeneration

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Study Design

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

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 22, 2022
• Study Start: May 5, 2021
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)