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

Sponsor

Tilak Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT05510479

Collaborator

(none)

Enrollment

Locations

12.2

Actual Duration (Months)

19.3

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Visual Impairment	Other: Software as medical device

Study Design

Study Type:

Observational

Actual Enrollment :

58 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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)

Actual Study Start Date :

May 5, 2021

Actual Primary Completion Date :

May 11, 2022

Actual Study Completion Date :

May 11, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Equivalence between OdySight and standardized methods - Near Visual Acuity [2 months]
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.

Secondary Outcome Measures

Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity [2 months]
ETDRS visual acuity at a 4-meter distance at clinic and near visual acuity evaluated with ODYSIGHT at home.

Other Outcome Measures

Near Visual Acuity - Subgroups analysis [2 months]
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
Near Visual Acuity variability [2 months]
To assess variability of measurements with a smartphone-based evaluation of NVA with Odysight at home vs at clinic
Vision changes tracking [2 months]
To evaluate ability of the VA application module to track vision change over time as compared to standardized methods.
Compliance to OdySight [2 months]
To evaluate compliance of daily use among time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

General inclusion criteria:

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

Ophthalmic inclusion criterion:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts	Paris	Ile-de-France	France	75012
2	Centre Ophtalmologique Rabelais	Lyon		France	69002
3	Institut Ophtalmologique de l'Ouest Clinique Jules Verne	Nantes		France	44000