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

Completed

• Conditions: Visual Impairment
• Interventions: Other: Software as medical device

• Registration Number: NCT05510479
• Lead Sponsor: Tilak Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-05
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Study First Submitted: 2022-07-19
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-19
• Last Update Submitted: 2022-08-19
• Study First Posted: 2022-08-22
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OdySight vs Standardized methods	Software as medical device	All patients perform Visual Acuity testing through OdySight and according to standard practice

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Centre Ophtalmologique Rabelais; 🇫🇷 Lyon, France

Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts; 🇫🇷 Paris, Ile-de-France, France

Institut Ophtalmologique de l'Ouest Clinique Jules Verne; 🇫🇷 Nantes, France