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

Visual Impairment Clinical Trial

— TIL002  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05510479
• Other study ID #: 2020-A03583-36
• Status: Completed
• Start date: May 5, 2021
• Est. completion date: May 11, 2022

Study information

• Verified date: August 2022
• Source: Tilak Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Other:
• Software as medical device
At home measurements of visual acuity through a mobile app

Locations

Country	Name	City	State
France	Centre Ophtalmologique Rabelais	Lyon
France	Institut Ophtalmologique de l'Ouest Clinique Jules Verne	Nantes
France	Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Tilak Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Vision changes tracking	To evaluate ability of the VA application module to track vision change over time as compared to standardized methods.	2 months
Other	Compliance to OdySight	To evaluate compliance of daily use among time.	2 months
Primary	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	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