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

Tilak Healthcare

Status: Completed

Conditions: Visual Impairment

Treatments: Other: Software as medical device

Study type: Observational

Funder types: Industry

Identifiers

NCT05510479

2020-A03583-36

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

58 participants in 1 patient group

OdySight vs Standardized methods

Description:

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

Treatment:

Other: Software as medical device