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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-05

Study Completion Date

2022-05-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Visual Impairment

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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OdySight vs Standardized methods

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

Software as medical device

Intervention Type OTHER

At home measurements of visual acuity through a mobile app

Interventions

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Software as medical device

At home measurements of visual acuity through a mobile app

Intervention Type OTHER

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes