Clinical trial NCT05510479: Post-market Evaluation of OdySight App to Monitor Near Visual Acuity at Home (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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Impairment
Keywords: Visual acuity
Digital therapeutics
Medical software
ETDRS
Macular Edema
Age-related Macular Degeneration
Lead sponsor: Tilak Healthcare
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a near visual acuity between 0.0 and 1.0 logMAR in at least one eye, and binocular VA equal to or better than 0.5 logMAR are targeted for this study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Equivalence between OdySight and standardized methods - Near Visual Acuity
timeFrame: 2 months
Secondary outcomes:
measure: Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity
timeFrame: 2 months
Other outcomes:
measure: Near Visual Acuity - Subgroups analysis
timeFrame: 2 months
measure: Near Visual Acuity variability
timeFrame: 2 months
measure: Vision changes tracking
timeFrame: 2 months
measure: Compliance to OdySight
timeFrame: 2 months
Locations:
city: Paris
country: France
facility: Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts
state: Ile-de-France
city: Lyon
country: France
facility: Centre Ophtalmologique Rabelais
city: Nantes
country: France
facility: Institut Ophtalmologique de l'Ouest Clinique Jules Verne
Study officials:
References: