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Completed

NCT Number: NCT05510479

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

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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Key information

Conditions

Visual Impairment Eye Diseases Macular Degeneration Macular Edema Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts, Paris, Île-de-France Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

General inclusion criteria:

  • Age ≥ 18 years, all genders
  • Affiliated to or beneficiary of the French health care system
  • Signed/written informed consent
  • Already user of Odysight on a compatible smartphone/tablet
  • Patients willing and able to comply with all study and follow-up procedure

Ophthalmic inclusion criterion:

  • 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:

  • Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
  • Any planned surgery likely to modify patient refraction during the study (cataract surgery for example)
  • Subject not considered by the investigator or designee to correctly use ODYSIGHT modules
  • Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality
  • Not French speaking patient
  • Epileptic users

Treatment and study plan

Software as medical device

Other

At home measurements of visual acuity through a mobile app

Primary outcomes

  1. Equivalence between OdySight and standardized methods - Near Visual Acuity

    Time frame: 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 outcomes

  1. Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity

    Time frame: 2 months

    ETDRS visual acuity at a 4-meter distance at clinic and near visual acuity evaluated with ODYSIGHT at home.

Other outcomes

  1. Near Visual Acuity - Subgroups analysis

    Time frame: 2 months

    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. Near Visual Acuity variability

    Time frame: 2 months

    To assess variability of measurements with a smartphone-based evaluation of NVA with Odysight at home vs at clinic

  3. Vision changes tracking

    Time frame: 2 months

    To evaluate ability of the VA application module to track vision change over time as compared to standardized methods.

  4. Compliance to OdySight

    Time frame: 2 months

    To evaluate compliance of daily use among time.

Sponsors and collaborators

Lead sponsor

Tilak Healthcare

Industry

Registry information

Official study 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)

Acronym: TIL002

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 22, 2022
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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