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Completed

NCT Number: NCT03457441

Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical App in Comparison to a Standardized Method

This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.

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Key information

Conditions

Near Vision Eye Diseases Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts

Paris, Île-de-France Region, 75012, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥ 18 years
  • Able to correctly distinguish the body laterality (left and right)
  • Able to recognize alphabet letters and read French
  • Affiliated to or beneficiary of the French health care system
  • Signed/written informed consent
  • Subject presenting a level of visual acuity of one of his eyes that fits to one of the pre-set cohort (visual acuity between +1.0 and +0.7 logMAR, between +0.6 and +0.3 logMAR or between +0.2 and 0.0 logMAR); the two eyes can be included in two different cohorts.

Exclusion criteria

  • Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
  • Pregnant and breastfeeding women.
  • Subject not considered by the investigator or designee to correctly use OdySight modules after the training session

Treatment and study plan

Standards vision tests

Other

Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application

OdySight medical application assessment

Device

Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application

Primary outcomes

  1. Near visual acuity assessment with OdySight versus with near visual acuity chart

    Time frame: 1 day ( During evaluation visit)

    To assess the equivalence between a smartphone based evaluation of near visual acuity with ODYSIGHT (NVA module) and a standardized method (Sloan ETDRS near vision letter chart).

Secondary outcomes

  1. Near visual acuity assessment with OdySight versus with ETDRS chart

    Time frame: 1 day ( During evaluation visit)

    To assess the relation between the ETDRS visual acuity at a 4-meter distance and near visual acuity evaluated with ODYSIGHT (NVA module)

Other outcomes

  1. Contrast sensitivity assessment with OdySight versus with Pelli-Robson

    Time frame: 1 day ( During evaluation visit)

    To compare the smartphone based evaluation of the contrast sensitivity with ODYSIGHT (contrast sensitivity module) and a standardized method (Pelli-Robson chart)

  2. Scotoma/metamorphopsia detection with OdySight versus with standard Amsler grid

    Time frame: 1 day ( During evaluation visit)

    To compare the smartphone based evaluation of the Amsler Grid with ODYSIGHT (Amsler grid module) and standardized methods (paper Amsler Grid)

  3. Global functional disorders assessment with Odysight versus with OCT

    Time frame: 1 day ( During evaluation visit)

    To compare functional disorder(s) detected or measured by ODYSIGHT application with anatomical data (OCT: Optical coherence tomography)

Sponsors and collaborators

Lead sponsor

Tilak Healthcare

Industry

Registry information

Official study title

Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical Application in Comparison to a Standardized Method

Acronym: TIL-001

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2018
Registry last updated
Jul 27, 2018

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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