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CompletedNCT03457441TIL-001Updated Jul 27, 2018

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

An interventional study of Standards vision tests and OdySight medical application assessment in Near Vision, sponsored by Tilak Healthcare. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-27.

Sponsored by Tilak Healthcare · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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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Conditions studied

  • Near Vision

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Other
    Near visual acuity +1.0 and +0.7 logMAR

    Subjects with near visual acuity between +1.0 and +0.7 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application

    Other: Standards vision tests · Device: OdySight medical application assessment

  • Other
    Near visual acuity +0.6 and +0.3 logMAR

    Subjects with near visual acuity between +0.6 and +0.3 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application

    Other: Standards vision tests · Device: OdySight medical application assessment

  • Other
    Near visual acuity +0.2 and +0.0 logMAR

    Subjects with near visual acuity between +0.2 and +0.0 logMAR , when eligible and providing informed consent, assigned to evaluation with OdySight mobile medical application

    Other: Standards vision tests · Device: OdySight medical application assessment

Interventions

  • OtherStandards vision tests

    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

  • DeviceOdySight medical application assessment

    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

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What researchers measure

Primary outcomes

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

    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).

    Time frame: 1 day ( During evaluation visit)

Secondary outcomes

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

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

    Time frame: 1 day ( During evaluation visit)

Other outcomes

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

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

    Time frame: 1 day ( During evaluation visit)

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

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

    Time frame: 1 day ( During evaluation visit)

  3. Global functional disorders assessment with Odysight versus with OCT

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

    Time frame: 1 day ( During evaluation visit)

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Study locations

1 site
  • Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts
    Paris, Ile-de-France 75012, France
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References and documents

Publications

  • Brucker J, Bhatia V, Sahel JA, Girmens JF, Mohand-Said S. Odysight: A Mobile Medical Application Designed for Remote Monitoring-A Prospective Study Comparison with Standard Clinical Eye Tests. Ophthalmol Ther. 2019 Sep;8(3):461-476. doi: 10.1007/s40123-019-0203-9. Epub 2019 Jul 25. PubMed 31346977 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03457441
Lead sponsor
Tilak Healthcare
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Mar 20, 2018
Primary completion
Jul 24, 2018
Completion
Jul 24, 2018
Last update
Jul 27, 2018

Study contacts

Saddek Mohan-Saïd, MD
principal investigator · Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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