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
This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's enrollment of 120 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Tilak Healthcare is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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)
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)
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)
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)
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)
Plan to share: No
Ran from Mar 2018 to primary completion in Jul 2018, 4 months.
Of 234 industry-sponsored interventional studies with no phase under Myopia, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 24. This study's 4 months is below that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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