An observational study in Visual Impairment, sponsored by Tilak Healthcare. Completed at 3 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.
Sponsored by Tilak Healthcare · Observational
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.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's enrollment of 58 is below the median of 126 across 97 observational studies indexed under Vision Disorders.
Browse Vision Disorders 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.
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.
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.
General inclusion criteria:
Patients willing and able to comply with all study and follow-up procedure
Ophthalmic inclusion criterion:
Exclusion Criteria:
General 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.
All patients perform Visual Acuity testing through OdySight and according to standard practice
Other: Software as medical device
At home measurements of visual acuity through a mobile app
Equivalence between OdySight and standardized methods - Near Visual Acuity
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.
Time frame: 2 months
Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity
ETDRS visual acuity at a 4-meter distance at clinic and near visual acuity evaluated with ODYSIGHT at home.
Time frame: 2 months
Near Visual Acuity - Subgroups analysis
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
Time frame: 2 months
Near Visual Acuity variability
To assess variability of measurements with a smartphone-based evaluation of NVA with Odysight at home vs at clinic
Time frame: 2 months
Vision changes tracking
To evaluate ability of the VA application module to track vision change over time as compared to standardized methods.
Time frame: 2 months
Compliance to OdySight
To evaluate compliance of daily use among time.
Time frame: 2 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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