Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical App in Comparison to a Standardized Method
NCT ID: NCT03457441
Last Updated: 2018-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2018-03-20
2018-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
Standards 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
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
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
Standards 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
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
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
Standards 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
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
Interventions
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Standards 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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant and breastfeeding women.
* Subject not considered by the investigator or designee to correctly use OdySight modules after the training session
18 Years
ALL
Yes
Sponsors
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Tilak Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Saddek Mohan-Saïd, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Locations
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Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts
Paris, Île-de-France Region, France
Countries
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References
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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.
Other Identifiers
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2017-A03250-53
Identifier Type: -
Identifier Source: org_study_id
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