Near VisionTIL-001NCT03457441
Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical App in Comparison to a Standardized Method
A study testing Standards vision tests and OdySight medical application assessment in people with Near Vision, run by Tilak Healthcare at 1 site in France.
Trial summary
This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Near Vision
- What is being tested?
- Standards vision tests and OdySight medical application assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2018to 24 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts
Paris, Île-de-France Region, 75012
About this study
Official title: Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical Application 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.
- Conditions
- Near Vision
- Being tested
- Standards vision tests, OdySight medical application assessment
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standards vision testsOther
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 assessmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Near visual acuity +1.0 and +0.7 logMAR | Other | 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 Receives: Other: Standards vision tests; Device: OdySight medical application assessment |
| Near visual acuity +0.6 and +0.3 logMAR | Other | 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 Receives: Other: Standards vision tests; Device: OdySight medical application assessment |
| Near visual acuity +0.2 and +0.0 logMAR | Other | 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 Receives: Other: Standards vision tests; Device: OdySight medical application assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 1 day ( During evaluation visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start20 Mar 2018
- Primary completion24 Jul 2018
- Study completion24 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Near VisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilak Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Saddek Mohan-Saïd, MD, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457441
- Sponsor's protocol ID
- 2017-A03250-53
- Acronym
- TIL-001
- Status last verified
- Jul 2018
- First submitted
- 20 Feb 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Near Visual Acuity With ODYSIGHT, a Smartphone Based Medical Application in Comparison to a Standardized Method
- ClinicalTrials.gov ID
- NCT03457441
- Acronym / sponsor ID
- TIL-001 / 2017-A03250-53
- Conditions
- Near Vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tilak HealthcareIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the level of agreement between visual parameters tested using OdySight, a mobile application, and standards in office methods.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Near visual acuity +1.0 and +0.7 logMAR | Other | Other: Standards vision tests, Device: OdySight medical application assessmentSubjects 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 |
| Near visual acuity +0.6 and +0.3 logMAR | Other | Other: Standards vision tests, Device: OdySight medical application assessmentSubjects 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 |
| Near visual acuity +0.2 and +0.0 logMAR | Other | Other: Standards vision tests, Device: OdySight medical application assessmentSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standards vision testsSubjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application | Other | Near visual acuity +0.2 and +0.0 logMAR, Near visual acuity +0.6 and +0.3 logMAR, Near visual acuity +1.0 and +0.7 logMAR |
| OdySight medical application assessmentSubjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application | Device | Near visual acuity +0.2 and +0.0 logMAR, Near visual acuity +0.6 and +0.3 logMAR, Near visual acuity +1.0 and +0.7 logMAR |
Primary outcome
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).
1 secondary outcome
Near visual acuity assessment with OdySight versus with ETDRS chart
Time frame: 1 day ( During evaluation visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Derived from this study: PubMed 31346977Brucker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saddek Mohan-Saïd, MD principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standards vision tests and OdySight medical application assessment in people with Near Vision, run by Tilak Healthcare at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near visual acuity assessment with OdySight versus with near visual acuity chart (time frame: 1 day ( During evaluation visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03457441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018.