Visual ImpairmentTIL002NCT05510479
Post-market Evaluation of OdySight App to Monitor Near Visual Acuity at Home (TIL002)
An observational study of Visual Impairment, run by Tilak Healthcare at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment
- What is being tested?
- Software as medical device
- How many people
- 58 participants
- Where
- 3 sitesFrance
- Study dates
- 5 May 2021to 11 May 2022
- Phase
- Observational
- 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
Study population: 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.
Who may be able to join
- General inclusion criteria:
- Age ≥ 18 years, all genders
- Affiliated to or beneficiary of the French health care system
- Signed/written informed consent
- Already user of Odysight on a compatible smartphone/tablet
- Patients willing and able to comply with all study and follow-up procedure
- Ophthalmic inclusion criterion:
- Baseline binocular visual acuity with habitual correction ≥ 20/63 (3/10) AND with at least an eye ≥ 20/200 (1/10).
Who cannot join
- General exclusion criteria:
- Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
- Any planned surgery likely to modify patient refraction during the study (cataract surgery for example)
- Subject not considered by the investigator or designee to correctly use ODYSIGHT modules
- Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality
- Not French speaking patient
- Epileptic users
Trial locations and contacts
3 sites in 1 country.
France3 sites
Centre Ophtalmologique Rabelais
Lyon, 69002
Institut Ophtalmologique de l'Ouest Clinique Jules Verne
Nantes, 44000
Centre Hospitalier National d'Ophtahlomogie du Quinze-Vingts
Paris, Île-de-France Region, 75012
About this study
Official title: Post-market Study for At-home Evaluation of Near Visual Acuity With OdySight, a Smartphone Based Medical Application in Comparison to a Standardized Method (TIL002)
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.
- Conditions
- Visual Impairment
- Being tested
- Software as medical device
- Keywords
- Visual acuity, Digital therapeutics, Medical software, ETDRS, Macular Edema, Age-related Macular Degeneration
- Medical subject headings
- Vision Disorders, Macular Edema, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software as medical deviceOther
At home measurements of visual acuity through a mobile app
| Study group | Role | What they receive |
|---|---|---|
| OdySight vs Standardized methods | All patients perform Visual Acuity testing through OdySight and according to standard practice Receives: Other: Software as medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (1)
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start5 May 2021
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilak Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510479
- Sponsor's protocol ID
- 2020-A03583-36
- Acronym
- TIL002
- Status last verified
- Aug 2022
- First submitted
- 19 Jul 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Study for At-home Evaluation of Near Visual Acuity With OdySight, a Smartphone Based Medical Application in Comparison to a Standardized Method (TIL002)
- ClinicalTrials.gov ID
- NCT05510479
- Acronym / sponsor ID
- TIL002 / 2020-A03583-36
- Conditions
- Visual Impairment
- Keywords
- Visual acuity, Digital therapeutics, Medical software, ETDRS, Macular Edema, Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Tilak HealthcareIndustry (pharma, biotech, devices)
- Study start
- 5 May 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 22 Aug 2022 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OdySight vs Standardized methods | – | Other: Software as medical deviceAll patients perform Visual Acuity testing through OdySight and according to standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Age ≥ 18 years, all genders
- Affiliated to or beneficiary of the French health care system
- Signed/written informed consent
- Already user of Odysight on a compatible smartphone/tablet
- Patients willing and able to comply with all study and follow-up procedure
Key exclusion criteria (7 listed)
- Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
- Any planned surgery likely to modify patient refraction during the study (cataract surgery for example)
- Subject not considered by the investigator or designee to correctly use ODYSIGHT modules
- Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality
- Not French speaking patient
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 |
|---|---|---|
| Software as medical deviceAt home measurements of visual acuity through a mobile app | Other | OdySight vs Standardized methods |
Primary outcome
Equivalence between OdySight and standardized methods - Near Visual Acuity
Time frame: 2 months
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.
1 secondary outcome
Equivalence between OdySight and standardized methods - 4-meter distance Visual Acuity
Time frame: 2 months
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 22 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Impairment, run by Tilak Healthcare at 3 sites 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 8 inclusion and 7 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 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Equivalence between OdySight and standardized methods - Near Visual Acuity (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2022.