Low VisionNCT04739137
Smart-TV Application for the Self Examination of the Distance Visual Acuity in Macular Edema Patients
An observational study of Low Vision and Macular Edema, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of our study is the development and validation of an application for smart-TVs for the self-examination of the distant visual acuity of patients diagnosed with macular edema. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Vision, Macular Edema, Refractive Errors
- What is being tested?
- DDiVAT Testing and Distance visual acuity assessment via ETDRS chart
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2021to 30 Sep 2021
- How long will I take part?
- 15 Days
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal- and low-sighted participants aged 40 to 85 years
Who may be able to join
- age-dependent macular degeneration
- diabetic macular edema
Who cannot join
- corneal diseases
- glaucoma
- psychiatric disorders
- inability to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a Smart-tv Application for the Self Examination of the Distance Visual Acuity in Macular Edema Patients
Primary objective of our study is the development and validation of an application for smart-TVs for the self-examination of the distant visual acuity of patients diagnosed with macular edema.
Read the detailed description
Present study aims to develop and validate an application installed in Smart-TVs. This application will be referred to patients suffering from macular edema, allowing the self-examination of the patient in terms of distant visual acuity. The development of a simple but reliable way of self-examination of distant visual acuity would bring beneficial results in the overall management of these patients as significantly would reduce the flows to the outpatient ophthalmology clinics of the NSS Hospitals, would serve the purposes of the social distancing imposed by the current state of the pandemic but also any analogous situation and would help the patient to be vigilant and actively involved in the management of his disease.
- Conditions
- Low Vision, Macular Edema, Refractive Errors
- Being tested
- DDiVAT Testing, Distance visual acuity assessment via ETDRS chart
- Keywords
- smart features, Smart-tv App
- Medical subject headings
- Vision, Low, Macular Edema, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDiVAT TestingDiagnostic test
Participants will self examine his/her distance visual acuity via application in a simulation room of our department with certain predetermined environmental lighting conditions using the same smart devices.
Distance visual acuity assessment via ETDRS chartDiagnostic test
The distance visual acuity of each participant will be measured with the conventional method via ETDRS chart
| Study group | Role | What they receive |
|---|---|---|
| Study group | 100 patients with diagnosed macular edema will be enrolled Receives: Diagnostic Test: DDiVAT Testing; Diagnostic Test: Distance visual acuity assessment via ETDRS chart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance visual acuity test via ETDRS chart
The distance visual acuity of each participant will be evaluated by the same examiner
Measured: 1 week
Distance visual acuity self assessment via DDiVAT
Participants will self examine his/her distance visual acuity via application in a simulation room of our department with certain predetermined environmental lighting conditions using the same smart devices.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Jan 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, Study chair, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739137
- Sponsor's protocol ID
- ES1/Th5/21-1-2021
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Smart-tv Application for the Self Examination of the Distance Visual Acuity in Macular Edema Patients
- ClinicalTrials.gov ID
- NCT04739137
- Acronym / sponsor ID
- ES1/Th5/21-1-2021
- Conditions
- Low Vision, Macular Edema, Refractive Errors
- Keywords
- smart features, Smart-tv App
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 4 Feb 2021 (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.
Primary objective of our study is the development and validation of an application for smart-TVs for the self-examination of the distant visual acuity of patients diagnosed with macular edema.
Detailed description
Present study aims to develop and validate an application installed in Smart-TVs. This application will be referred to patients suffering from macular edema, allowing the self-examination of the patient in terms of distant visual acuity. The development of a simple but reliable way of self-examination of distant visual acuity would bring beneficial results in the overall management of these patients as significantly would reduce the flows to the outpatient ophthalmology clinics of the NSS Hospitals, would serve the purposes of the social distancing imposed by the current state of the pandemic but also any analogous situation and would help the patient to be vigilant and actively involved in the management of his disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: DDiVAT Testing, Diagnostic Test: Distance visual acuity assessment via ETDRS chart100 patients with diagnosed macular edema will be enrolled |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal- and low-sighted participants aged 40 to 85 years
Key inclusion criteria (2 listed)
- age-dependent macular degeneration
- diabetic macular edema
Key exclusion criteria (4 listed)
- corneal diseases
- glaucoma
- psychiatric disorders
- inability to cooperate
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 |
|---|---|---|
| DDiVAT TestingParticipants will self examine his/her distance visual acuity via application in a simulation room of our department with certain predetermined environmental lighting conditions using the same smart devices. | Diagnostic test | Study group |
| Distance visual acuity assessment via ETDRS chartThe distance visual acuity of each participant will be measured with the conventional method via ETDRS chart | Diagnostic test | Study group |
Primary outcome
Distance visual acuity test via ETDRS chart
Time frame: 1 week
The distance visual acuity of each participant will be evaluated by the same examiner
Distance visual acuity self assessment via DDiVAT
Time frame: 1 week
Participants will self examine his/her distance visual acuity via application in a simulation room of our department with certain predetermined environmental lighting conditions using the same smart devices.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Georgios Labiris study chair
Democritus University of Thrace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Vision and Macular Edema, run by Democritus University of Thrace at 1 site in Greece.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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 Greece. 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?
Results are not available in the source record.
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?
Distance visual acuity test via ETDRS chart (time frame: 1 week). The study lists 2 primary outcomes in all. 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 16 Feb 2021.