Smart-TV Application for the Self Examination of the Distance Visual Acuity in Macular Edema Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Validation of a Smart-tv Application for the Self Examination of the Distance Visual Acuity in Macular Edema Patients

Conditions
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Low Vision, Macular Edema, Refractive Errors

Intervention / Treatment
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* Diagnostic Test: DDiVAT Testing
* Diagnostic Test: Distance visual acuity assessment via ETDRS chart


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age-dependent macular degeneration diabetic macular edema Exclusion Criteria: corneal diseases glaucoma psychiatric disorders inability to cooperate

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>100 patients with diagnosed macular edema will be enrolled | Diagnostic Test: DDiVAT Testing<br>* 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.<br>Diagnostic Test: Distance visual acuity assessment via ETDRS chart<br>* The distance visual acuity of each participant will be measured with the conventional method via ETDRS chart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance visual acuity test via ETDRS chart | The distance visual acuity of each participant will be evaluated by the same examiner | 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. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smart features, Smart-tv App