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NCT04739137 Clinical Trial

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

Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04739137
Other study ID # ES1/Th5/21-1-2021
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date September 30, 2021

Study information
Verified date February 2021
Source Democritus University of Thrace
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date September 30, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria: - age-dependent macular degeneration - diabetic macular edema Exclusion Criteria: - corneal diseases - glaucoma - psychiatric disorders - inability to cooperate

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• DDiVAT Testing
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 chart
The distance visual acuity of each participant will be measured with the conventional method via ETDRS chart

Locations
Country Name City State
Greece Democritus University of Thrace Alexandroupolis Evros

Sponsors (1)
Lead Sponsor Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distance visual acuity test via ETDRS chart The distance visual acuity of each participant will be evaluated by the same examiner 1 week
Primary 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
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