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

NCT ID: NCT04739137

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-09-30

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.

Conditions

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Low Vision Macular Edema Refractive Errors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

100 patients with diagnosed macular edema will be enrolled

DDiVAT Testing

Intervention Type DIAGNOSTIC_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 chart

Intervention Type DIAGNOSTIC_TEST

The distance visual acuity of each participant will be measured with the conventional method via ETDRS chart

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Distance visual acuity assessment via ETDRS chart

The distance visual acuity of each participant will be measured with the conventional method via ETDRS chart

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

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Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Labiris

Role: STUDY_CHAIR

Democritus University of Thrace

Locations

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Democritus University of Thrace

Alexandroupoli, Evros, Greece

Site Status

Countries

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Greece

Other Identifiers

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ES1/Th5/21-1-2021

Identifier Type: -

Identifier Source: org_study_id

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