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

February 12, 2021 updated by: Georgios Labiris, Democritus University of Thrace

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Democritus University of Thrace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Normal- and low-sighted participants aged 40 to 85 years

Description

Inclusion Criteria:

  • age-dependent macular degeneration
  • diabetic macular edema

Exclusion Criteria:

  • corneal diseases
  • glaucoma
  • psychiatric disorders
  • inability to cooperate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
100 patients with diagnosed macular edema will be enrolled
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Investigators

  • Study Chair: Georgios Labiris, Democritus University of Thrace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES1/Th5/21-1-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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