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

Sponsor

Democritus University of Thrace (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04739137

Collaborator

(none)

300

Enrollment

Location

8.9

Anticipated Duration (Months)

33.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Low Vision Macular Edema Refractive Errors	Diagnostic Test: DDiVAT Testing Diagnostic Test: Distance visual acuity assessment via ETDRS chart

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Distance visual acuity test via ETDRS chart [1 week]
The distance visual acuity of each participant will be evaluated by the same examiner
Distance visual acuity self assessment via DDiVAT [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age-dependent macular degeneration
diabetic macular edema

Exclusion Criteria:

corneal diseases
glaucoma
psychiatric disorders
inability to cooperate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Democritus University of Thrace	Alexandroupolis	Evros	Greece	68100

Sponsors and Collaborators

Democritus University of Thrace

Investigators

Study Chair: Georgios Labiris, Democritus University of Thrace

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace

ClinicalTrials.gov Identifier:

NCT04739137

Other Study ID Numbers:

ES1/Th5/21-1-2021

First Posted:

Feb 4, 2021

Last Update Posted:

Feb 16, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Georgios Labiris, Professor (Associate) of Democritus University of Thrace, Democritus University of Thrace

smart features

Smart-tv App

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2021