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

NCT04739137 | Unknown

• 1 other identifier: ES1/Th5/21-1-2021
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Vision; Macular Edema; Refractive Errors

Keywords

smart features; Smart-tv App

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Study group

100 patients with diagnosed macular edema will be enrolled

Diagnostic Test: DDiVAT Testing; Diagnostic Test: Distance visual acuity assessment via ETDRS chart

Interventions

DDiVAT Testing 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.

Study group

Distance visual acuity assessment via ETDRS chart DIAGNOSTIC_TEST

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

Study group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• age-dependent macular degeneration
• diabetic macular edema

You may not qualify if:

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

Sponsors & Collaborators

• Democritus University of Thrace: lead

Study Sites (1)

Democritus University of Thrace

Alexandroupoli, Evros, 68100, Greece

Location

MeSH Terms

Conditions

Vision, Low; Macular Edema; Refractive Errors

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Study Officials

• Georgios Labiris

  Democritus University of Thrace

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Associate) of Democritus University of Thrace

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: January 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 30, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

GR (1)