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

• Conditions: Low Vision; Macular Edema; Refractive Errors
• Interventions: Diagnostic Test: DDiVAT Testing; Diagnostic Test: Distance visual acuity assessment via ETDRS chart

• Registration Number: NCT04739137
• Lead Sponsor: Democritus University of Thrace

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.

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 Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• age-dependent macular degeneration
• diabetic macular edema

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Distance visual acuity assessment via ETDRS chart	100 patients with diagnosed macular edema will be enrolled
Study group	DDiVAT Testing	100 patients with diagnosed macular edema will be enrolled

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Democritus University of Thrace; 🇬🇷 Alexandroupolis, Evros, Greece