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

NCT04739137 — Unknown, 300 participants, Democritus University of Thrace

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

RegistryNCT04739137
StatusUnknown
Study typeObservational
Enrollment300 (Estimated)
SponsorDemocritus University of Thrace (Other)
ConditionsLow Vision, Macular Edema, Refractive Errors
InterventionsDDiVAT Testing, Distance visual acuity assessment via ETDRS chart (Diagnostic test)
Datesstart 2021-01-01, primary completion 2021-08-31 (estimated), completion 2021-09-30 (estimated), first posted 2021-02-04, last updated 2021-02-16
Locations1 site in Greece

Related Papers Related Patents Related Grants Related Experts
All trials for Low Vision All trials for Macular Edema All trials of DDiVAT Testing All trials of Distance visual acuity assessment via ETDRS chart

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Study groupDiagnostic Test: DDiVAT Testing; Diagnostic Test: Distance visual acuity assessment via ETDRS chart100 patients with diagnosed macular edema will be enrolled
  • 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.
  • 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

+Outcome measures

Primary outcomes

  • 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

Sex: All, ages: 40 Years to 85 Years, accepts healthy volunteers

Inclusion Criteria:

* age-dependent macular degeneration
* diabetic macular edema

Exclusion Criteria:

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

+Locations (1)

FacilityCityCountryStatus
Democritus University of ThraceAlexandroupoli, EvrosGreece

+Investigators