A Web-based Digital Distance Visual Acuity Test

NCT04756596 | Unknown

• 1 other identifier: ES1/Th6/21-1-2021
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Primary objective of this study is the development and validation of a web-based application for the examination of the distance visual acuity of normal- and low-vision patients.

Conditions

Refractive Errors; Low Vision; Vision Disorders

Keywords

web application; distance visual acuity; smart features; face detection; text calibration

Outcome Measures

Primary Outcomes (2)

• Distance visual acuity using DDVIT vision test

  The distance visual acuity of the one randomly selected eye of each participant will be evaluated by the examiner using DDVIT vision test.

  4 months

• Distance visual acuity using ETDRS vision test

  The distance visual acuity of the same eye of each participant will be evaluated by the same examiner using the web-based ETDRS vision test under the same predetermined environmental lighting conditions.

  4 months

Study Arms (1)

Study group

70 patients with normal vision (NVG) 30 patients with low vision (LVG) These patients will be tested on the DDVIT

Diagnostic Test: DDVIT testing; Diagnostic Test: ETDRS testing

Interventions

DDVIT testing DIAGNOSTIC_TEST

One randomly selected eye will be included for each study participant. Participants respond to the DDVIT test in standard environmental lighting conditions at 4 m viewing distance. Visual acuity will be evaluated.

Study group

ETDRS testing DIAGNOSTIC_TEST

The same eye is included for each study participant. Participants respond to the standard ETDRS chart of our Ophthalmology Department in standard environmental lighting conditions at 4 m viewing distance. Visual acuity will be evaluated.

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Normal- and low-sighted participants aged 18 to 75 years.

You may qualify if:

• Patients of our outpatient ophthalmology clinic
• Age between 18 to 75 years

You may not qualify if:

• Dyslexia
• Attention-deficiency
• Former diagnosis of mental and/or psychiatric diseases
• Inability to cooperate

Sponsors & Collaborators

• Democritus University of Thrace: lead
• University of Thessaly: collaborator

Study Sites (2)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

RECRUITING

Department of Computer Science and Biomedical Informatics, University of Thessaly

Lamía, Thessaly, 35100, Greece

NOT YET RECRUITING

MeSH Terms

Conditions

Refractive Errors; Vision, Low; Vision Disorders

Condition Hierarchy (Ancestors)

Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Georgios Labiris, MD, PhD

  Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

  STUDY CHAIR

Central Study Contacts

Georgios Labiris, MD, PhD

CONTACT

00302551030405; labiris@usa.net

Eirini - Kanella Panagiotopoulou, MD

CONTACT

00306978730858; eipanagi@med.duth.gr

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 12, 2021
• First Posted: February 16, 2021
• Study Start: February 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

GR (2)