A Web-based Digital Distance Visual Acuity Test (DDVIT)

November 13, 2021 updated by: Georgios Labiris, Democritus University of Thrace

Development and Validation of a Web-based Digital Distance Visual Acuity Test

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Present study aims to develop and validate a web-based digital distance visual acuity test (Democritus Distance Vision Test - DDVIT). DDVIT is an application, which will be easily accessed through a simple internet connection. This application will provide the possibility of a simple but reliable examination of patients, establishing a commonly accepted way of measuring the distance visual acuity among rural doctors, general practitioners and ophthalmologists.

Specifically, present study aims to develop a new online distance visual acuity test (DDVIT) according to the standards of the Early Treatment Diabetic Retinopathy Study (ETDRS) test and to evaluate the level of agreement between the two visual acuity tests, as well as the test-retest reliability of the online DDVIT visual acuity test.

The first part of the study is the development of the online visual acuity test (letters, numbers, symbols) including the following smart features:

  1. Adjustment of the font size according to the size of the computer screen used for the examination
  2. Real time calculation of the patient-screen distance through a face detection system
  3. Automatic calculation of the reading time of each line (each logMAR)
  4. Entering the number of patient's reading errors for each line

  5. Automatic calculation of the visual acuity in the following score units:

    • Number of Letters (max 85)
    • Visual Acuity Score (max 100)
    • logMAR
    • Decimal
    • Snellen Fraction

The calculation of various reading parameters resulting from the aforementioned features (visual acuity score in different units, reading duration (in sec) and number of errors for each slide (line), patient-screen distance for each slide) will be performed after the end of the examination. Except for the html format, a file in the format of Microsoft Excel and Pdf are also generated.

The second part of this study is the clinical validation of the DDVIT visual acuity test. In this part, the reading acuity measured with the DDVIT and ETDRS test are compared.

All the comparisons will take place in two groups: a) a Normal Vision Group (NVG), and b) a Low Vision Group (LVG) in order to estimate the visual acuity in a population with a wide range of vision.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Evros
      • Alexandroupolis, Evros, Greece, 68100
        • Recruiting
        • Department of Ophthalmology, University Hospital of Alexandroupolis
    • Thessaly
      • Lamía, Thessaly, Greece, 35100
        • Not yet recruiting
        • Department of Computer Science and Biomedical Informatics, University of Thessaly
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Diagnostic test: ETDRS testing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance visual acuity using DDVIT vision test
Time Frame: 4 months
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
Time Frame: 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Democritus University of Thrace

Collaborators

University of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 13, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES1/Th6/21-1-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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