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Clinical Trials/NCT04756596
NCT04756596
Unknown
Not Applicable

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

Democritus University of Thrace2 sites in 1 country300 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Refractive Errors
Sponsor
Democritus University of Thrace
Enrollment
300
Locations
2
Primary Endpoint
Distance visual acuity using DDVIT vision test
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
June 30, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Democritus University of Thrace

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

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.

Study Sites (2)

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