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Clinical Trials/NCT04756596
NCT04756596UnknownNot Applicable

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

Democritus University of Thrace2 sites in 1 country300 target enrollmentStarted: February 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
2
Primary Endpoint
Distance visual acuity using DDVIT vision test

Study 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Democritus University of Thrace

Study Sites (2)

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