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A Web-based Digital Distance Visual Acuity Test

NCT ID: NCT04756596

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Refractive Errors Low Vision Vision Disorders

Keywords

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web application distance visual acuity smart features face detection text calibration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

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

DDVIT testing

Intervention Type 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.

ETDRS testing

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Thessaly

OTHER

Sponsor Role collaborator

Democritus University of Thrace

OTHER

Sponsor Role lead

Responsible Party

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Georgios Labiris

Professor (Associate) of Democritus University of Thrace

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios Labiris, MD, PhD

Role: STUDY_CHAIR

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

Locations

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Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Site Status RECRUITING

Department of Computer Science and Biomedical Informatics, University of Thessaly

Lamía, Thessaly, Greece

Site Status NOT_YET_RECRUITING

Countries

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Greece

Central Contacts

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Georgios Labiris, MD, PhD

Role: CONTACT

Phone: 00302551030405

Email: [email protected]

Eirini - Kanella Panagiotopoulou, MD

Role: CONTACT

Phone: 00306978730858

Email: [email protected]

Facility Contacts

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Georgios Labiris, MD, PhD

Role: primary

Konstantinos Delibasis, PhD

Role: primary

Other Identifiers

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ES1/Th6/21-1-2021

Identifier Type: -

Identifier Source: org_study_id