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NCT Number: NCT07240480

Assessing the Turkish DDIVAT for Visual Acuity Measurement

The goal of this observational methodological study is to validate the Turkish version of the DDIVAT visual acuity measuring device in a Turkish-speaking adult population.

The main questions it aims to answer are:

Does the Turkish version of the DDIVAT provide reliable and valid visual acuity measurements in Turkish speakers?

Are the results of the DDIVAT comparable to those obtained with the standard Snellen chart used in clinical practice?

Researchers will compare DDIVAT visual acuity test results with Snellen chart results to see if both methods produce consistent measurements.

Participants will:

Be adults aged 18 years or older, including both patients and healthy volunteers.

Undergo visual acuity testing using the DDIVAT system displayed on a smart TV connected to the university server.

Have their visual acuity re-measured using the standard Snellen optotype under the same conditions.

No medication or invasive procedure will be used. The study carries no risk to participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study is a non-interventional, observational methodological validation study designed to evaluate the validity and reliability of the Turkish version of the DDIVAT (Digital Distance Interactive Visual Acuity Test) in a Turkish-speaking population.

The DDIVAT visual acuity test was originally developed and validated at Democritus University of Thrace (Greece) and has been approved by the National Medicines Organization as a Class I medical device. The current study aims to determine whether the Turkish-translated version of this visual acuity measurement tool performs consistently and accurately among Turkish-speaking participants.

Visual acuity is one of the most fundamental components of a comprehensive ophthalmological examination. It measures the clarity or sharpness of vision, which can be influenced by refractive errors and a variety of ocular diseases. Accurate and accessible tools for measuring visual acuity are therefore essential in both clinical and research settings.

In this study, 200 adult participants (aged 18 years and older) will be recruited from Trakya University Hospital, Department of Ophthalmology (Edirne, Türkiye). The study population will include both healthy volunteers and patients presenting to the ophthalmology clinic.

Each participant will undergo two visual acuity measurements under standardized conditions:

DDIVAT visual acuity test (Turkish version), administered via a smart TV connected to the university's secure server.

Snellen chart test, which represents the standard clinical practice currently used at Trakya University Hospital.

Measurements will be taken monocularly (each eye tested separately) while participants wear their current optical correction (e.g., eyeglasses or contact lenses).

The study will compare the two measurement methods to determine:

The level of agreement between DDIVAT and Snellen test results.

The test-retest reliability of the Turkish DDIVAT.

Since no medication, invasive procedure, or experimental intervention will be applied, the study poses no potential risk to participants. All procedures will comply with the Declaration of Helsinki, Good Clinical Practice (GCP) principles, and relevant data protection regulations.

Collected data will be stored anonymously and used solely for research purposes. The findings are expected to provide evidence supporting the use of DDIVAT as a reliable digital visual acuity tool for Turkish-speaking populations, enhancing accessibility and standardization of visual testing in both clinical and teleophthalmology contexts.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older

Turkish-speaking individuals able to understand the study purpose

Willingness to participate and provide written informed consent

Participants with or without refractive errors (e.g., myopia, hyperopia, astigmatism)

Exclusion criteria

  • Age below 18 years

Individuals unable to complete visual acuity testing

Presence of severe ocular pathology (e.g., corneal opacity, retinal detachment) that prevents accurate measurement

Cognitive or communication difficulties preventing informed consent

Treatment and study plan

DDIVAT Visual Acuity Test (Turkish Version)

Diagnostic Test

Participants' visual acuity will be measured using the Turkish version of the DDIVAT digital visual acuity device and compared with Snellen chart results. No treatment or invasive procedure will be performed.

Primary outcomes

  1. Agreement between DDIVAT (Turkish version) and Snellen chart visual acuity measurements

    Time frame: During a single study visit (same day assessment)

    The primary outcome is to assess the level of agreement between visual acuity scores obtained using the Turkish version of the DDIVAT digital visual acuity device and those obtained using the standard Snellen chart. Statistical analysis will include correlation and Bland-Altman agreement methods to evaluate consistency and validity between the two testing methods.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet Kaan Şimşek, Md.

CONTACT

[email protected]

+90 534 323 3010

Tuğçe Bek, M.D.

CONTACT

[email protected]

+90 533 560 2583

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

Validation of the Turkish Version of the DDIVAT Visual Acuity Measuring Device in a Turkish-speaking Population

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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