Validation of DDIVAT Digital Optotypes for Distance Visual Acuity Testing Among the Bulgarian Population

NCT ID: NCT07208838

Last Updated: 2025-10-06

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

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-07-01

Brief Summary

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To compare distance visual acuity in Bulgarian patients over 18 years of age using two different methods - the Snellen method and the DIDIVAT digital online optotypes. For the purpose of this study, it is planned to examine native visual acuity (with and without prescribed optical correction), without additional mydriasis in both ways, of 150 Bulgarian patients (75 women and 75 men) over 18 years of age, hospitalized in a university eye clinic at St. George University Hospital and healthy volunteers willing to participate in the study. The statistical analysis that will be performed will aim to compare whether the two methods for determining distance visual acuity are identical in results, as well as to validate the application for the Bulgarian population.The study is expected to prove that the distance visual acuity of patients examined by both methods is identical.

Detailed Description

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Conditions

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Vision Screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy participants

75 males and 75 females over 18 years of age

To test visual acuity in 150 Bulgarian patients over 18 years of age using Snellens visual acuity chart and DDIVAT optotypes

Intervention Type DIAGNOSTIC_TEST

The study compares newly developed visual acuity test (DDIVAT) with standart method for visual acuity testing used worldwide

Interventions

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To test visual acuity in 150 Bulgarian patients over 18 years of age using Snellens visual acuity chart and DDIVAT optotypes

The study compares newly developed visual acuity test (DDIVAT) with standart method for visual acuity testing used worldwide

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Bulgarian speaking patients (75 women and 75 men) over 18 years of age, hospitalized in a university eye clinic at St. George University Hospital and healthy volunteers willing to participate in the study.

Exclusion Criteria

* Patients of less than 18 years of age.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Democritus University of Thrace

OTHER

Sponsor Role collaborator

Plovdiv Medical University

OTHER

Sponsor Role lead

Responsible Party

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Vasil Marinov

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University Plovdiv

Plovdiv, , Bulgaria

Site Status

Countries

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Bulgaria

References

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Bakirtzis M, Michaleakou E, Martidou ME, Lahana E, Kostagiolas P, Niakas D, Labiris G. Visual Acuity Screening of Refugees and Immigrants with a Web-Based Digital Test: A Pilot Study. Acta Medica (Hradec Kralove). 2024;67(3):79-86. doi: 10.14712/18059694.2025.2.

Reference Type BACKGROUND
PMID: 39963735 (View on PubMed)

Labiris G, Panagiotopoulou EK, Duzha E, Tzinava M, Perente A, Konstantinidis A, Delibasis K. Development and Validation of a Web-Based Reading Test for Normal and Low Vision Patients. Clin Ophthalmol. 2021 Sep 22;15:3915-3929. doi: 10.2147/OPTH.S314943. eCollection 2021.

Reference Type BACKGROUND
PMID: 34588763 (View on PubMed)

Labiris G, Panagiotopoulou EK, Chatzimichael E, Tzinava M, Mataftsi A, Delibasis K. Introduction of a digital near-vision reading test for normal and low vision adults: development and validation. Eye Vis (Lond). 2020 Oct 22;7:51. doi: 10.1186/s40662-020-00216-0. eCollection 2020.

Reference Type BACKGROUND
PMID: 33102611 (View on PubMed)

Labiris G, Panagiotopoulou EK, Delibasis K, Duzha E, Bakirtzis M, Panagis C, Boboridis K, Mokka A, Balidis M, Damtsi C, Ntonti P. Validation of a web-based distance visual acuity test. J Cataract Refract Surg. 2023 Jul 1;49(7):666-671. doi: 10.1097/j.jcrs.0000000000001176.

Reference Type BACKGROUND
PMID: 36853857 (View on PubMed)

Other Identifiers

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PlovdivMUDDIVAT

Identifier Type: -

Identifier Source: org_study_id

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