Croatian Version of the Ocular Surface Disease Index Questionnaire (OSDI) (Cro-OSDI)

Psychometric Properties of the Croatian Version of the Ocular Surface Disease Index Questionnaire

Ocular Surface Disease Index (OSDI) Questionnaire is an important tool for the diagnosis of dry eye disease. Croatian version is yet not available. With a permission of AbbVie company investigators want to make a Croatian version of the Ocular Surface Disease Index Questionnaire (Cro-OSDI).

Study Overview

• Status: Active, not recruiting
• Conditions: Dry Eye; Ocular Surface Disease
• Intervention / Treatment: Diagnostic test: Questionnaires and dry eye tests

Detailed Description

Aim is to translate, adapt and validate the Croatian version of the Ocular Surface Disease Index (OSDI) Questionnaire. Validation process of the Croatian version of the OSDI questionnaire will be accomplished in two phases: the translation and assessment of psychometric properties.

The translation process will involve the following steps based on the previously established guidelines. First is forward translation, the second is backward translation and the third is pilot study. The final version (the Cro-OSDI) will be used to test psychometric properties of the Croatian version of the questionnaire.

Eligible participants will complete the Cro-OSDI and and the previously validated Croatian version of the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25). After completing the respective questionnaires, the participants will undergo a complete ophthalmic examination for both eyes and dry eye tests (corneal fluorescein staining, lissamine green staining, Schirmer test type I and II, tear break-up time (TBUT), noninvasive tear breakup time (NIBUT)).

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • University Hospital Sestre Milosrdnice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients that are coming for an examination to an ophthalmology department of University Hospital.

Description

Inclusion Criteria:

• native Croatian-speaking participants with normal cognitive ability
• DED diagnosis complied with those defined by the DEWS II
• DED for at least 3 months
• BCVA logMAR< 0.6 or better

Exclusion Criteria:

• symptoms of conjunctivitis
• a history of contact lens use
• previous intraocular or ocular surface surgeries within the previous 6 months
• allergies
• eyelid malpositions
• ptosis
• Parkinson disease
• hereditary corneal disease
• any other disease that could affect blinking

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
with dry eye disease (DED); DED diagnosis defined by the Dry Eye Workshop (DEWS) II.	Diagnostic test: Questionnaires and dry eye tests; Ocular Surface Disease Index (OSDI), National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25), best visual acuity (BCVA) measuring, intraocular pressure, corneal fluorescein staining, lissamine green staining, Schirmer test type I and II, tear breakup time (TBUT) and noninvasive tear breakup time (NIBUT).
control (non-DED); No significant ocular disease other than refractive error and no systemic disease likely to be associated with dry eye. The non-DED group will be sex-matched and age-matched to the DED patients.	Diagnostic test: Questionnaires and dry eye tests; Ocular Surface Disease Index (OSDI), National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25), best visual acuity (BCVA) measuring, intraocular pressure, corneal fluorescein staining, lissamine green staining, Schirmer test type I and II, tear breakup time (TBUT) and noninvasive tear breakup time (NIBUT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI translation to the Croatian language and Cro-OSDI score measurement	Ocular Surface Disease Index will be first translated into Croatian language in forward and backward manner. Further on, translated (Cro-OSDI) will be conducted on population of selected participants, and the Cro-OSDI score will be determined. OSDI score is in a range from normal (0-12 points) till severe dry eye (33-100 points).	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cro-OSDI score comparison with the NEI VFQ-25 score	Cro-OSDI score that was measured as a Primary measure will then be compared with the translated and standardized score NEI VFQ-25 score, which will serve as a validation test for the translated Cro-OSDI score. In National Eye Institute Visual Functioning Questionnaire, 100 is the best score and 0 is the worst score.	2 months
Cro-OSDI score comparison with the Oxford scale, SICCA scale, scaled filter paper strips.	Cro-OSDI score that was measured as a Primary measure will then be compared with the dry eye clinical tests (corneal fluorescein staining scale from absent (0) to severe(5), lissamine green staining scale from 0-3 scale based on scale density, Schirmer test type I (under 5 mm is dry eye) and II (under 10 mm is dry eye), tear breakup time (TBUT, under 7 seconds is dry eye) and noninvasive tear breakup time (NIBUT-under 8 seconds is dry eye). This will serve as a validation procedure for the translated Cro-OSDI score.	2 months

Collaborators and Investigators

• Sponsor: University Hospital "Sestre Milosrdnice"
• Collaborators: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): November 2, 2023

Study Registration Dates

• First Submitted: June 10, 2023
• First Submitted That Met QC Criteria: July 9, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 251-29-11-23-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No