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

Active, not recruiting

• Conditions: Dry Eye; Ocular Surface Disease
• Interventions: Diagnostic Test: Questionnaires and dry eye tests

• Registration Number: NCT05938985
• Lead Sponsor: University Hospital "Sestre Milosrdnice"

Brief Summary

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).

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 Timeline

• Study First Submitted: 2023-06-10
• Study Start: 2023-06-12
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-09
• Last Update Submitted: 2023-07-09
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Primary Completion: 2023-10-31
• Study Completion: 2023-11-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with dry eye disease (DED)	Questionnaires and dry eye tests	DED diagnosis defined by the Dry Eye Workshop (DEWS) II.
control (non-DED)	Questionnaires and dry eye tests	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.

Primary Outcome Measures

Name	Time	Method
OSDI translation to the Croatian language and Cro-OSDI score measurement	2 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Cro-OSDI score comparison with the NEI VFQ-25 score	2 months	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.
Cro-OSDI score comparison with the Oxford scale, SICCA scale, scaled filter paper strips.	2 months	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.

Trial Locations

Locations (1)

University Hospital Sestre milosrdnice; 🇭🇷 Zagreb, Croatia