NCT05938985

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University Hospital Sestre Milosrdnice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)).

Conditions

• Dry Eye
• Ocular Surface Disease

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2023-06-12
• Primary completion: 2023-10-31
• Completion: 2023-11-02
• First posted: 2023-07-11
• Last updated: 2023-07-11

Locations

1 site across 1 country: Croatia