Clinical trial NCT05938985: Croatian Version of the Ocular Surface Disease Index Questionnaire (OSDI)
Official title: Psychometric Properties of the Croatian Version of the Ocular Surface Disease Index Questionnaire
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dry Eye
Ocular Surface Disease
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2023-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that are coming for an examination to an ophthalmology department of University Hospital.

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)).

Eligibility criteria: 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

Primary outcomes:
measure: OSDI translation to the Croatian language and Cro-OSDI score measurement
timeFrame: 2 weeks
Secondary outcomes:
measure: Cro-OSDI score comparison with the NEI VFQ-25 score
timeFrame: 2 months
measure: Cro-OSDI score comparison with the Oxford scale, SICCA scale, scaled filter paper strips.
timeFrame: 2 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Sestre milosrdnice
Study officials:
References: