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

University Hospital "Sestre Milosrdnice"

Status: Active, not recruiting

Conditions: Dry Eye; Ocular Surface Disease

Treatments: Diagnostic Test: Questionnaires and dry eye tests

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05938985

251-29-11-23-03

Details and patient eligibility

About

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).

Full 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)).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

with dry eye disease (DED)

Description:

DED diagnosis defined by the Dry Eye Workshop (DEWS) II.

Treatment:

Diagnostic Test: Questionnaires and dry eye tests

control (non-DED)

Description:

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.

Treatment:

Diagnostic Test: Questionnaires and dry eye tests