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

Dry Eye Clinical Trial

— Cro-OSDI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05938985
• Other study ID #: 251-29-11-23-03
• Status: Active, not recruiting
• Start date: June 12, 2023
• Est. completion date: November 2, 2023

Study information

• Verified date: July 2023
• Source: University Hospital "Sestre Milosrdnice"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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)).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: November 2, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Ocular Surface Disease

Intervention

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).

Locations

Country	Name	City	State
Croatia	University Hospital Sestre milosrdnice	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital "Sestre Milosrdnice"	AbbVie

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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