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

Sponsor

University Hospital "Sestre Milosrdnice" (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05938985

Collaborator

AbbVie (Industry)

150

Enrollment

Location

4.7

Anticipated Duration (Months)

31.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Ocular Surface Disease	Diagnostic Test: Questionnaires and dry eye tests

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jun 12, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Nov 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
with dry eye disease (DED) DED diagnosis defined by the Dry Eye Workshop (DEWS) II.	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).
control (non-DED) 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.	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).

Arm

Intervention/Treatment

with dry eye disease (DED)

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

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).

control (non-DED)

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.

Diagnostic Test: Questionnaires and dry eye tests

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Sestre milosrdnice	Zagreb		Croatia	10000

Sponsors and Collaborators

University Hospital "Sestre Milosrdnice"
AbbVie

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Karla Randelovic, Study Coordinator, Ophthalmology Consultant, University Hospital "Sestre Milosrdnice"

ClinicalTrials.gov Identifier:

NCT05938985

Other Study ID Numbers:

251-29-11-23-03

First Posted:

Jul 11, 2023

Last Update Posted:

Jul 11, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Study Results

No Results Posted as of Jul 11, 2023