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

NCT05938985 | Unknown

• 1 other identifier: 251-29-11-23-03
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Dry Eye; Ocular Surface Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cro-OSDI score comparison with the NEI VFQ-25 score

  2 months

• Cro-OSDI score comparison with the Oxford scale, SICCA scale, scaled filter paper strips.

  2 months

Study Arms (2)

with dry eye disease (DED)

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

Diagnostic Test: Questionnaires and dry eye tests

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

Interventions

Questionnaires and dry eye tests DIAGNOSTIC_TEST

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); with dry eye disease (DED)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that are coming for an examination to an ophthalmology department of University Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead
• AbbVie: collaborator

Study Sites (1)

University Hospital Sestre milosrdnice

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator, Ophthalmology Consultant

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: July 11, 2023
• Study Start: June 12, 2023
• Primary Completion: October 31, 2023
• Study Completion: November 2, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

CR (1)