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Ocular Surface Disease Index and Dry Eye Parameters in Hand Osteoarthritis

Evaluation of Relationship Between Ocular Surface Disease Index and Test Parameters of Dry Eye in Patients With Hand Osteoarthritis: The Search for a New Predictive Marker

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07789054
Enrollment
23
Registered
2026-08-27
Start date
2020-11-15
Completion date
2021-04-16
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndrome (DES), Hand Osteoarthritis

Keywords

Ocular Surface Disease Index, Hand Osteoarthritis, Schirmer Test, Tear Break-Up Time

Brief summary

This study investigates whether the relationship between the Ocular Surface Disease Index (OSDI) and dry eye parameters can be used as a predictive marker in patients diagnosed with hand osteoarthritis. Symptoms and signs of dry eye are assessed using the OSDI questionnaire, Schirmer I-II tests, tear break-up time (TBUT), Oxford Grading Scheme for surface staining, and optical coherence tomography (OCT) for tear meniscus height.

Interventions

DIAGNOSTIC_TESTDry Eye and Ocular Surface Assessments

Participants underwent a series of ocular assessments, including Schirmer I and II tests to assess basal tear secretion, Tear Break-Up Time (TBUT) to measure tear film stability, and Optical Coherence Tomography (OCT) to evaluate tear meniscus height. Ocular surface damage was quantified using the Oxford grading scheme after corneal and conjunctival staining. Additionally, patient symptoms were assessed using the Ocular Surface Disease Index (OSDI) questionnaire.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with dry eye complaints. * Patients previously diagnosed with hand osteoarthritis according to the American College of Rheumatology (ACR) criteria.

Exclusion criteria

* Presence of inflammatory rheumatic or autoimmune inflammatory diseases detected by blood tests

Design outcomes

Primary

MeasureTime frameDescription
Ocular Surface Disease Index (OSDI) Total ScoreBaseline (Day 1)Patient symptoms of dry eye were assessed using the 12-item OSDI questionnaire. The total score ranges from 0 to 100. Higher scores indicate more severe symptoms, with 0-12 considered normal, 13-22 mild, 23-32 moderate, and 33-100 indicating severe ocular surface disease.
Basal Tear Secretion via Schirmer I TestBaseline (Day 1)Basal tear secretion was evaluated using the Schirmer I Test. The measurement is recorded as the length of tear wetting on a standard filter paper strip in millimeters (mm) over a 5-minute period. The measurable range is typically from a minimum of 0 mm to a maximum of 35 mm. Higher values indicate greater tear production, representing better tear function and a better clinical outcome.
Tear Break-Up Time (TBUT)Baseline (Day 1)Tear film stability was evaluated using the Tear Break-Up Time (TBUT) test. The measurement is recorded in seconds, representing the time elapsed before the first dry spot appears on the cornea after a complete blink. The minimum possible value is 0 seconds, with no defined upper limit. Higher values (a longer time before break-up) indicate better tear film stability, representing a better clinical outcome.
Epithelial Surface Damage (Oxford Grading Scheme)Baseline (Day 1)Corneal and conjunctival epithelial surface damage was evaluated using the Oxford Grading Scheme. The severity of staining is graded on a scale ranging from a minimum of 0 (no damage) to a maximum of 5 (severe damage). Higher scores indicate greater epithelial surface damage, representing a worse clinical outcome.
Tear Meniscus HeightBaseline (Day 1)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026