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NCT Number: NCT07789054

Ocular Surface Disease Index and Dry Eye Parameters in Hand Osteoarthritis

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.

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Key information

Conditions

Dry Eye Syndrome (DES) Dry Eye Syndromes Eye Diseases Hand Osteoarthritis Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medipol University Pendik Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dry Eye and Ocular Surface Assessments

Diagnostic Test

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.

Primary outcomes

  1. Ocular Surface Disease Index (OSDI) Total Score

    Time frame: Baseline (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.

  2. Basal Tear Secretion via Schirmer I Test

    Time frame: Baseline (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.

  3. Tear Break-Up Time (TBUT)

    Time frame: 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.

  4. Epithelial Surface Damage (Oxford Grading Scheme)

    Time frame: 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.

  5. Tear Meniscus Height

    Time frame: Baseline (Day 1)

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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