Ocular Surface Disease Index and Dry Eye Parameters in Hand Osteoarthritis

NCT07789054 | Completed

• 1 other identifier: Medipol-764
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndrome (DES); Hand Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Ocular Surface Disease Index (OSDI) Total Score

  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.

  Baseline (Day 1)

• Basal Tear Secretion via Schirmer I Test

  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.

  Baseline (Day 1)

• Tear Break-Up Time (TBUT)

  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.

  Baseline (Day 1)

• Epithelial Surface Damage (Oxford Grading Scheme)

  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.

  Baseline (Day 1)

• Tear Meniscus Height

  Baseline (Day 1)

Study Arms (1)

Hand Osteoarthritis Cohort

Patients previously diagnosed with hand osteoarthritis according to the American College of Rheumatology (ACR) criteria, presenting with dry eye complaints. Patients with autoimmune inflammatory diseases detected by blood tests were excluded. A total of 23 patients were included in this cohort.

Diagnostic Test: Dry Eye and Ocular Surface Assessments

Interventions

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.

Hand Osteoarthritis Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of volunteered patients from our institution who presented with dry eye complaints and had a prior diagnosis of hand osteoarthritis according to the American College of Rheumatology (ACR) criteria. Patients with concurrent inflammatory rheumatic or autoimmune diseases, detected via blood tests, were excluded from the population to isolate the parameters. The final analyzed cohort comprises 23 patients who met all inclusion criteria and completed the comprehensive ocular surface and dry eye assessments

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Pendik Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 27, 2026
• Study Start: November 15, 2020
• Primary Completion: April 16, 2021
• Study Completion: April 16, 2021
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

TU (1)