Dry Eye Syndrome (DES)NCT07789054
Ocular Surface Disease Index and Dry Eye Parameters in Hand Osteoarthritis
An observational study of Dry Eye Syndrome (DES) and Hand Osteoarthritis, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome (DES), Hand Osteoarthritis
- What is being tested?
- Dry Eye and Ocular Surface Assessments
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2020to 16 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with dry eye complaints.
- Patients previously diagnosed with hand osteoarthritis according to the American College of Rheumatology (ACR) criteria.
Who cannot join
- Presence of inflammatory rheumatic or autoimmune inflammatory diseases detected by blood tests
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Pendik Hospital
Istanbul
About this study
Official 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
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
- Being tested
- Dry Eye and Ocular Surface Assessments
- Keywords
- Ocular Surface Disease Index, Hand Osteoarthritis, Schirmer Test, Tear Break-Up Time
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Eye and Ocular Surface AssessmentsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Dry Eye and Ocular Surface Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1)
Tear Meniscus Height
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start15 Nov 2020
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Syndrome (DES)Studies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağlayan Aslanbaş, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789054
- Sponsor's protocol ID
- Medipol-764
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07789054
- Acronym / sponsor ID
- Medipol-764
- Conditions
- Dry Eye Syndrome (DES), Hand Osteoarthritis
- Keywords
- Ocular Surface Disease Index, Hand Osteoarthritis, Schirmer Test, Tear Break-Up Time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand Osteoarthritis Cohort | – | Diagnostic Test: Dry Eye and Ocular Surface AssessmentsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Patients with dry eye complaints.
- Patients previously diagnosed with hand osteoarthritis according to the American College of Rheumatology (ACR) criteria.
Key exclusion criteria (1 listed)
- Presence of inflammatory rheumatic or autoimmune inflammatory diseases detected by blood tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Eye and Ocular Surface AssessmentsParticipants 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. | Diagnostic test | Hand Osteoarthritis Cohort |
Primary outcome
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.
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.
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.
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.
Tear Meniscus Height
Time frame: Baseline (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndrome (DES) and Hand Osteoarthritis, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) Total Score (time frame: Baseline (Day 1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.