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Testing of a new measurement procedure for dry eye diagnosis on patients and healthy subjects

Evaluation of non-invasive automatic measurement protocol for dry eye diagnosis in patients with dry eye disease and control subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN61064041
Enrollment
66
Registered
2020-12-24
Start date
2021-01-01
Completion date
Unknown
Last updated
2024-01-15

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

Conditions

Dry eye syndrome, dry eye disease Eye Diseases Dry eye syndrome, dry eye disease

Interventions

Tear film condition will be explored in both patients showing dry eye disease (DED) symptoms and control subjects. Non-invasive tear film break-up time, tear meniscus height, lipid layer interferometr

Sponsors

Luzerner Kantonsspital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All participants: 1. Aged between 18 and 79 years 2. Given consent and signed the consent form declaration Patients: 1. Ocular Surface Disease Index (OSDI©) score =13 2. At least one of the following: 2.1. Image result for tear break-up time (TBUT) of =10 sec 2.2. Corneal staining grading =grade II 2.3. Schirmer test =10 mm in 5 min Control subjects: 1. OSDI© score <13 2. Absence of sensitivity to light, ocular grittiness, ocular pain or soreness, blurred vision, poor vision, and eye redness

Exclusion criteria

Exclusion criteria: 1. Eyelid deformities or eyelid motility disorders (such as incomplete lid closure, entropium, ectropium, hordeola, or chalazia) 2. Previous ocular disease leaving sequelae or requiring current topical eye therapy 3. Active ocular allergy 4. Known hypersensitivity to sodium fluorescein or oxybuprocaine 5. LASIK or PRK surgery performed 6. Punctal plugs or cauterization within the past 30 days 7. Abormality of nasolacrimal drainage 8. Pregnancy or lactation 9. Systemic disease known to affect tear production or loss, diagnosed or being instable within the past 30 days 10. Started or changed dose of chronic systemic medication known to affect tear production within the past 30 days 11. Any eye drops within the past 8 h 12. Contact lens worn within the past 8 h

Design outcomes

Primary

MeasureTime frame
1. Classification performance (the proportion of subjects with dry eye disease correctly classified with a positive index test result and the proportion of healthy subjects correctly classified with a positive index test result) measured using the IDRA system to assess non-invasive tear film break-up time (NIBUT) at a single time point

Secondary

MeasureTime frame
1. Classification performance of lipid layer interferometry measured using the IDRA system at a single time point 2. Classification performance of tear meniscus height measured using the IDRA system at a single time point 3. Classification performance of meibography measured using the IDRA system at a single time point 4. Classification performance of routine diagnostic procedures including tear film break-up time, biomicroscopic slit lamp examination, meibomian dysfunction testing, corneal staining, and Schirmer's test at a single time point

Countries

Switzerland

Contacts

Public ContactPhilipp B;Janosch Bänninger;Rinert

;

philipp.baenninger@gmail.com;janosch.rinert@bluewin.ch+41 41 205 34 10;+41 79 575 71 61

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026