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

Not Applicable

Completed

• Conditions: Eye Diseases; Dry eye syndrome, dry eye disease

• Registration Number: ISRCTN61064041
• Lead Sponsor: uzerner Kantonsspital

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35543570/ (added 29/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-24
• Study Completion: 2021-05-04
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Classification performance of lipid layer interferometry measured using the IDRA system at a single time point<br> 2. Classification performance of tear meniscus height measured using the IDRA system at a single time point<br> 3. Classification performance of meibography measured using the IDRA system at a single time point<br> 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<br>