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Clinical Trials/ISRCTN61064041
ISRCTN61064041
Completed
未知

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

uzerner Kantonsspital0 sites75 target enrollmentDecember 24, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Dry eye syndrome, dry eye disease
Sponsor
uzerner Kantonsspital
Enrollment
75
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Registry
who.int
Start Date
December 24, 2020
End Date
May 4, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
uzerner Kantonsspital

Eligibility Criteria

Inclusion Criteria

  • All participants:
  • 1\. Aged between 18 and 79 years
  • 2\. Given consent and signed the consent form declaration
  • 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

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

Outcomes

Primary Outcomes

Not specified

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