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Clinical Trials/NCT03594370
NCT03594370
Completed
Not Applicable

Multiple Noninvasive Examination Modality to Evaluate the Severity of Ocular Surface Disorders

National Taiwan University Hospital1 site in 1 country25 target enrollmentJune 8, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Limbal Stem-cell Deficiency
Sponsor
National Taiwan University Hospital
Enrollment
25
Locations
1
Primary Endpoint
limbal structural abnormality
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Here the investigators proposed this study to collect cases of different etiologies of ocular surface diseases. With at least one of these four non-invasive examination modalities, the investigators aim to analyze and compare the detecting results. The investigators especially focus on the possibility of using OCT to predict the condition of limbal epithelial stem cells, aiming to use this patient-friendly tool to detect the patient's limbal conditions.

Detailed Description

In vivo confocal microscopy, anterior segment optical coherence tomography, keratograph and impression cytology are noninvasive, rapid and easily repeatable technique to investigate ocular surface disorders. In vivo confocal microscopy (IVCM) enables morphological and quantitative analysis of ocular surface microstructure. Optical coherence tomography (OCT) allows for imaging of the morphology of biological tissue with micrometer scale resolution at imaging depths of 1 to 2mm below the tissue surface. \[1,2\] Anterior segment OCT (ASOCT) has been developed to evaluate corneal diseases\[3-8\] in different layers. Keratography includes noninvasive meibography and tear interferometry. The former demonstrates the morphology of meibomian glands whereas the later observes quality and quantity of the lipid layer of the tear film. Impression cytology shows the morphology of the corneal and conjunctival epithelial cells, their staining behavior, and nuclear/cytoplasmic ratio could be observed in detail. Here the investigators proposed this clinical trial to collect cases of different etiologies of ocular surface diseases. With at least one of these four non-invasive examination modalities, the investigators aim to analyze and compare the detecting results. The investigators especially focus on the possibility of using ASOCT to predict the condition of limbal epithelial stem cells, aiming to use this patient-friendly tool to detect the patient's limbal conditions.

Registry
clinicaltrials.gov
Start Date
June 8, 2018
End Date
May 22, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient who is able to understand and cooperate with the examination: aged over 5 years.
  • Patient or the legal representative is able to read and sign an informed consent form.
  • Patient with one of the diagnosis listed below:
  • limbal insufficiency
  • phlyctenulosis
  • ocular rosacea
  • ocular graft-versus-host disease (GVHD)
  • dry eye syndrome (both aqueous deficiency or increased evaporative forms of dry eyes)
  • other ocular surface diseases (advancing wave-like epitheliopathy, long term use of anti-glaucoma eye drops)
  • Exclusion Criteria

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

limbal structural abnormality

Time Frame: assess the OCT limbal image at the baseline

atypical pattern of limbal Palisade of Vogt detected by OCT comparing to normal subjects

Study Sites (1)

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