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

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ClinicalTrials.gov Identifier: NCT03594370
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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.

Condition or disease
Limbal Stem-cell Deficiency

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.

Study Design
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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Multiple Noninvasive Examination Modality to Evaluate the Severity of Ocular Surface Disorders
Actual Study Start Date : June 8, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : May 22, 2019
Groups and Cohorts
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Group/Cohort
control
Limbal image by OCT in normal subjects.
Advancing wave-like epitheliopathy
Limbal image by OCT in subjects with advancing wave-like epitheliopathy.
Ocular rosacea or phlyctenulosis
Limbal image by OCT in subjects with ocular rosacea or phlyctenulosis


Outcome Measures
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Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
Impression cytology(IC) is a technique which permits the retrieval of the outermost layer of ocular surface cells via the use of various types of filters. It is a minimally invasive method of evaluating human conjunctival epithelial cell morphology. IC may also be utilized in the diagnosis of other ocular diseases, such as ocular surface squamous neoplasia, ocular surface infections, keratoconus and thyroid orbitopathy. IC improves our understanding of the pathophysiology of ocular surface disease, and provide biomarkers to be used as outcome measures in clinical trials.

Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Our study is an institutional observation study recruits otherwise healthy patients aging over 5 years old.
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:

    1. limbal insufficiency
    2. phlyctenulosis
    3. ocular rosacea
    4. ocular graft-versus-host disease (GVHD)
    5. dry eye syndrome (both aqueous deficiency or increased evaporative forms of dry eyes)
    6. other ocular surface diseases (advancing wave-like epitheliopathy, long term use of anti-glaucoma eye drops)

Exclusion Criteria

  • Patients who decline to receive any of the non-invasive examinations mentions in this clinical trial.
  • Patients younger than 5 years old.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594370


Locations
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Taiwan
NTUH
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Director: Wei-Li Chen NTUH
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03594370    
Other Study ID Numbers: 201803133RINC
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No