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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03594370
Collaborator
(none)
25
1
11.4
2.2

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Jun 8, 2018
    Actual Primary Completion Date :
    Jan 31, 2019
    Actual Study Completion Date :
    May 22, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. limbal structural abnormality [assess the OCT limbal image at the baseline]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 NTUH Taipei Taiwan

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Study Director: Wei-Li Chen, NTUH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03594370
    Other Study ID Numbers:
    • 201803133RINC
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    Jul 26, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 26, 2019