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Completed

NCT Number: NCT03594370

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

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.

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Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NTUH

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Patients who decline to receive any of the non-invasive examinations mentions in this clinical trial.
  • Patients younger than 5 years old.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 20, 2018
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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