Clinical trial NCT03594370: Multiple Noninvasive Examination Modality to Evaluate the Severity of Ocular Surface Disorders
Official title: Multiple Noninvasive Examination Modality to Evaluate the Severity of Ocular Surface Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Limbal Stem-cell Deficiency
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study is an institutional observation study recruits otherwise healthy patients aging over 5 years old.

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.

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:

  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.

Primary outcomes:
measure: limbal structural abnormality
timeFrame: assess the OCT limbal image at the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: NTUH
name: Wei-Li Chen
role: STUDY_DIRECTOR
References: