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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • NTUH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Our study is an institutional observation study recruits otherwise healthy patients aging over 5 years old.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
limbal structural abnormality	atypical pattern of limbal Palisade of Vogt detected by OCT comparing to normal subjects	assess the OCT limbal image at the baseline

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Wei-Li Chen, NTUH

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): May 22, 2019

Study Registration Dates

• First Submitted: July 1, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 201803133RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No