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

Limbal Stem-cell Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594370
• Other study ID #: 201803133RINC
• Status: Completed
• Start date: June 8, 2018
• Est. completion date: May 22, 2019

Study information

• Verified date: May 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 22, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Limbal Stem-cell Deficiency

Locations

Country	Name	City	State
Taiwan	NTUH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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