Multiple Noninvasive Examination Modality to Evaluate the... | NCT03594370

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

NCT03594370

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Jul 26, 2019Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Limbal Stem-cell Deficiency

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 8, 2018Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

May 22, 2019Actual

First Submitted Date

Jul 1, 2018

First Submission Date that Met QC Criteria

Jul 18, 2018

First Posted Date

Jul 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2019

Last Update Posted Date

Jul 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Wei-Li Chen	NTUH	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000092423	Limbal Stem Cell Deficiency

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Description

Impression cytology(IC) is a technique which permits the retrieval of the outermost layer of ocular surface cells via the use of various types of filters. It is a minimally invasive method of evaluating human conjunctival epithelial cell morphology. IC may also be utilized in the diagnosis of other ocular diseases, such as ocular surface squamous neoplasia, ocular surface infections, keratoconus and thyroid orbitopathy. IC improves our understanding of the pathophysiology of ocular surface disease, and provide biomarkers to be used as outcome measures in clinical trials.