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

NCT03594370 | Completed

• 1 other identifier: 201803133RINC
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Limbal Stem-cell Deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

NTUH

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Wei-Li Chen

  NTUH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 20, 2018
• Study Start: June 8, 2018
• Primary Completion: January 31, 2019
• Study Completion: May 22, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)