NCT02500134

Brief Summary

The limbus located between the cornea and the conjunctiva tissue, is important for not only providing a barrier frontier to prevent conjunctival tissue invasion into the cornea, containing nerves passing to the cornea, having blood and lymph vasculature for oxygen and nutrient delivery, but also the niche environment of limbal stem cells. So far, in vivo image systems are not able to visualize or identify the limbal stem cells directly. One alternative practical is to visualize the histological morphology of palisades of Vogt (POV), and to speculate the possible status of the stem cells accordingly. Slit-lamp biomicroscope can be used routinely for clinical examination of the limbal morphology. However, this technology does not allow for high resolution imaging of structural details and only up to 20% of patients can be identified. In vivo confocal microscopy has been used to visualize the POV and can provide cellular level resolution images, but the technique is limited by high magnification that restricts the area of the scan, and requires contact with the eye. Besides, both slit lamp biomicroscopy and in vivo confocal microscopy have the limitation of not being able to give an overall view of the dimension and structure of the whole palisades region. Anterior segment optical coherence tomography (AS-OCT) is a noninvasive, rapid and reproducible technique to evaluate the anterior segment and can also provide in vivo spatial information. The purpose of the study is to assess the role of aging and regions on the limbus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

1.4 years

First QC Date

August 7, 2014

Last Update Submit

July 15, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • thickness of limbus

    measure the thickness of limbus from the image of OCT, describe the morphology of limbus (typical pattern was defined as having the easily identified sharp tapering tip of subepithelial stroma pointing to the corneal-limbal junction with the maximum epithelial thickness of palisades of Vogt at least 1.5 X thicker than the central corneal epithelial thickness)

    1 day of inclusion

Study Arms (1)

Normal

Healthy volunteer control without ocular surface disease or prior ophthalmic surgery history

Other: Optical coherence tomography study on limbus

Interventions

Optical coherence tomography study on limbus

Normal

Eligibility Criteria

Age6 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy normal eyes without any ocular surface disease

You may qualify if:

  • Healthy volunteer control without ocular surface disease or prior ophthalmic surgery history

You may not qualify if:

  • Patients who decline to receive the diagnostic examinations.
  • Patients younger than 6 years old or older than 90 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

Study Officials

  • Wei-Li Chen, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 7, 2014

First Posted

July 16, 2015

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2017

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations