NCT04066439

Brief Summary

In order to examine the cells of the corneal epithelium in the patients who receive corneal transplantation after collagenase A assisted cultivated oral mucosa epithelium transplant (CA-COMET), we analyzed the specimens from penetrating keratoplasty with immunochemical staining.

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
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2020

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

August 15, 2019

Last Update Submit

August 22, 2019

Conditions

Cornea

Outcome Measures

Primary Outcomes (1)

  • Immunofluorescence staining

    Using fluorescence microscope to detect specific biomolecule targets with markers of the cornea and conjunctival cells (K3, K4, K12, K13, K19, MUC5, P63)

    1 year

Interventions

specimenOTHER

Immunohistochemistry analysis

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who underwent corneal transplantation after receiving CA-COMET in five years.

You may qualify if:

  • The patients who underwent corneal transplantation after receiving CA-COMET in five years.

You may not qualify if:

  • The patients who NEVER underwent corneal transplantation after receiving CA-COMET.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cornea biopsy

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Wei-Li Chen

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Wei-Li Chen

CONTACT

02-23123456chenweili@ntu.edu.tw

Kuan-Ting Kuo

CONTACT

02-23123456kuokt@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 26, 2019

Study Start

August 1, 2019

Primary Completion

August 6, 2020

Study Completion

August 6, 2020

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

TW(1)