The Marker Expression of Corneal Surface From Penetrating Keratopathy After Collagenase A Assisted COMET Case Series

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.

Study Overview

• Status: Unknown
• Conditions: Cornea
• Intervention / Treatment: Other: specimen

Detailed Description

Limbal insufficiency may cause persistent corneal erosion, turbidity, and even infection and blindness, leading to major eye damage. In patients with limbal stem cell insufficiency, due to the defect of the limbal stem cells, the new epidermal cells cannot be produced, and without the limbus as a barrier, the cells near the conjunctiva will move toward the center of the cornea, result in replacing the corneal cells and causing corneal conjunctivalization.

In recent years, many surgical methods for treating corneal stem cell defects include amniotic membrane transplantation, autologous limbal cell transplantation, and allogeneic limbal cell transplantation. However, in patients with bilateral total limbal insufficiency, there are no autologous limbal cells in the contralateral eye, and allografts may also have rejection and infection.

Cultured oral mucosa epithelium transplant is a method for treating bilateral full-limbal cell defects. The patient's own oral mucosal cells are cultured in the laboratory, and the cultured epithelium is transplanted to the patient's limbus. In the experiment, mouse cells are used as a feeder cell and transplanted to the human body, which is prone to potential problems such as rejection or infection. In order to resolve these problems, our laboratory modified the process of separating the limbal stem cells. By replacing the dispase II/trypsin-EDTA with Collagenase A, there were no needs to use a feeder cell. This experiment has been successfully completed under the national plan.

In this study, we want to investigate the cells on the ocular surface form the four patients who underwent corneal transplantation after receiving CA-COMET.

Dr.Kuan-Ting Kuo, a pathologist in NTUH, will assist us in the staining of the specimens of the cornea from four patients who underwent corneal transplantation after receiving CA-COMET. The specimens of the four patients will be stained (Immunohistochemistry) with markers of the cornea and conjunctival cells (K3, K4, K12, K13, K19, MUC5, P63).

• Study Type: Observational
• Enrollment (Anticipated): 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei city, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Wei-Li Chen; Phone Number: 02-23123456; Email: chenweili@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Wei-Li Chen, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): August 6, 2020
• Study Completion (Anticipated): August 6, 2020

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 201905046RINC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No