Perichondrium Autograft in Refractory Necrotizing Scleritis (PCRNS)

Autologous Perichondrium Transplantation for Replacement of Stem Cells and Their Niche in the Treatment of Necrotizing Scleritis

Necrotizing scleritis with severe ischemia is refractory to conventional treatment because of avascular necrosis.

The investigators assessed the therapeutic efficacy and safety of autologous perichondrium transplantation in patients with severe ischemic necrotizing scleritis, and analyzed the therapeutic effects.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Ischemic necrotizing scleritis patients who showed persistent and progressive scleral melting were included in this study.

Perichondrium tissue was harvested from the patient's ear cartilage and transplanted to reconstruct the scleral defect after the necrotic tissue removal.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. impending perforation or perforation state of sclera;
  2. graft melting following previous surgery;
  3. bacterial or fungal infection of sclera or graft after previous surgery;
  4. discomfort due to protrusion of scleral calcification with ischemic necrosis
  5. broad avascular area larger than 10 mm in diameter

Exclusion Criteria:

  1. asymptomatic patients
  2. smaller scleral defect less than 10 mm in diameter
  3. shallow scleral defect

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perichondrium
Perichondrium Autografts
Perichondrium tissue was harvested from the patient's ear cartilage and transplanted to reconstruct the scleral defect.
Other Names:
  • Perichondrium Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of Repair of Scleral Defects
Time Frame: Six months after reconstructive surgery
Success Rate of Repair of Scleral Defects
Six months after reconstructive surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-Operative Complications
Time Frame: Six months after reconstructive surgery
Six months after reconstructive surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jae Chan Kim, Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine
  • Study Director: Jee Taek Kim, Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 12, 2016

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCRNS-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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