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Perichondrium Autograft in Refractory Necrotizing Scleritis (PCRNS)

Primary Purpose

Necrotizing Scleritis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Perichondrium Autografts
Sponsored by
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotizing Scleritis focused on measuring Scleromalacia perforans, Necrotizing Scleritis, Perichondrium

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung Ang University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perichondrium

Arm Description

Perichondrium Autografts

Outcomes

Primary Outcome Measures

Success Rate of Repair of Scleral Defects
Success Rate of Repair of Scleral Defects

Secondary Outcome Measures

Post-Operative Complications

Full Information

First Posted
July 21, 2016
Last Updated
August 9, 2016
Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Collaborators
Ministry of Science, ICT and Future Planning
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1. Study Identification

Unique Protocol Identification Number
NCT02864823
Brief Title
Perichondrium Autograft in Refractory Necrotizing Scleritis
Acronym
PCRNS
Official Title
Autologous Perichondrium Transplantation for Replacement of Stem Cells and Their Niche in the Treatment of Necrotizing Scleritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Collaborators
Ministry of Science, ICT and Future Planning

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Scleritis
Keywords
Scleromalacia perforans, Necrotizing Scleritis, Perichondrium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perichondrium
Arm Type
Experimental
Arm Description
Perichondrium Autografts
Intervention Type
Procedure
Intervention Name(s)
Perichondrium Autografts
Other Intervention Name(s)
Perichondrium Transplantation
Intervention Description
Perichondrium tissue was harvested from the patient's ear cartilage and transplanted to reconstruct the scleral defect.
Primary Outcome Measure Information:
Title
Success Rate of Repair of Scleral Defects
Description
Success Rate of Repair of Scleral Defects
Time Frame
Six months after reconstructive surgery
Secondary Outcome Measure Information:
Title
Post-Operative Complications
Time Frame
Six months after reconstructive surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: impending perforation or perforation state of sclera; graft melting following previous surgery; bacterial or fungal infection of sclera or graft after previous surgery; discomfort due to protrusion of scleral calcification with ischemic necrosis broad avascular area larger than 10 mm in diameter Exclusion Criteria: asymptomatic patients smaller scleral defect less than 10 mm in diameter shallow scleral defect
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Chan Kim, Ph.D.
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jee Taek Kim, Ph.D.
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Chung Ang University Hospital
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Perichondrium Autograft in Refractory Necrotizing Scleritis

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