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PCRNS: Perichondrium Autograft in Refractory Necrotizing Scleritis

Sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02864823
Collaborator
Ministry of Science, ICT and Future Planning (Other)
20
Enrollment
1
Location
1
Arm
63
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Perichondrium Autografts
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Autologous Perichondrium Transplantation for Replacement of Stem Cells and Their Niche in the Treatment of Necrotizing Scleritis
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Perichondrium

Perichondrium Autografts

Procedure: Perichondrium Autografts
Perichondrium tissue was harvested from the patient's ear cartilage and transplanted to reconstruct the scleral defect.
Other Names:
  • Perichondrium Transplantation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Success Rate of Repair of Scleral Defects [Six months after reconstructive surgery]

      Success Rate of Repair of Scleral Defects

    Secondary Outcome Measures

    1. Post-Operative Complications [Six months after reconstructive surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chung Ang University Hospital Seoul Korea, Republic of 156-755

    Sponsors and Collaborators

    • Chung-Ang University Hosptial, Chung-Ang University College of Medicine
    • Ministry of Science, ICT and Future Planning

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jae Chan Kim, Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
    ClinicalTrials.gov Identifier:
    NCT02864823
    Other Study ID Numbers:
    • PCRNS-1
    First Posted:
    Aug 12, 2016
    Last Update Posted:
    Aug 12, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Jae Chan Kim, Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
    Scleromalacia perforans
    Necrotizing Scleritis
    Perichondrium
    Additional relevant MeSH terms:
    Scleritis

    Study Results

    No Results Posted as of Aug 12, 2016