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Perichondrium Autograft in Refractory Necrotizing Scleritis (PCRNS)

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ClinicalTrials.gov Identifier: NCT02864823
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Collaborator:
Ministry of Science, ICT and Future Planning
Information provided by (Responsible Party):
Jae Chan Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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
Necrotizing Scleritis Procedure: Perichondrium Autografts Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : March 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: Perichondrium Transplantation




Primary Outcome Measures :
  1. Success Rate of Repair of Scleral Defects [ Time Frame: Six months after reconstructive surgery ]
    Success Rate of Repair of Scleral Defects


Secondary Outcome Measures :
  1. Post-Operative Complications [ Time Frame: Six months after reconstructive surgery ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864823


Locations
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Korea, Republic of
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
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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:

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Responsible Party: Jae Chan Kim, Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
ClinicalTrials.gov Identifier: NCT02864823     History of Changes
Other Study ID Numbers: PCRNS-1
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jae Chan Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine:
Scleromalacia perforans
Necrotizing Scleritis
Perichondrium

Additional relevant MeSH terms:
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Scleritis
Scleral Diseases
Eye Diseases