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Completed

NCT Number: NCT02864823

Perichondrium Autograft in Refractory 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.

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Key information

Conditions

Necrotizing Scleritis Eye Diseases Scleral Diseases Scleritis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Ang University Hospital

Seoul, 156-755, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perichondrium Autografts

Procedure

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

Other names: Perichondrium Transplantation

Primary outcomes

  1. Success Rate of Repair of Scleral Defects

    Time frame: Six months after reconstructive surgery

    Success Rate of Repair of Scleral Defects

Secondary outcomes

  1. Post-Operative Complications

    Time frame: Six months after reconstructive surgery

Sponsors and collaborators

Lead sponsor

Chung-Ang University Hospital

Other

Collaborators

  • Ministry of Science and ICT, Republic of Korea

Registry information

Official study title

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

Acronym: PCRNS

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 12, 2016
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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