Necrotizing Scleritis Clinical Trial
— PCRNSOfficial title:
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Chung Ang University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Chung-Ang University Hosptial, Chung-Ang University College of Medicine | Ministry of Science, ICT and Future Planning |
Korea, Republic of,
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* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Success Rate of Repair of Scleral Defects | Success Rate of Repair of Scleral Defects | Six months after reconstructive surgery | No |
| Secondary | Post-Operative Complications | Six months after reconstructive surgery | Yes |