Clinical trial NCT02864823: Perichondrium Autograft in Refractory Necrotizing Scleritis
Official title: Autologous Perichondrium Transplantation for Replacement of Stem Cells and Their Niche in the Treatment of Necrotizing Scleritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Necrotizing Scleritis
Keywords: Scleromalacia perforans
Necrotizing Scleritis
Perichondrium
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Science and ICT, Republic of Korea
First posted: 2016-08-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Success Rate of Repair of Scleral Defects
timeFrame: Six months after reconstructive surgery
Secondary outcomes:
measure: Post-Operative Complications
timeFrame: Six months after reconstructive surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Jae Chan Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Jee Taek Kim, Ph.D.
role: STUDY_DIRECTOR
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