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Perichondrium Autograft in Refractory Necrotizing Scleritis (PCRNS)

C

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Status

Completed

Conditions

Necrotizing Scleritis

Treatments

Procedure: Perichondrium Autografts

Study type

Interventional

Funder types

Other

Identifiers

NCT02864823
PCRNS-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Perichondrium
Experimental group
Description:
Perichondrium Autografts
Treatment:
Procedure: Perichondrium Autografts

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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