Perichondrium Autograft in Refractory Necrotizing Scleritis

NCT ID: NCT02864823

Last Updated: 2016-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Necrotizing Scleritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Perichondrium

Perichondrium Autografts

Group Type EXPERIMENTAL

Perichondrium Autografts

Intervention Type PROCEDURE

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

Interventions

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Perichondrium Autografts

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

Intervention Type PROCEDURE

Other Intervention Names

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Perichondrium Transplantation

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and ICT, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Jae Chan Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae Chan Kim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

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

Jee Taek Kim, Ph.D.

Role: STUDY_DIRECTOR

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

Locations

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Chung Ang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Koob TJ, Lim JJ, Massee M, Zabek N, Rennert R, Gurtner G, Li WW. Angiogenic properties of dehydrated human amnion/chorion allografts: therapeutic potential for soft tissue repair and regeneration. Vasc Cell. 2014 May 1;6:10. doi: 10.1186/2045-824X-6-10. eCollection 2014.

Reference Type BACKGROUND
PMID: 24817999 (View on PubMed)

Smith JR, Mackensen F, Rosenbaum JT. Therapy insight: scleritis and its relationship to systemic autoimmune disease. Nat Clin Pract Rheumatol. 2007 Apr;3(4):219-26. doi: 10.1038/ncprheum0454.

Reference Type BACKGROUND
PMID: 17396107 (View on PubMed)

Boccieri A, Marianetti TM. Perichondrium graft: harvesting and indications in nasal surgery. J Craniofac Surg. 2010 Jan;21(1):40-4. doi: 10.1097/SCS.0b013e3181c362df.

Reference Type BACKGROUND
PMID: 20061978 (View on PubMed)

Sainz de la Maza M, Foster CS, Jabbur NS. Scleritis associated with systemic vasculitic diseases. Ophthalmology. 1995 Apr;102(4):687-92. doi: 10.1016/s0161-6420(95)30970-0.

Reference Type BACKGROUND
PMID: 7724185 (View on PubMed)

Torchia RT, Dunn RE, Pease PJ. Fascia lata grafting in scleromalacia perforans with lamellar corneal-scleral dissection. Am J Ophthalmol. 1968 Oct;66(4):705-9. doi: 10.1016/0002-9394(68)91293-2. No abstract available.

Reference Type BACKGROUND
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Yalcindag FN, Celik S, Ozdemir O. Repair of anterior staphyloma with dehydrated dura mater patch graft. Ophthalmic Surg Lasers Imaging. 2008 Jul-Aug;39(4):346-7. doi: 10.3928/15428877-20080701-19.

Reference Type BACKGROUND
PMID: 18717447 (View on PubMed)

Breslin CW, Katz JI, Kaufman HE. Surgical management of necrotizing scleritis. Arch Ophthalmol. 1977 Nov;95(11):2038-40. doi: 10.1001/archopht.1977.04450110132017.

Reference Type BACKGROUND
PMID: 921583 (View on PubMed)

Koenig SB, Kaufman HE. The treatment of necrotizing scleritis with an autogenous periosteal graft. Ophthalmic Surg. 1983 Dec;14(12):1029-32.

Reference Type BACKGROUND
PMID: 6672701 (View on PubMed)

Ma DH, Wang SF, Su WY, Tsai RJ. Amniotic membrane graft for the management of scleral melting and corneal perforation in recalcitrant infectious scleral and corneoscleral ulcers. Cornea. 2002 Apr;21(3):275-83. doi: 10.1097/00003226-200204000-00008.

Reference Type BACKGROUND
PMID: 11917176 (View on PubMed)

Sainz de la Maza M, Tauber J, Foster CS. Scleral grafting for necrotizing scleritis. Ophthalmology. 1989 Mar;96(3):306-10. doi: 10.1016/s0161-6420(89)32892-2.

Reference Type BACKGROUND
PMID: 2710520 (View on PubMed)

Araf D, Moura Eda M, Rodrigues CJ, Figueiredo LA. [Homologous scleral and dura mater grafts in rabbit eyes: a comparative histopathological analysis]. Arq Bras Oftalmol. 2007 Nov-Dec;70(6):981-7. doi: 10.1590/s0004-27492007000600018. Portuguese.

Reference Type BACKGROUND
PMID: 18235911 (View on PubMed)

Beaver HA, Patrinely JR, Holds JB, Soper MP. Periocular autografts in socket reconstruction. Ophthalmology. 1996 Sep;103(9):1498-502. doi: 10.1016/s0161-6420(96)30477-6.

Reference Type BACKGROUND
PMID: 8841312 (View on PubMed)

Bairati A, Comazzi M, Gioria M. A comparative study of perichondrial tissue in mammalian cartilages. Tissue Cell. 1996 Aug;28(4):455-68. doi: 10.1016/s0040-8166(96)80031-0.

Reference Type BACKGROUND
PMID: 8760859 (View on PubMed)

Togo T, Utani A, Naitoh M, Ohta M, Tsuji Y, Morikawa N, Nakamura M, Suzuki S. Identification of cartilage progenitor cells in the adult ear perichondrium: utilization for cartilage reconstruction. Lab Invest. 2006 May;86(5):445-57. doi: 10.1038/labinvest.3700409.

Reference Type BACKGROUND
PMID: 16625212 (View on PubMed)

Casas VE, Kheirkhah A, Blanco G, Tseng SC. Surgical approach for scleral ischemia and melt. Cornea. 2008 Feb;27(2):196-201. doi: 10.1097/ICO.0b013e31815ba1ae.

Reference Type BACKGROUND
PMID: 18216576 (View on PubMed)

Seko Y, Azuma N, Takahashi Y, Makino H, Morito T, Muneta T, Matsumoto K, Saito H, Sekiya I, Umezawa A. Human sclera maintains common characteristics with cartilage throughout evolution. PLoS One. 2008;3(11):e3709. doi: 10.1371/journal.pone.0003709. Epub 2008 Nov 12.

Reference Type BACKGROUND
PMID: 19002264 (View on PubMed)

Franz-Odendaal TA, Vickaryous MK. Skeletal elements in the vertebrate eye and adnexa: morphological and developmental perspectives. Dev Dyn. 2006 May;235(5):1244-55. doi: 10.1002/dvdy.20718.

Reference Type BACKGROUND
PMID: 16496288 (View on PubMed)

Watson PG, Hayreh SS, Awdry PN. Episcleritis and scleritis. I. Br J Ophthalmol. 1968 Mar;52(3):278-9 contd. doi: 10.1136/bjo.52.3.278. No abstract available.

Reference Type BACKGROUND
PMID: 5650814 (View on PubMed)

Mamalis N, Johnson MD, Haines JM, Teske MP, Olson RJ. Corneal-scleral melt in association with cataract surgery and intraocular lenses: a report of four cases. J Cataract Refract Surg. 1990 Jan;16(1):108-15. doi: 10.1016/s0886-3350(13)80884-x.

Reference Type BACKGROUND
PMID: 2299561 (View on PubMed)

Other Identifiers

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PCRNS-1

Identifier Type: -

Identifier Source: org_study_id

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