NCT02864823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

5.3 years

First QC Date

July 21, 2016

Last Update Submit

August 9, 2016

Conditions

Necrotizing Scleritis

Keywords

Scleromalacia perforansNecrotizing ScleritisPerichondrium

Outcome Measures

Primary Outcomes (1)

  • Success Rate of Repair of Scleral Defects

    Success Rate of Repair of Scleral Defects

    Six months after reconstructive surgery

Secondary Outcomes (1)

  • Post-Operative Complications

    Six months after reconstructive surgery

Study Arms (1)

Perichondrium

EXPERIMENTAL

Perichondrium Autografts

Procedure: Perichondrium Autografts

Interventions

Perichondrium AutograftsPROCEDURE

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

Also known as: Perichondrium Transplantation
Perichondrium

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • asymptomatic patients
  • smaller scleral defect less than 10 mm in diameter
  • shallow scleral defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Ang University Hospital

Seoul, 156-755, South Korea

Location

Related Publications (19)

  • 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.

    PMID: 5650814BACKGROUND

  • 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.

    PMID: 2299561BACKGROUND

  • 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.

    PMID: 7724185BACKGROUND

  • 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.

    PMID: 5729586BACKGROUND

  • 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.

    PMID: 18717447BACKGROUND

  • 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.

    PMID: 921583BACKGROUND

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

    PMID: 6672701BACKGROUND

  • 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.

    PMID: 11917176BACKGROUND

  • 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.

    PMID: 2710520BACKGROUND

  • 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.

    PMID: 18235911BACKGROUND

  • 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.

    PMID: 8841312BACKGROUND

  • 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.

    PMID: 8760859BACKGROUND

  • 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.

    PMID: 16625212BACKGROUND

  • 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.

    PMID: 18216576BACKGROUND

  • 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.

    PMID: 19002264BACKGROUND

  • 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.

    PMID: 16496288BACKGROUND

  • 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.

    PMID: 24817999BACKGROUND

  • 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.

    PMID: 17396107BACKGROUND

  • 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.

    PMID: 20061978BACKGROUND

MeSH Terms

Conditions

Scleritis

Condition Hierarchy (Ancestors)

Scleral DiseasesEye Diseases

Study Officials

  • Jae Chan Kim, Ph.D.

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

    PRINCIPAL INVESTIGATOR

  • Jee Taek Kim, Ph.D.

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 12, 2016

Study Start

March 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 12, 2016

Record last verified: 2016-08

Locations

KR(1)