Necrotizing ScleritisPCRNSNCT02864823

Perichondrium Autograft in Refractory Necrotizing Scleritis

A study testing Perichondrium Autografts in people with Necrotizing Scleritis, run by Chung-Ang University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Necrotizing Scleritis
What is being tested?: Perichondrium Autografts
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteSouth Korea
Study dates: Mar 2011to Jun 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chung Ang University Hospital
Seoul, 156-755

Other trials in South Korea

About this study

Official 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.

Read the 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.

Conditions: Necrotizing Scleritis
Being tested: Perichondrium Autografts
Keywords: Scleromalacia perforans, Necrotizing Scleritis, Perichondrium
Medical subject headings: Scleritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Perichondrium AutograftsProcedure or surgery
Also called Perichondrium Transplantation
Perichondrium tissue was harvested from the patient's ear cartilage and transplanted to reconstruct the scleral defect.

Study groups in NCT02864823
Study group	Role	What they receive
Perichondrium	Experimental	Perichondrium Autografts Receives: Procedure: Perichondrium Autografts

What is being measured

The primary outcome is the main question the study is designed to answer.

Success Rate of Repair of Scleral Defects
Success Rate of Repair of Scleral Defects
Measured: Six months after reconstructive surgery

Secondary outcomes (1)

Post-Operative Complications
Measured: Six months after reconstructive surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Jun 2016

First posted12 Aug 2016 (estimated)
Study startMar 2011
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Necrotizing ScleritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02864823
Sponsor's protocol ID: PCRNS-1
Acronym: PCRNS
Status last verified: Aug 2016
First submitted: 21 Jul 2016
Last updated: 12 Aug 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

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.
PubMed 5650814
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.
PubMed 2299561
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.
PubMed 7724185
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.
PubMed 5729586
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.
PubMed 18717447
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.
PubMed 921583
Koenig SB, Kaufman HE. The treatment of necrotizing scleritis with an autogenous periosteal graft. Ophthalmic Surg. 1983 Dec;14(12):1029-32.
PubMed 6672701
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.
PubMed 11917176
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.
PubMed 2710520
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.
PubMed 18235911
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.
PubMed 8841312
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.
PubMed 8760859
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.
PubMed 16625212
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.
PubMed 18216576
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.
PubMed 19002264

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Autologous Perichondrium Transplantation for Replacement of Stem Cells and Their Niche in the Treatment of Necrotizing Scleritis
ClinicalTrials.gov ID: NCT02864823
Acronym / sponsor ID: PCRNS / PCRNS-1
Conditions: Necrotizing Scleritis
Keywords: Scleromalacia perforans, Necrotizing Scleritis, Perichondrium
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Chung-Ang University HospitalUniversity, hospital or other
Collaborators: Ministry of Science and ICT, Republic of Korea
Study start: Mar 2011
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 12 Aug 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Necrotizing scleritis with severe ischemia is refractory to conventional treatment because of avascular necrosis.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Perichondrium	Experimental	Procedure: Perichondrium AutograftsPerichondrium Autografts

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Perichondrium AutograftsAlso: Perichondrium TransplantationPerichondrium tissue was harvested from the patient's ear cartilage and transplanted to reconstruct the scleral defect.	Procedure or surgery	Perichondrium

Primary outcome

Success Rate of Repair of Scleral Defects
Time frame: Six months after reconstructive surgery
Success Rate of Repair of Scleral Defects

1 secondary outcome

Post-Operative Complications
Time frame: Six months after reconstructive surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
Background: PubMed 5650814Watson 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.
Background: PubMed 2299561Mamalis 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.
Background: PubMed 7724185Sainz 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.
Background: PubMed 5729586Torchia 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.
Background: PubMed 18717447Yalcindag 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.
Background: PubMed 921583Breslin CW, Katz JI, Kaufman HE. Surgical management of necrotizing scleritis. Arch Ophthalmol. 1977 Nov;95(11):2038-40. doi: 10.1001/archopht.1977.04450110132017.
Background: PubMed 6672701Koenig SB, Kaufman HE. The treatment of necrotizing scleritis with an autogenous periosteal graft. Ophthalmic Surg. 1983 Dec;14(12):1029-32.
Background: PubMed 11917176Ma 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.
Background: PubMed 2710520Sainz 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.
Background: PubMed 18235911Araf 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.
Background: PubMed 8841312Beaver 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.
Background: PubMed 8760859Bairati 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.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jae Chan Kim, Ph.D. principal investigator

Chung-Ang University Hospital

Jee Taek Kim, Ph.D. study director

Chung-Ang University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Perichondrium Autografts in people with Necrotizing Scleritis, run by Chung-Ang University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success Rate of Repair of Scleral Defects (time frame: Six months after reconstructive surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864823, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.