Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia

NCT ID: NCT02911532

Last Updated: 2017-08-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-04-01

Brief Summary

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The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.

Detailed Description

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The most important area for research on the pterygium are the recurrence occurred after operation. Now the best way to prevent the recurrence is autologous conjunctival stem cell transplantation, but this way of operation can cause lack of conjunctiva and conjunctival scar, even may effect the later glaucoma surgery. For the atretoblepharia patients, amniotic membrane transplantation and autologous oral mucosa transplantation can not make effect to alleviate it. In this pilot project, investigators would like to study the effect of tissue engineering conjunctiva transplantation in the treatment of pterygium and tissue engineering conjunctiva transplantation combined with conjunctiva sac formation for the treatment of atretoblepharia. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various conjunctiva loss caused by trauma, infections, and so on.

Conditions

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Pterygium

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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Optical Coherence tomography

Group Type EXPERIMENTAL

Tissue engineering conjunctiva transplantation

Intervention Type PROCEDURE

During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position

Interventions

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Tissue engineering conjunctiva transplantation

During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Primary and recurrent pterygium patients,atretoblepharia patients
2. Voluntarily signed informed consent
3. No surgery and anesthesia contraindications.

Exclusion Criteria

1. The patients combined systemic diseases
2. Reject study and follow visit
3. Patients don't accept the tissue engineering conjunctiva
4. Cannot tolerate surgery or anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weiyun Shi, sponsor

Role: STUDY_CHAIR

director of shandong eye hospital

Locations

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Shandong Eye Hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Suxia Li, researcher

Role: CONTACT

8615854107085

Hua Gao, researcher

Role: CONTACT

8613705312702

Facility Contacts

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Suxia Li

Role: primary

15854107085

References

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Varssano D, Shalev H, Lazar M, Fischer N. Pterygium excision with conjunctival autograft: true survival rate statistics. Cornea. 2013 Sep;32(9):1243-50. doi: 10.1097/ICO.0b013e31828ce09c.

Reference Type BACKGROUND
PMID: 23594771 (View on PubMed)

Mahar PS, Manzar N. The study of etiological and demographic characteristics of pterygium recurrence: a consecutive case series study from Pakistan. Int Ophthalmol. 2014 Feb;34(1):69-74. doi: 10.1007/s10792-013-9797-4. Epub 2013 Jun 18.

Reference Type BACKGROUND
PMID: 23775605 (View on PubMed)

Farid M, Pirnazar JR. Pterygium recurrence after excision with conjunctival autograft: a comparison of fibrin tissue adhesive to absorbable sutures. Cornea. 2009 Jan;28(1):43-5. doi: 10.1097/ICO.0b013e318183a362.

Reference Type BACKGROUND
PMID: 19092404 (View on PubMed)

Kaufman SC, Jacobs DS, Lee WB, Deng SX, Rosenblatt MI, Shtein RM. Options and adjuvants in surgery for pterygium: a report by the American Academy of Ophthalmology. Ophthalmology. 2013 Jan;120(1):201-8. doi: 10.1016/j.ophtha.2012.06.066. Epub 2012 Oct 11.

Reference Type BACKGROUND
PMID: 23062647 (View on PubMed)

Tan DT, Chee SP, Dear KB, Lim AS. Effect of pterygium morphology on pterygium recurrence in a controlled trial comparing conjunctival autografting with bare sclera excision. Arch Ophthalmol. 1997 Oct;115(10):1235-40. doi: 10.1001/archopht.1997.01100160405001.

Reference Type BACKGROUND
PMID: 9338666 (View on PubMed)

Sandra S, Zeljka J, Zeljka VA, Kristian S, Ivana A. The influence of pterygium morphology on fibrin glue conjunctival autografting pterygium surgery. Int Ophthalmol. 2014 Feb;34(1):75-9. doi: 10.1007/s10792-013-9799-2. Epub 2013 Jun 4.

Reference Type BACKGROUND
PMID: 23733279 (View on PubMed)

Hirst LW, Sebban A, Chant D. Pterygium recurrence time. Ophthalmology. 1994 Apr;101(4):755-8. doi: 10.1016/s0161-6420(94)31270-x.

Reference Type BACKGROUND
PMID: 8152771 (View on PubMed)

Ozer A, Yildirim N, Erol N, Yurdakul S. Long-term results of bare sclera, limbal-conjunctival autograft and amniotic membrane graft techniques in primary pterygium excisions. Ophthalmologica. 2009;223(4):269-73. doi: 10.1159/000210444. Epub 2009 Apr 2.

Reference Type BACKGROUND
PMID: 19339811 (View on PubMed)

Zheng K, Cai J, Jhanji V, Chen H. Comparison of pterygium recurrence rates after limbal conjunctival autograft transplantation and other techniques: meta-analysis. Cornea. 2012 Dec;31(12):1422-7. doi: 10.1097/ICO.0b013e31823cbecb.

Reference Type BACKGROUND
PMID: 22643650 (View on PubMed)

Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.

Reference Type BACKGROUND
PMID: 12686302 (View on PubMed)

Li M, Zhu M, Yu Y, Gong L, Zhao N, Robitaille MJ. Comparison of conjunctival autograft transplantation and amniotic membrane transplantation for pterygium: a meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2012 Mar;250(3):375-81. doi: 10.1007/s00417-011-1820-8. Epub 2011 Sep 21.

Reference Type BACKGROUND
PMID: 21935607 (View on PubMed)

Hirst LW. Recurrence and complications after 1,000 surgeries using pterygium extended removal followed by extended conjunctival transplant. Ophthalmology. 2012 Nov;119(11):2205-10. doi: 10.1016/j.ophtha.2012.06.021. Epub 2012 Aug 11.

Reference Type BACKGROUND
PMID: 22892149 (View on PubMed)

Gris O, Guell JL, del Campo Z. Limbal-conjunctival autograft transplantation for the treatment of recurrent pterygium. Ophthalmology. 2000 Feb;107(2):270-3. doi: 10.1016/s0161-6420(99)00041-x.

Reference Type BACKGROUND
PMID: 10690823 (View on PubMed)

Other Identifiers

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20160816

Identifier Type: -

Identifier Source: org_study_id

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