PterygiumTECTPANCT02911532
Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia
A study testing Tissue engineering conjunctiva transplantation in people with Pterygium, run by Shandong Eye Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pterygium
- What is being tested?
- Tissue engineering conjunctiva transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2016to 1 Apr 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary and recurrent pterygium patients,atretoblepharia patients
- Voluntarily signed informed consent
- No surgery and anesthesia contraindications.
Who cannot join
- The patients combined systemic diseases
- Reject study and follow visit
- Patients don't accept the tissue engineering conjunctiva
- Cannot tolerate surgery or anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Eye Hospital
Jinan, Shandong, 250000
Suxia Li, 15854107085, ykyykjk@163.com
About this study
Official title: Tissue Engineering Conjunctiva Transplantation and Conjunctival Sac Formation for the Treatment of Pterygium and Atretoblepharia
The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.
Read the detailed description
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
- Pterygium
- Being tested
- Tissue engineering conjunctiva transplantation
- Keywords
- pterygium, tissue engineering, atretoblepharia
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue engineering conjunctiva transplantationProcedure or surgery
During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position
| Study group | Role | What they receive |
|---|---|---|
| Optical Coherence tomography | Experimental | Not described Receives: Procedure: Tissue engineering conjunctiva transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The epithelial defect size of the transplanted tissue engineering conjunctiva
Measured: the 7 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start1 Oct 2016
- Primary completion1 Oct 2017 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for PterygiumStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weiyun Shi, sponsor, Study chair, director of shandong eye hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911532
- Sponsor's protocol ID
- 20160816
- Acronym
- TECTPA
- Status last verified
- Aug 2017
- First submitted
- 26 Aug 2016
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23594771Mahar 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.
PubMed 23775605Farid 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.
PubMed 19092404Kaufman 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.
PubMed 23062647Tan 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.
PubMed 9338666Sandra 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.
PubMed 23733279Hirst LW, Sebban A, Chant D. Pterygium recurrence time. Ophthalmology. 1994 Apr;101(4):755-8. doi: 10.1016/s0161-6420(94)31270-x.
PubMed 8152771Ozer 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.
PubMed 19339811Zheng 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.
PubMed 22643650Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.
PubMed 12686302Li 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.
PubMed 21935607Hirst 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.
PubMed 22892149Gris 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.
PubMed 10690823
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Engineering Conjunctiva Transplantation and Conjunctival Sac Formation for the Treatment of Pterygium and Atretoblepharia
- ClinicalTrials.gov ID
- NCT02911532
- Acronym / sponsor ID
- TECTPA / 20160816
- Conditions
- Pterygium
- Keywords
- pterygium, tissue engineering, atretoblepharia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shandong Eye HospitalUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 22 Sep 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.
The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Coherence tomography | Experimental | Procedure: Tissue engineering conjunctiva transplantation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary and recurrent pterygium patients,atretoblepharia patients
- Voluntarily signed informed consent
- No surgery and anesthesia contraindications.
Key exclusion criteria (4 listed)
- The patients combined systemic diseases
- Reject study and follow visit
- Patients don't accept the tissue engineering conjunctiva
- Cannot tolerate surgery or anesthesia
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 |
|---|---|---|
| Tissue engineering conjunctiva transplantationDuring the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position | Procedure or surgery | Optical Coherence tomography |
Primary outcome
The epithelial defect size of the transplanted tissue engineering conjunctiva
Time frame: the 7 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Background: PubMed 23594771Varssano 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.
- Background: PubMed 23775605Mahar 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.
- Background: PubMed 19092404Farid 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.
- Background: PubMed 23062647Kaufman 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.
- Background: PubMed 9338666Tan 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.
- Background: PubMed 23733279Sandra 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.
- Background: PubMed 8152771Hirst LW, Sebban A, Chant D. Pterygium recurrence time. Ophthalmology. 1994 Apr;101(4):755-8. doi: 10.1016/s0161-6420(94)31270-x.
- Background: PubMed 19339811Ozer 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.
- Background: PubMed 22643650Zheng 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.
- Background: PubMed 12686302Hirst LW. The treatment of pterygium. Surv Ophthalmol. 2003 Mar-Apr;48(2):145-80. doi: 10.1016/s0039-6257(02)00463-0.
- Background: PubMed 21935607Li 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.
- Background: PubMed 22892149Hirst 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.
- Individual participant dataSharing planned: Undecided
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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.
Weiyun Shi, sponsor study chair
director of shandong eye 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 Tissue engineering conjunctiva transplantation in people with Pterygium, run by Shandong Eye Hospital at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Aug 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suxia Li, researcher (8615854107085, ykyykjk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The epithelial defect size of the transplanted tissue engineering conjunctiva (time frame: the 7 days after operation). 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 NCT02911532, which also lists 13 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 16 Aug 2017.