PterygiumNCT02102776
Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium
A study testing MMC, AMT and CAG in people with Pterygium, run by Sun Yat-sen University at 5 sites in China.
Trial summary
The purpose of this randomized multi-center clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and Conjunctival Autograft(CAG) for primary pterygium surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pterygium
- What is being tested?
- MMC, AMT and CAG
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 5 sitesChina
- Study dates
- Dec 2015to Dec 2017
- 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 pterygium
- Willingness to participate in research project and to attend research follow-up
- Adults (age 18 to 80 years old)
- Patients must not meet any of the following exclusion criteria
Who cannot join
- Pregnant,breast-feeding women or patients with poor general health
- Patients with significant ocular or lid pathology, such as Sjogren's Syndrome, infection, exposure keratitis, glaucoma, active uveitis, retinal detachment and trauma
- Patients with previous surgery on ocular surface, such as trabeculectomy, strabismus surgery
- Patients with allergy to intraoperative or postoperative drugs, such as mitomycin C, tobramycin or local anesthetics
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Sichuan Ganzi Autonomous Prefecture People's Hospital
Ganzi, Sichuan, 626000
Jing Yang, M.D., 86-13568690606, 1078812810@qq.com
Jing Yang, M.D.
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Shiyou Zhou, M.D., Ph.D., 86-02087331540, zhoushiy@mail.sysu.edu.cn
Shiyou Zhou, M.D., Ph.D.
- Recruiting
The Fourth Affiliated Hospital, Kunming Medical University
Kunming, Yunnan, 650000
Zhulin Hu, M.D., Ph.D., HZL77@263.net
Hai Liu, M.D., 86-13648845146, 2560940908@qq.com
- Recruiting
Xi'an Eye Hospital
Xi’an, Shanxi, 710000
Haifeng Zhu, M.D., Ph.D., 86-13709118376, ZHF200309@163.com
Haifeng Zhu, M.D., Ph.D.
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Lei Zhu, M.D, Ph.D., Hnyks135@126.com
zhanrong Li, M.D, Ph.D., 86-18838270992, 71203885@qq.com
About this study
Official title: Intraoperative Mitomycin C Application, Amniotic Membrane Transplantation and Conjunctival Autograft After Primary Pterygium Excision: A Multi-center Randomized Clinical Trial
The purpose of this randomized multi-center clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence.
Read the detailed description
Patients with primary pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C application,amniotic membrane transplantation or conjunctival autograft in five clinical centers. Multi-center collaboration and quality monitoring will be based on a website designed for this study. The patients will be followed at least 12 months. Corneal Recurrence as the primary outcome measure, is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag.
- Conditions
- Pterygium
- Being tested
- MMC, AMT, CAG, Pterygium excision
- Keywords
- Primary Pterygium, Mitomycin C, Amniotic membrane transplantation, Conjunctival autograft, Multi-center randomized clinical trial
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMCProcedure or surgery
Also called Intraoperative mitomycin C
Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
AMTProcedure or surgery
Also called Amniotic membrane transplantation
Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
CAGProcedure or surgery
Also called Conjunctival autograft
A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.
Pterygium excisionProcedure or surgery
Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
| Study group | Role | What they receive |
|---|---|---|
| MMC after pterygium excision | Active comparator | Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft. Receives: Procedure: MMC; Procedure: Pterygium excision |
| AMT after Pterygium Excision | Active comparator | Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied. Receives: Procedure: AMT; Procedure: Pterygium excision |
| CAG after Pterygium Excision | Active comparator | A conjunctival autograft will be harvested from the superior side of the operating eye's bulbar conjunctiva. Then the graft will be sutured to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied. Receives: Procedure: CAG; Procedure: Pterygium excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of pterygium
Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag
Measured: One year
Secondary outcomes (4)
Visual acuity
Measured: One year
Healing time of corneal epithelium
Measured: Four weeks
Healing time of conjunctival epithelium
Measured: Four weeks
Postoperative complications
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyou Zhou, Sun Yat-sen University
- Investigators
- Shiyou Zhou, M.D., Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102776
- Sponsor's protocol ID
- 2014015
- Status last verified
- Dec 2015
- First submitted
- 31 Mar 2014
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Mitomycin C Application, Amniotic Membrane Transplantation and Conjunctival Autograft After Primary Pterygium Excision: A Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02102776
- Acronym / sponsor ID
- 2014015
- Conditions
- Pterygium
- Keywords
- Primary Pterygium, Mitomycin C, Amniotic membrane transplantation, Conjunctival autograft, Multi-center randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Apr 2014 (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 randomized multi-center clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence.
Detailed description
Patients with primary pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C application,amniotic membrane transplantation or conjunctival autograft in five clinical centers. Multi-center collaboration and quality monitoring will be based on a website designed for this study. The patients will be followed at least 12 months. Corneal Recurrence as the primary outcome measure, is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MMC after pterygium excision | Active comparator | Procedure: MMC, Procedure: Pterygium excisionIntraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft. |
| AMT after Pterygium Excision | Active comparator | Procedure: AMT, Procedure: Pterygium excisionAmniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied. |
| CAG after Pterygium Excision | Active comparator | Procedure: CAG, Procedure: Pterygium excisionA conjunctival autograft will be harvested from the superior side of the operating eye's bulbar conjunctiva. Then the graft will be sutured to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary pterygium
- Willingness to participate in research project and to attend research follow-up
- Adults (age 18 to 80 years old)
- Patients must not meet any of the following exclusion criteria
Key exclusion criteria (4 listed)
- Pregnant,breast-feeding women or patients with poor general health
- Patients with significant ocular or lid pathology, such as Sjogren's Syndrome, infection, exposure keratitis, glaucoma, active uveitis, retinal detachment and trauma
- Patients with previous surgery on ocular surface, such as trabeculectomy, strabismus surgery
- Patients with allergy to intraoperative or postoperative drugs, such as mitomycin C, tobramycin or local anesthetics
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 |
|---|---|---|
| MMCAlso: Intraoperative mitomycin CStandardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision. | Procedure or surgery | MMC after pterygium excision |
| AMTAlso: Amniotic membrane transplantationAmniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. | Procedure or surgery | AMT after Pterygium Excision |
| CAGAlso: Conjunctival autograftA conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision. | Procedure or surgery | CAG after Pterygium Excision |
| Pterygium excisionPterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue. | Procedure or surgery | AMT after Pterygium Excision, CAG after Pterygium Excision, MMC after pterygium excision |
Primary outcome
Recurrence of pterygium
Time frame: One year
Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag
4 secondary outcomes
Visual acuity
Time frame: One year
Healing time of corneal epithelium
Time frame: Four weeks
Healing time of conjunctival epithelium
Time frame: Four weeks
Postoperative complications
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
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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.
Shiyou Zhou, M.D., Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMC, AMT and CAG in people with Pterygium, run by Sun Yat-sen University at 5 sites 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 4 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 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Shiyou Zhou, M.D., Ph.D. (86-02087331540, zhoushiy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of pterygium (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2015.