- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02102776
Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium
December 16, 2015 updated by: Shiyou Zhou, Sun Yat-sen University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
750
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shiyou Zhou, M.D., Ph.D.
- Phone Number: 86-02087331540
- Email: zhoushiy@mail.sysu.edu.cn
Study Contact Backup
- Name: Tao Zhou, M.D.
- Phone Number: 86-18126813938
- Email: taochou_tony@foxmail.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Zhongshan Ophthalmic Center, Sun Yat-sen University
-
Contact:
- Shiyou Zhou, M.D., Ph.D.
- Phone Number: 86-02087331540
- Email: zhoushiy@mail.sysu.edu.cn
-
Principal Investigator:
- Shiyou Zhou, M.D., Ph.D.
-
Sub-Investigator:
- Tao Zhou, M.D.
-
-
Henan
-
Zhengzhou, Henan, China, 450003
- Recruiting
- Henan Provincial People's Hospital
-
Contact:
- Lei Zhu, M.D, Ph.D.
- Email: Hnyks135@126.com
-
Contact:
- zhanrong Li, M.D, Ph.D.
- Phone Number: 86-18838270992
- Email: 71203885@qq.com
-
Principal Investigator:
- Lei Zhu, M.D, Ph.D.
-
Sub-Investigator:
- Zhanrong Li, M.D, Ph.D.
-
-
Shanxi
-
Xi'an, Shanxi, China, 710000
- Recruiting
- Xi'an Eye Hospital
-
Contact:
- Haifeng Zhu, M.D., Ph.D.
- Phone Number: 86-13709118376
- Email: ZHF200309@163.com
-
Principal Investigator:
- Haifeng Zhu, M.D., Ph.D.
-
-
Sichuan
-
Ganzi, Sichuan, China, 626000
- Recruiting
- Sichuan Ganzi Autonomous Prefecture People's Hospital
-
Contact:
- Jing Yang, M.D.
- Phone Number: 86-13568690606
- Email: 1078812810@qq.com
-
Principal Investigator:
- Jing Yang, M.D.
-
-
Yunnan
-
Kunming, Yunnan, China, 650000
- Recruiting
- The Fourth Affiliated Hospital, Kunming Medical University
-
Contact:
- Zhulin Hu, M.D., Ph.D.
- Email: HZL77@263.net
-
Contact:
- Hai Liu, M.D.
- Phone Number: 86-13648845146
- Email: 2560940908@qq.com
-
Principal Investigator:
- Zhulin Hu, M.D., Ph.D.
-
Sub-Investigator:
- Hai Liu, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: MMC after pterygium excision
Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.
The conjunctival defect will be left bare without graft.
|
Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
Other Names:
Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
|
Active Comparator: AMT after Pterygium Excision
Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
No mitomycin C will be applied.
|
Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
Other Names:
|
Active Comparator: CAG after Pterygium Excision
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.
|
Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of pterygium
Time Frame: One year
|
Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual acuity
Time Frame: One year
|
One year
|
Healing time of corneal epithelium
Time Frame: Four weeks
|
Four weeks
|
Healing time of conjunctival epithelium
Time Frame: Four weeks
|
Four weeks
|
Postoperative complications
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shiyou Zhou, M.D., Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
March 31, 2014
First Submitted That Met QC Criteria
March 31, 2014
First Posted (Estimate)
April 3, 2014
Study Record Updates
Last Update Posted (Estimate)
December 17, 2015
Last Update Submitted That Met QC Criteria
December 16, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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