search
Back to results

Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium

Primary Purpose

Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MMC
AMT
CAG
Pterygium excision
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring Primary Pterygium, Mitomycin C, Amniotic membrane transplantation, Conjunctival autograft, Multi-center randomized clinical trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
  • Henan Provincial People's HospitalRecruiting
  • Xi'an Eye HospitalRecruiting
  • Sichuan Ganzi Autonomous Prefecture People's HospitalRecruiting
  • The Fourth Affiliated Hospital, Kunming Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

MMC after pterygium excision

AMT after Pterygium Excision

CAG after Pterygium Excision

Arm Description

Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft.

Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied.

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.

Outcomes

Primary Outcome Measures

Recurrence of pterygium
Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag

Secondary Outcome Measures

Visual acuity
Healing time of corneal epithelium
Healing time of conjunctival epithelium
Postoperative complications

Full Information

First Posted
March 31, 2014
Last Updated
December 16, 2015
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT02102776
Brief Title
Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium
Official Title
Intraoperative Mitomycin C Application, Amniotic Membrane Transplantation and Conjunctival Autograft After Primary Pterygium Excision: A Multi-center Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
Primary Pterygium, Mitomycin C, Amniotic membrane transplantation, Conjunctival autograft, Multi-center randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MMC after pterygium excision
Arm Type
Active Comparator
Arm Description
Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft.
Arm Title
AMT after Pterygium Excision
Arm Type
Active Comparator
Arm Description
Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied.
Arm Title
CAG after Pterygium Excision
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
MMC
Other Intervention Name(s)
Intraoperative mitomycin C
Intervention Description
Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
Intervention Type
Procedure
Intervention Name(s)
AMT
Other Intervention Name(s)
Amniotic membrane transplantation
Intervention Description
Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
Intervention Type
Procedure
Intervention Name(s)
CAG
Other Intervention Name(s)
Conjunctival autograft
Intervention Description
A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.
Intervention Type
Procedure
Intervention Name(s)
Pterygium excision
Intervention Description
Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
Primary Outcome Measure Information:
Title
Recurrence of pterygium
Description
Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag
Time Frame
One year
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
One year
Title
Healing time of corneal epithelium
Time Frame
Four weeks
Title
Healing time of conjunctival epithelium
Time Frame
Four weeks
Title
Postoperative complications
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyou Zhou, M.D., Ph.D.
Phone
86-02087331540
Email
zhoushiy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Zhou, M.D.
Phone
86-18126813938
Email
taochou_tony@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyou Zhou, M.D., Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyou Zhou, M.D., Ph.D.
Phone
86-02087331540
Email
zhoushiy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Shiyou Zhou, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Tao Zhou, M.D.
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhu, M.D, Ph.D.
Email
Hnyks135@126.com
First Name & Middle Initial & Last Name & Degree
zhanrong Li, M.D, Ph.D.
Phone
86-18838270992
Email
71203885@qq.com
First Name & Middle Initial & Last Name & Degree
Lei Zhu, M.D, Ph.D.
First Name & Middle Initial & Last Name & Degree
Zhanrong Li, M.D, Ph.D.
Facility Name
Xi'an Eye Hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haifeng Zhu, M.D., Ph.D.
Phone
86-13709118376
Email
ZHF200309@163.com
First Name & Middle Initial & Last Name & Degree
Haifeng Zhu, M.D., Ph.D.
Facility Name
Sichuan Ganzi Autonomous Prefecture People's Hospital
City
Ganzi
State/Province
Sichuan
ZIP/Postal Code
626000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Yang, M.D.
Phone
86-13568690606
Email
1078812810@qq.com
First Name & Middle Initial & Last Name & Degree
Jing Yang, M.D.
Facility Name
The Fourth Affiliated Hospital, Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhulin Hu, M.D., Ph.D.
Email
HZL77@263.net
First Name & Middle Initial & Last Name & Degree
Hai Liu, M.D.
Phone
86-13648845146
Email
2560940908@qq.com
First Name & Middle Initial & Last Name & Degree
Zhulin Hu, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Hai Liu, M.D.

12. IPD Sharing Statement

Learn more about this trial

Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium

We'll reach out to this number within 24 hrs