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

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

Study Contact Backup

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • 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:
        • 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:
        • Principal Investigator:
          • Haifeng Zhu, M.D., Ph.D.
    • Sichuan
      • Ganzi, Sichuan, China, 626000
        • Recruiting
        • Sichuan Ganzi Autonomous Prefecture People's Hospital
        • Contact:
        • Principal Investigator:
          • Jing Yang, M.D.
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Recruiting
        • The Fourth Affiliated Hospital, Kunming Medical University
        • Contact:
        • Contact:
        • 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:
  • Intraoperative mitomycin C
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:
  • Amniotic membrane transplantation
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:
  • Conjunctival autograft

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.

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

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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