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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: MMC
Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
Other Names:
  • Intraoperative mitomycin C
Procedure: Pterygium excision
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.
Procedure: Pterygium excision
Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
Procedure: AMT
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.
Procedure: Pterygium excision
Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
Procedure: CAG
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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