Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C

July 4, 2020 updated by: Shiyou Zhou, Sun Yat-sen University

Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial

The purpose of this randomized clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC) combined with limbal conjunctival autograft(LCAG) or conjunctival autograft(CAG) for recurrent pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Intraoperative mitomycin C after pterygium excision is widely used to prevent recurrce of recurrent pterygium. Conjunctival autograft with or without limbal tissue used to cover the bare sclera will efficiently reduce postoperative longstanding epithelial defect.

Patients with recurrent pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C with conjunctival autograft or limbal conjunctival autograft .The patients will be followed at least 12 months. Corneal recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag in the area of previous pterygium excision.

Study Type

Interventional

Enrollment (Anticipated)

116

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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Tao Zhou, 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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recurrent pterygium
  • Willingness to participate in research project and to attend research time
  • At least 6 months after last pterygium surgery

Exclusion Criteria:

  • Pregnant,breast-feeding women or poor general health
  • Patients with significant ocular or lid pathology, such as Sjogren's Syndrome ,infection, exposure keratitis,glaucoma and trauma
  • Patients with allergy to 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: Group CAG
After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then conjunctival autograft without limbal tissue will be used to cover the bare sclera.
Procedure: Pterygium excision
Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.
Procedure: Intraoperative mitomycin C
Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.
Other Names:
  • MMC
Procedure: Conjunctival autograft
A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
Other Names:
  • CAG
Active Comparator: Group LCAG
After pterygium excision, intraoperative mitomycin c (0.02%) for 5 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft will be used to cover the bare sclera.
Procedure: Pterygium excision
Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.
Procedure: Intraoperative mitomycin C
Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.
Other Names:
  • MMC
Procedure: Limbal conjunctival autograft
A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
Other Names:
  • LCAG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of pterygium
Time Frame: One year
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

Sun Yat-sen University

Investigators

  • Principal Investigator: Zhou Shiyou, 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

February 1, 2016

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

July 4, 2020

First Submitted That Met QC Criteria

July 4, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 4, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150527

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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