Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane

March 5, 2015 updated by: Shiyou Zhou

Limbal Conjunctival Autograft Versus Amniotic Membrane Graft When Combined With Mitomycin C for Recurrent Pterygium: A Randomized Trial

To compare the outcomes of limbal conjunctival autograft (LCAG) versus amniotic membrane graft (AMG) when combined with intraoperative 0.02% mitomycin C (MMC) after pterygium removal in patients with recurrent pterygium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Excision alone for treating recurrent pterygium was reported to be at risk of high recurrence again. As one of adjunctive methods, intraoperative application of a single dose of mitomycin C (MMC) seems to be the most commonly used method for preventing recurrence of pterygium. Additionally, closure of conjunctival defect after excision of pterygium by limbal conjunctival autograft or amniotic membrane have also become popular in recent years. There are a few reports in which MMC combined either limbal conjunctival autograft (LCAG) or amniotic membrane graft (AMG) for the treatment of recurrent pterygium. To assess the effectiveness and safety of these two combined approaches, the investigator plans to work on a randomized comparative and prospective trial of recurrent pterygium extensive excision with intraoperative 0.02% MMC application comparing LCAG to AMG.The patients enrolled in this study will be followed for at least 12 months after the surgery. Recurrence was defined as fibrovascular tissue crossing the limbus on to the clear cornea in the area of previous pterygium excision.

Study Type

Interventional

Enrollment (Actual)

96

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
        • State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

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:

  • The patients had one or two eye(s) with unilateral recurrent pterygium.
  • Recurrent pterygium：be defined as of fibrovascular tissue onto the cornea for any distance in the position of a previous pterygium.
  • Willingness to participate in research project and to attend research time.

Exclusion Criteria:

  • Poor general health.
  • Pregnant or lactating women.
  • Patients with collagen vascular diseases or other autoimmune diseases.
  • Patients with any evidence of stem cell deficiency.
  • Patients with glaucoma who might require future filtering surgery.
  • Patients with ocular infection.
  • Patients with an allergy to mitomycin C, tobramycin or dexamethasone.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group LCAG
After extensive excision of recurrent pterygium, intraoperative 0.2 mg/ml MMC (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
Procedure: MMC
Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after extensive excision of recurrent pterygium.
Other Names:
  • mitomycin C
Procedure: AMG
Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
Other Names:
  • amniotic membrane graft
  • amniotic membrane transplantation
  • amniotic membrane graft transplantation
Active Comparator: Group AMG
After excision of recurrent pterygium, intraoperative 0.2 mg/ml MMC (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
Procedure: AMG
Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
Other Names:
  • amniotic membrane graft
  • amniotic membrane transplantation
  • amniotic membrane graft transplantation
Procedure: LCAG
Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
Other Names:
  • limbal conjunctiva
  • limbal conjunctival autograft
  • limbal conjunctival autograft transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: One Year
Recurrence was defined as the presence of fibrovascular tissue in the surgical area and invasion onto the cornea. The appearance of the surgical bed in successful cases was graded as follows: grade A was defined as the operated eye being indistinguishable from a normal eye, grade B was defined as the presence of fine episcleral vessels without fibrous tissue in the surgical area extending up to the limbus but not beyond, and grade C was defined as the presence of fibrovascular tissue in the surgical area but without invasion onto the cornea.
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: One year
One year
Healing Time of Corneal Epithelial Defect
Time Frame: Four Weeks
Four Weeks
Eye Movement Amplitude (EMA)
Time Frame: One Year
One Year
Postoperative Conjunctival Inflammation
Time Frame: One month
The presence of conjunctival inflammation around the surgical site was assessed at 4 weeks post-operatively and graded as 0 (none), i (mild), ii (moderate), and iii (severe).
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiyou Zhou

Investigators

  • Study Director: Shiyou Zhou, MD, PHD, 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, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 21, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101215

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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