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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shiyou Zhou, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01319721
First received: March 21, 2011
Last updated: March 5, 2015
Last verified: March 2015
  Purpose
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.

Condition Intervention
Recurrent Pterygium
Procedure: MMC
Procedure: LCAG
Procedure: AMG

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Limbal Conjunctival Autograft Versus Amniotic Membrane Graft When Combined With Mitomycin C for Recurrent Pterygium: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Recurrence [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Complications [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Healing Time of Corneal Epithelial Defect [ Time Frame: Four Weeks ] [ Designated as safety issue: No ]
  • Eye Movement Amplitude (EMA) [ Time Frame: One Year ] [ Designated as safety issue: No ]
  • Postoperative Conjunctival Inflammation [ Time Frame: One month ] [ Designated as safety issue: No ]
    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).


Enrollment: 96
Study Start Date: December 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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: 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
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01319721

Locations
China, Guangdong
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Shiyou Zhou
Investigators
Study Director: Shiyou Zhou, MD, PHD Zhongshan Ophthalmic Center, Sun Yat-sen University
  More Information

Responsible Party: Shiyou Zhou, M.D., Ph.D., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01319721     History of Changes
Other Study ID Numbers: 20101215 
Study First Received: March 21, 2011
Results First Received: March 4, 2015
Last Updated: March 5, 2015
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Amniotic membrane
Limbal conjunctival autograft
Limbal
Conjunctival
Mitomycin C
Recurrent pterygium
Pterygium

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 30, 2016