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

Primary Purpose

Recurrent Pterygium

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MMC
LCAG
AMG
Sponsored by
Shiyou Zhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Pterygium focused on measuring Amniotic membrane, Limbal conjunctival autograft, Limbal, Conjunctival, Mitomycin C, Recurrent pterygium, Pterygium

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group LCAG

Group AMG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recurrence
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
Healing Time of Corneal Epithelial Defect
Eye Movement Amplitude (EMA)
Postoperative Conjunctival Inflammation
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).

Full Information

First Posted
March 21, 2011
Last Updated
March 5, 2015
Sponsor
Shiyou Zhou
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1. Study Identification

Unique Protocol Identification Number
NCT01319721
Brief Title
Recurrent Pterygium Surgery Using Mitomycin C With Limbal Conjunctival or Amniotic Membrane
Official Title
Limbal Conjunctival Autograft Versus Amniotic Membrane Graft When Combined With Mitomycin C for Recurrent Pterygium: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shiyou Zhou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pterygium
Keywords
Amniotic membrane, Limbal conjunctival autograft, Limbal, Conjunctival, Mitomycin C, Recurrent pterygium, Pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group LCAG
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group AMG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
MMC
Other Intervention Name(s)
mitomycin C
Intervention Description
Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after extensive excision of recurrent pterygium.
Intervention Type
Procedure
Intervention Name(s)
LCAG
Other Intervention Name(s)
limbal conjunctiva, limbal conjunctival autograft, limbal conjunctival autograft transplantation
Intervention Description
Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
Intervention Type
Procedure
Intervention Name(s)
AMG
Other Intervention Name(s)
amniotic membrane graft, amniotic membrane transplantation, amniotic membrane graft transplantation
Intervention Description
Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
Primary Outcome Measure Information:
Title
Recurrence
Description
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.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Complications
Time Frame
One year
Title
Healing Time of Corneal Epithelial Defect
Time Frame
Four Weeks
Title
Eye Movement Amplitude (EMA)
Time Frame
One Year
Title
Postoperative Conjunctival Inflammation
Description
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).
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyou Zhou, MD, PHD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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

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