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

Primary Purpose

Recurrent Pterygium

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pterygium excision
Intraoperative mitomycin C
Conjunctival autograft
Limbal conjunctival autograft
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Pterygium focused on measuring recurrent pterygium, pterygium, limbal conjunctival autograft, conjunctival autograft, mitomycin c

Eligibility Criteria

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

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

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group CAG

Group LCAG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recurrence of pterygium

Secondary Outcome Measures

Visual acuity
Healing time of corneal epithelium
Healing time of conjunctival epithelium
Postoperative complications

Full Information

First Posted
July 4, 2020
Last Updated
July 4, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04463901
Brief Title
Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium Using Mitomycin C
Official Title
Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pterygium
Keywords
recurrent pterygium, pterygium, limbal conjunctival autograft, conjunctival autograft, mitomycin c

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group CAG
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group LCAG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pterygium excision
Intervention Description
Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative mitomycin C
Other Intervention Name(s)
MMC
Intervention Description
Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.
Intervention Type
Procedure
Intervention Name(s)
Conjunctival autograft
Other Intervention Name(s)
CAG
Intervention Description
A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
Intervention Type
Procedure
Intervention Name(s)
Limbal conjunctival autograft
Other Intervention Name(s)
LCAG
Intervention Description
A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
Primary Outcome Measure Information:
Title
Recurrence of pterygium
Time Frame
One year
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
One year
Title
Healing time of corneal epithelium
Time Frame
Four weeks
Title
Healing time of conjunctival epithelium
Time Frame
Four weeks
Title
Postoperative complications
Time Frame
One year

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Shiyou, M.D., Ph.D.
Phone
86-02087331540
Email
zhoushiy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Tao, M.D.
Phone
86-18126813938
Email
taochou_tony@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhou Shiyou, M.D., Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyou Zhou, M.D., Ph.D.
Phone
86-02087331550
Email
zhoushiy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Tao Zhou, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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