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

NCT ID: NCT04463901

Last Updated: 2020-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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Recurrent Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Pterygium excision

Intervention Type PROCEDURE

Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.

Intraoperative mitomycin C

Intervention Type PROCEDURE

Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.

Conjunctival autograft

Intervention Type PROCEDURE

A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.

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.

Group Type ACTIVE_COMPARATOR

Pterygium excision

Intervention Type PROCEDURE

Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.

Intraoperative mitomycin C

Intervention Type PROCEDURE

Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.

Limbal conjunctival autograft

Intervention Type PROCEDURE

A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.

Interventions

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Pterygium excision

Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.

Intervention Type PROCEDURE

Intraoperative mitomycin C

Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.

Intervention Type PROCEDURE

Conjunctival autograft

A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.

Intervention Type PROCEDURE

Limbal conjunctival autograft

A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.

Intervention Type PROCEDURE

Other Intervention Names

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MMC CAG LCAG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Shiyou Zhou

MD,PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhou Shiyou, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhou Shiyou, M.D., Ph.D.

Role: CONTACT

86-02087331540

Zhou Tao, M.D.

Role: CONTACT

86-18126813938

Facility Contacts

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Shiyou Zhou, M.D., Ph.D.

Role: primary

86-02087331550

Other Identifiers

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20150527

Identifier Type: -

Identifier Source: org_study_id

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