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Intraoperative Mitomycin C, Amniotic Membrane Transplantation and Conjunctival Autograft for Primary Pterygium

NCT ID: NCT02102776

Last Updated: 2015-12-17

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

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

Brief Summary

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The purpose of this randomized multi-center clinical trial is to compare the efficacy and safety of intraoperative mitomycin C(MMC),amniotic membrane transplantation(AMT) and Conjunctival Autograft(CAG) for primary pterygium surgery. The investigators will also evaluate particular risk factors related to pterygium recurrence.

Detailed Description

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Patients with primary pterygium will be randomly assigned to undertake pterygium excision followed by intraoperative mitomycin C application,amniotic membrane transplantation or conjunctival autograft in five clinical centers. Multi-center collaboration and quality monitoring will be based on a website designed for this study. The patients will be followed at least 12 months. Corneal Recurrence as the primary outcome measure, is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag.

Conditions

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Pterygium

Keywords

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Primary Pterygium Mitomycin C Amniotic membrane transplantation Conjunctival autograft Multi-center randomized clinical trial

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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MMC after pterygium excision

Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft.

Group Type ACTIVE_COMPARATOR

MMC

Intervention Type PROCEDURE

Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.

Pterygium excision

Intervention Type PROCEDURE

Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.

AMT after Pterygium Excision

Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied.

Group Type ACTIVE_COMPARATOR

AMT

Intervention Type PROCEDURE

Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.

Pterygium excision

Intervention Type PROCEDURE

Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.

CAG after Pterygium Excision

A conjunctival autograft will be harvested from the superior side of the operating eye's bulbar conjunctiva. Then the graft will be sutured to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied.

Group Type ACTIVE_COMPARATOR

CAG

Intervention Type PROCEDURE

A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.

Pterygium excision

Intervention Type PROCEDURE

Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.

Interventions

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MMC

Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.

Intervention Type PROCEDURE

AMT

Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.

Intervention Type PROCEDURE

CAG

A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.

Intervention Type PROCEDURE

Pterygium excision

Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.

Intervention Type PROCEDURE

Other Intervention Names

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Intraoperative mitomycin C Amniotic membrane transplantation Conjunctival autograft

Eligibility Criteria

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Inclusion Criteria

* Primary pterygium
* Willingness to participate in research project and to attend research follow-up
* Adults (age 18 to 80 years old)

Exclusion Criteria

* Pregnant,breast-feeding women or patients with poor general health
* Patients with significant ocular or lid pathology, such as Sjogren's Syndrome, infection, exposure keratitis, glaucoma, active uveitis, retinal detachment and trauma
* Patients with previous surgery on ocular surface, such as trabeculectomy, strabismus surgery
* Patients with allergy to intraoperative or postoperative drugs, such as 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

M.D., Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiyou Zhou, 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

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Xi'an Eye Hospital

Xi’an, Shanxi, China

Site Status RECRUITING

Sichuan Ganzi Autonomous Prefecture People's Hospital

Ganzi, Sichuan, China

Site Status RECRUITING

The Fourth Affiliated Hospital, Kunming Medical University

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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

Role: CONTACT

Phone: 86-02087331540

Email: [email protected]

Tao Zhou, M.D.

Role: CONTACT

Phone: 86-18126813938

Email: [email protected]

Facility Contacts

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

Role: primary

Lei Zhu, M.D, Ph.D.

Role: primary

zhanrong Li, M.D, Ph.D.

Role: backup

Haifeng Zhu, M.D., Ph.D.

Role: primary

Jing Yang, M.D.

Role: primary

Zhulin Hu, M.D., Ph.D.

Role: primary

Hai Liu, M.D.

Role: backup

Other Identifiers

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2014015

Identifier Type: -

Identifier Source: org_study_id