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

Sun Yat-sen University

Status: Unknown

Conditions: Pterygium

Treatments: Procedure: Pterygium excision; Procedure: CAG; Procedure: AMT; Procedure: MMC

Study type: Interventional

Funder types: Other

Identifiers

NCT02102776

2014015

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary pterygium
• Willingness to participate in research project and to attend research follow-up
• Adults (age 18 to 80 years old)
• Patients must not meet any of the following exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 3 patient groups

MMC after pterygium excision

Active Comparator group

Description:

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

Treatment:

Procedure: MMC

Procedure: Pterygium excision

AMT after Pterygium Excision

Active Comparator group

Description:

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

Treatment:

Procedure: AMT

Procedure: Pterygium excision

CAG after Pterygium Excision

Active Comparator group

Description:

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.

Treatment:

Procedure: Pterygium excision

Procedure: CAG