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

Study Overview
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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.

Official Title
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Intraoperative Mitomycin C Application, Amniotic Membrane Transplantation and Conjunctival Autograft After Primary Pterygium Excision: A Multi-center Randomized Clinical Trial

Conditions
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Pterygium

Intervention / Treatment
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* Procedure: MMC
* Procedure: AMT
* Procedure: CAG
* Procedure: Pterygium excision


Participation Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MMC after pterygium excision<br>Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision. The conjunctival defect will be left bare without graft. | Procedure: MMC<br>* Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.<br>* Other names: Intraoperative mitomycin C;Procedure: Pterygium excision<br>* Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.<br>|
| Active Comparator: AMT after Pterygium Excision<br>Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision. No mitomycin C will be applied. | Procedure: AMT<br>* Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.<br>* Other names: Amniotic membrane transplantation;Procedure: Pterygium excision<br>* Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.<br>|
| Active Comparator: CAG after Pterygium Excision<br>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. | Procedure: CAG<br>* A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.<br>* Other names: Conjunctival autograft;Procedure: Pterygium excision<br>* Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of pterygium | Corneal Recurrence is considered as a fibrovascular ingrowth beyond the limbus with conjunctival drag | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | One year | 
| Healing time of corneal epithelium |  | Four weeks | 
| Healing time of conjunctival epithelium |  | Four weeks | 
| Postoperative complications |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Pterygium, Mitomycin C, Amniotic membrane transplantation, Conjunctival autograft, Multi-center randomized clinical trial