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

Study Overview
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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.

Official Title
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Intraoperative Mitomycin C Combined With Conjunctival Autograft or Limbal Conjunctival Autograft for Recurrent Pterygium: a Randomized Clinical Trial

Conditions
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Recurrent Pterygium

Intervention / Treatment
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* Procedure: Pterygium excision
* Procedure: Intraoperative mitomycin C
* Procedure: Conjunctival autograft
* Procedure: Limbal conjunctival autograft


Participation Criteria
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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

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: Group CAG<br>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. | Procedure: Pterygium excision<br>* Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.<br>Procedure: Intraoperative mitomycin C<br>* Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.<br>* Other names: MMC;Procedure: Conjunctival autograft<br>* A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.<br>* Other names: CAG;|
| Active Comparator: Group LCAG<br>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. | Procedure: Pterygium excision<br>* Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.<br>Procedure: Intraoperative mitomycin C<br>* Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.<br>* Other names: MMC;Procedure: Limbal conjunctival autograft<br>* A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.<br>* Other names: LCAG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of pterygium |  | 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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recurrent pterygium, pterygium, limbal conjunctival autograft, conjunctival autograft, mitomycin c