Bevacizumab for Primary Pterygium Treatment

Study Overview
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Brief Summary
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The aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.

Official Title
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Conjunctival Autografting Alone or Combined With Subconjunctival Bevacizumab for Primary Pterygium Treatment.

Conditions
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Pterygium

Intervention / Treatment
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* Procedure: Autoconjunctival grafting
* Drug: Subconjuntival bevacizumab injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary pterygium Exclusion Criteria: Patients with diabetes mellitus collagenopathies, previous ocular surgeries, pregnant or lactating patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One subconjunctival injection<br>Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery | Procedure: Autoconjunctival grafting<br>* The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.<br>Drug: Subconjuntival bevacizumab injection<br>* The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.<br>* Other names: Avastin;|
| Experimental: Two subconjuctival injections<br>Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery | Procedure: Autoconjunctival grafting<br>* The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.<br>Drug: Subconjuntival bevacizumab injection<br>* The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.<br>* Other names: Avastin;|
| Active Comparator: Conventional treatment<br>Autoconjunctival grafting without subconjuntival bevacizumab injection | Procedure: Autoconjunctival grafting<br>* The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pterygium recurrence | The pterygium recurrence is evaluated at one year postoperative | One point. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival ischemia | Whiteness of conjunctival bed, that means absence of blood vessels | Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pterygium, bevacizumab, autoconjunctival graft