Study Results
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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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2010-03-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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One subconjunctival injection
Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery
Autoconjunctival grafting
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.
Subconjuntival bevacizumab injection
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.
Two subconjuctival injections
Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery
Autoconjunctival grafting
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.
Subconjuntival bevacizumab injection
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.
Conventional treatment
Autoconjunctival grafting without subconjuntival bevacizumab injection
Autoconjunctival grafting
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.
Interventions
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Autoconjunctival grafting
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.
Subconjuntival bevacizumab injection
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* collagenopathies,
* previous ocular surgeries,
* pregnant or lactating patients
18 Years
70 Years
ALL
No
Sponsors
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Instituto de Oftalmología Fundación Conde de Valenciana
OTHER
Responsible Party
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Principal Investigators
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Yonathan Garfias, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Oftalmología
Locations
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Instituto de Oftalmología
Mexico City, Mexico City, Mexico
Countries
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References
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Nava-Castaneda A, Olvera-Morales O, Ramos-Castellon C, Garnica-Hayashi L, Garfias Y. Randomized, controlled trial of conjunctival autografting combined with subconjunctival bevacizumab for primary pterygium treatment: 1-year follow-up. Clin Exp Ophthalmol. 2014 Apr;42(3):235-41. doi: 10.1111/ceo.12140. Epub 2013 Jul 5.
Related Links
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This is the link to the reference published on Pubmed
Other Identifiers
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CC-008-2010
Identifier Type: -
Identifier Source: org_study_id