Bevacizumab for Primary Pterygium Treatment

Conditions

• Pterygium

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Autoconjunctival grafting — PROCEDURE
  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 — DRUG
  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.

Study Details

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

Key Dates

First listed

Sep 18, 2012

Start date

Mar 31, 2010

Status verified

Dec 2013

Primary completion

Feb 28, 2011

Completion

Feb 29, 2012

Study Design

Enrollment

49 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Arms

• Experimental: One subconjunctival injection
  Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery
• Experimental: Two subconjuctival injections
  Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery
• Active Comparator: Conventional treatment
  Autoconjunctival grafting without subconjuntival bevacizumab injection

Primary Outcome Measure

Pterygium recurrence [ Time Frame: One point. ]