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Results of Adjunctive Intraoperative Bevacizumab Injection on Trabeculectomy Outcome

Phase 2
Completed
Conditions
Glaucoma
Interventions
Registration Number
NCT01263834
Lead Sponsor
Prince of Songkla University
Brief Summary

The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).

Detailed Description

Prospective interventional clinical trial

Single center, outcome assessor-masked, active control, randomized controlled trial

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
39
Inclusion Criteria
  • Primary open angle glaucoma with primary mmc-trabeculectomy indication
Exclusion Criteria
  • combined phacoemulsification with trabeculectomy
  • no more than 6 month of cataract surgery before trabeculectomy
  • revised trabeculectomy
  • active uveitic glaucoma
  • neovascular glaucoma
  • par planar vitrectomy
  • conjunctival surgery
  • allergy to bevacizumab or mitomycin C
  • ischemic heart disease
  • cerebrovascular disease
  • renal failure
  • liver failure

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mitomycin cMitomycin CMitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
BevacizumabBevacizumabBevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
Primary Outcome Measures
NameTimeMethod
Intraocular pressure6 month
Secondary Outcome Measures
NameTimeMethod
Bleb characteristic grading6 month
systemic Blood pressure6 months

Trial Locations

Locations (1)

Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University

🇹🇭

Hat-yai, Songkhla, Thailand

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