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临床试验/NCT01686529
NCT01686529已完成1 期

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

Instituto de Oftalmología Fundación Conde de Valenciana1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
Pterygium recurrence

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary pterygium

排除标准

  • Patients with diabetes mellitus
  • collagenopathies,
  • previous ocular surgeries,
  • pregnant or lactating patients

研究组 & 干预措施

One subconjunctival injection

Experimental

Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery

干预措施: Autoconjunctival grafting (Procedure)

One subconjunctival injection

Experimental

Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery

干预措施: Subconjuntival bevacizumab injection (Drug)

Two subconjuctival injections

Experimental

Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery

干预措施: Autoconjunctival grafting (Procedure)

Two subconjuctival injections

Experimental

Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery

干预措施: Subconjuntival bevacizumab injection (Drug)

Conventional treatment

Active Comparator

Autoconjunctival grafting without subconjuntival bevacizumab injection

干预措施: Autoconjunctival grafting (Procedure)

结局指标

主要结局

Pterygium recurrence

时间窗: One point.

The pterygium recurrence is evaluated at one year postoperative

次要结局

  • Conjunctival ischemia(Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative)

研究者

发起方
Instituto de Oftalmología Fundación Conde de Valenciana
申办方类型
Other
责任方
Sponsor

研究点 (1)

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