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临床试验/NCT01024257
NCT01024257已完成3 期

Pterygium Treatment Using Single Beta-therapy as Adjuvant Treatment Compared to Conjunctival Autograft

Marilia Medicine School1 个研究点 分布在 1 个国家开始时间: 2009年12月2日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
试验地点
1

研究概览

简要总结

PURPOSE: To affirm the effectiveness and complication rate of postoperative single-dose beta-irradiation (RT) with (90) Sr in the case of primary pterygium in a clinical trial. METHODS AND MATERIALS: This trial was designed as a prospective, randomized, single center study. Surgery was performed in all cases according to the conjunctival autograft technique. One thousand and four patients with 108 pterygia were postoperatively randomized to either beta-RT or observation. In the case of beta-RT, a (90) Sr eye applicator was used to deliver 1000 cGy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. RESULTS: Between February 2007 and September 2008, 104 eyes with primary pterygium were operated on according to the trial protocol. Additional treatment was performed within 24 hours postoperatively. Four patients were lost to follow-up, resulting in 104 patients who could be analyzed. In the 54 eyes randomized to receive beta-RT, 5 relapses occurred compared with 8 recurrences in the 50 eyes that no received RT, for a crude control rate of 90.7 % vs. 84 %, respectively. At a mean follow-up of 9 months (range 4- 18), major treatment complications had not been observed . CONCLUSION: Single-dose beta-RT of 1000cGy after conjunctival autograft surgery is a simple, effective, and safe treatment that reduces the risk of primary pterygium recurrence.

研究设计

研究类型
Interventional

入排标准

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

入选标准

  • •Fresh pterygium without previous treatment.
  • •Adult patients with age higher than 18 years.

排除标准

  • •Diagnosis of glaucoma.
  • •Previous treatment of pterygium.
  • •Patients with age less than 18 years old.

研究组 & 干预措施

conjunctival autograft

Active Comparator

干预措施: conjunctival autograft (Procedure)

conjunctival autograft plus beta-irradiation

Experimental

干预措施: beta-irradiation (Radiation)

研究者

发起方
Marilia Medicine School
申办方类型
Other

研究点 (1)

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