NCT01312545已完成不适用
Comparison of Exposure Rate Between Local Made and Imported Porous Polyethylene Orbital Implant for Enucleation in Thailand: A Randomized, Equivalence Controlled Trial and Multicenter Study
Mettapracharak Hospital2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Exposure rate
研究概览
简要总结
This study wants to compare between two types of implants in enucleation. Both of them are made from porous polyethylene but have different fabricating techniques. The investigators chose an exposure rate as a main outcome because the investigators think it is the most important outcome for the surgeons. The study hypothesis is: Is the exposure rate of a local-made polyethylene orbital implant the same as an imported one?
详细描述
Sample size assessment
- The sample size was calculated by using an equivalence formula. From a literature and our own experiences, the success rate for Medpor and 3DP were 92% and 94% respectively, the difference (D) of the success rate between two groups was 10% and assuming a 15% of drop out rate.
- Then allocation sequence was generated by a computerized program, using block of six with varying block size.
Data management
- All definition of data, recruiting techniques, data collection techniques and data management flow were mentioned in the SOP.
- After double entry technique, each case record form from each site will be sent via DataFax system to the data center at Center of Excellence for Biomedical and Public Health Informatics (BIOPHICS), Thailand.
- Then data will be validated, analyzed and reported by staff at BIOPHICS.
Plan for missing data
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Clinical diagnosis of phthisis bulbi, painful blindness, intraocular tumor without metastasis and severe ruptured eyeball
- •Must speak and understand Thai language well
- •Must have good consciousness
排除标准
- •Has a history of prior enucleation or evisceration
- •Cannot follow up for at least one year
- •Has recent eye infection within 6 months
结局指标
主要结局
Exposure rate
时间窗: From date of surgery until the date of first exposure, assessed up to 12 months
Exposure was defined as the separation of tissue over the anterior surface of an implant.
次要结局
- Infection rate(From date of surgery until the date of first infection, assessed up to 12 months)
研究者
Dr. Sunisa Sintuwong
Dr.
Mettapracharak Hospital
研究点 (2)
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