Evaluating the Role of Incision Height in Trichiasis Surgery Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,914
- 试验地点
- 1
- 主要终点
- Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months
研究概览
简要总结
The purpose of this study is to determine whether the rate of post-operative trachomatous trichiasis differs significantly between bilamellar tarsal rotation surgery with an incision height of 3 mm, bilamellar tarsal rotation surgery with an incision height of 5 mm, and Trabut surgery.
详细描述
In this trial the investigators will randomize 4,953 individuals with previously unoperated trichiasis on a 1:1:1 basis to bilamellar tarsal rotation trichiasis surgery with an incision height of 3 mm, bilamellar tarsal rotation trichiasis surgery with an incision height of 5 mm, or Trabut surgery. Participants will receive trichiasis surgery then will be followed at 1 day, 2 weeks, 6 weeks, and 12 months after surgery. Some participants may be asked to attend a follow-up visit at 3-6 months. The primary outcome is development of post-operative trachomatous trichiasis (PTT) within 12 months after surgery. Logistic regression analyses will be performed to compare the rates of PTT in the 3 versus 5 mm incision bilamellar tarsal rotation (BLTR) groups, in the 3 mm BLTR versus Trabut group, and in the 5 mm BLTR versus Trabut group, adjusting for demographic characteristics and pre-operative trichiasis severity.
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
- Double (Participant, 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
- •At least one eyelid with previously unoperated upper eyelid trichiasis
- •Willing to comply with all study procedures and be available for the duration of the study
排除标准
- •Inability to provide independent, informed consent
- •All eyes with previously unoperated trichiasis are phthisical
结局指标
主要结局
Number of Eyes With Presence of Post-Operative Trichiasis Within 12 Months
时间窗: 12 Months
Presence of post-operative trichiasis is defined as 1+ trichiatic eyelashes or evidence of recent epilation. Any eyelashes touching the eye with the eye in primary gaze are considered to be trichiatic. Outcomes will be evaluated at 6 weeks and 12 months. The first date of post-operative trichiasis will be used as the outcome.
次要结局
- Number of Eyes With Presence of Post-Operative Trichiasis at 6 Weeks(6 Weeks)
- Severity of Post-Operative Trichiasis at 6 Weeks(6 Weeks)
- Severity of Post-Operative Trichiasis at 12 Months(12 Months)
- Number of Eyes With Presence of Eyelid Contour Abnormalities Within 12 Months(12 Months)
- Severity of Eyelid Contour Abnormalities at 6 Weeks(6 Weeks)
- Number of Eyes With Changes in Eyelid Contour Abnormalities Between 6 Weeks and 1 Year(12 months)
- Severity of Eyelid Contour Abnormalities at 12 Months(12 Months)
- Number of Eyes With Presence of Eyelid Contour Abnormalities at 6 Weeks(6 Weeks)
- Number of Eyes With Presence of Post-Operative Trichiasis Within 3 Years(up to 3 Years)
- Number of Eyes With Presence of Pyogenic Granuloma at 6 Weeks(6 weeks)
- Number of Eyes With Presence of Pyogenic Granulomas Within 12 Months(up to 12 Months)