Partnership for the Rapid Elimination of Trachoma (PRET) Clinical Trial of Evaluation of Modified Instrumentation for Surgery to Correct Trichiasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,927
- 试验地点
- 2
- 主要终点
- Number of Eyelids With Presence of Recurrent Trichiasis
研究概览
简要总结
Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma which includes surgery to repair lids distorted by trachoma (trichiasis) in imminent danger of vision loss. Current evidence suggests that long-term success rates of trichiasis surgery are less than optimal due to variation in surgical technique. Previous research by this study team has demonstrated that shorter incisions have a higher rate of trichiasis recurrence. In addition, observations by this team's oculoplastic surgeon have led to the hypothesis that granuloma formation and lid contour abnormalities may result from current surgical practices. The objective of this study is to compare outcomes of trichiasis surgeries performed with the newly developed trachomatous trichiasis (TT) clamp versus surgeries following standard technique (bilamellar tarsal rotation procedure or BLTR).
详细描述
Field observations in 2005 by this study's PI and oculoplastic surgeon revealed some significant departures from current trichiasis surgery procedure (bilamellar tarsal rotation procedure or BTRP), as described in the WHO manual, "Trichiasis Surgery for Trachoma-the Bilamellar Tarsal Rotation Procedure". These procedural departures were felt to contribute to adverse outcomes, including trichiasis recurrence, granuloma formation and lid contour abnormalities. This study team developed a new surgical tool, the TT clamp, to help improve surgical outcomes following BLTR.
A randomized, single-masked clinical trial will be implemented in the Mtwara region in Tanzania. Study participants will be randomized on a 1:1 basis to surgery with the TT clamp or to surgery with standard BLTR equipment. All surgeries will take place at surgical centers in Mtwara and Lindi over an 8-month period.
Baseline assessment for severity of trichiasis and other predictors of surgical failure will be carried out prior to surgery. Follow-up is planned at 2 weeks (for suture removal), 6 weeks, 12 months, and 24 months post-surgery. At each follow-up visit participants will be assessed for evidence of unfavorable outcomes, including trichiasis recurrence, granuloma formation, and lid contour abnormalities. All outcomes will be assessed clinically by a trained observer who is masked to intervention status.
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
- Single (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
- •Presence of upper lid trichiasis: defined by at least one eyelash touching the globe of the eye or evidence of epilation
- •No previous report of trichiasis surgery in at least one eye with trichiasis:
- •eyes with prior surgery are already at high risk due to the prior surgery, and their inclusion may decrease our ability to clearly evaluate our primary outcome
- •if unilateral surgery has been performed previously, only the eye without prior history of surgery will be in the study, even if both eyes require surgery
- •Age 18 or older (in order to provide consent as an adult): the vast majority of trichiasis patients are aged 18 or older
- •At time of enrollment, subjects must state their intention to remain in the area for two years to facilitate study follow-up
排除标准
- •Absence of upper lid trichiasis
- •Prior trichiasis surgery on both eyes
- •Age 18 or younger
- •Subjects who are transiently in the area
结局指标
主要结局
Number of Eyelids With Presence of Recurrent Trichiasis
时间窗: 2 years
Trichiasis: 1 or more eyelashes touching globe in primary position
Number of Eyelids With Normal or Mild Eyelid Contour Abnormalities vs Moderate or Severe Eyelid Contour Abnormalities
时间窗: 2 years
Eyelid contour abnormalities (ECA) were graded by photographs of the eyes. In the primary outcome measure, normal eyes and mild eyelid contour abnormalities are considered together, and moderate or severe eyelid contour abnormalities are considered together. ECA severity is defined as follows: Mild: Vertical deviation from the natural contour \< 1 mm in height (less than half the pupil height in daylight) and affecting \< 1/3 of horizontal eyelid length; Moderate: Vertical deviation from the natural contour 1-2 mm in height (about the pupil height in daylight) or affecting 1/3-2/3 of horizontal eyelid length; Severe: Vertical deviation from the natural contour \> 2 mm in height (more than the pupil height in daylight) or a defect \> 2/3 of the horizontal eyelid length
Number of Eyelids With Pyogenic Granuloma
时间窗: 2 years
A pyogenic granuloma was defined as a sessile growth of 2 mm or more in diameter on the tarsal conjunctiva.
Number of Eyelids Experiencing an Unfavorable Outcome
时间窗: 2 years
At least 1 unfavorable outcome, including mild, moderate, or severe trichiasis; granuloma; or mild, moderate, or severe eyelid contour abnormality
次要结局
- Number of Eyelids With Mild, Moderate, Severe, or no Eyelid Contour Abnormality(2 years)
- Number of Eyelids With Normal, Mild, Moderate, or Severe Trachomatous Trichiasis(2 Years)
研究者
Emily Gower
Associate Professor of Ophthalmology
Johns Hopkins University