FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,410
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
研究概览
简要总结
This study aims :
- To assess the efficacy of fluorometholone 0.1% one drop twice daily for four weeks in reducing the incidence of post-operative trachomatous trichiasis (TT) when given as adjunctive therapy with TT surgery in the programmatic setting
- To assess whether such treatment is sufficiently safe for wide-scale implementation in TT programs.
- To estimate the costs of adding fluorometholone 0.1% treatment to TT surgery per case of postoperative TT averted, and to characterize the value of such treatment under a range of plausible health economic circumstances
详细描述
The investigators are pursuing an agenda to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes: perioperative topical anti-inflammatory therapy. Inflammation-whether induced by the trachoma disease process or surgery itself-most likely contributes to progressive cicatrization leading to failure of lid rotation surgery in a clinically important proportion of TT cases. The investigators hypothesize that adjunctive topical fluorometholone therapy following trichiasis surgery will reduce the risk of recurrent trichiasis and will be acceptably safe. The rationale for the efficacy aspect of this hypothesis is that interruption of inflammation postoperatively would reduce postoperative scarring/contracture driven by ongoing disease-driven inflammation and/or surgically-induced inflammation thus reducing the incidence of TT recurrence (post-operative TT) and other inflammation-related outcomes.
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, Investigator)
盲法说明
Patients, surgeons, and study staff at field site are masked to the assigned treatment group of the subject.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15 years or more, corresponding to the age of patients treated in the Fred Hollows Foundation/Federal Ministry of Health Program at field sites without general anesthesia.
- •One or both eyes with upper lid trachomatous trichiasis-with one or more eyelashes touching the eye or evidence of epilation, with a plan to undergo TT surgery on at least one upper eyelid.
- •Collection of all baseline data prior to randomization
- •Signed, informed consent (and assent, when applicable)
排除标准
- •Contraindication(s) to the use of the test articles, including a known allergy or sensitivity to the study medication (fluorometholone) or its components, and contraindication(s) to use of azithromycin
- •IOP≥22 mmHg and/or currently taking more than two ocular anti-hypertensive medications in the study eye (prior IOP-lowering surgery is acceptable; combinations of two IOP-lowering agents such as Dorzamol are considered two medications)
- •A known severe / serious ocular pathology or medical condition which may preclude study completion or increase the risk of harm in the study (e.g., suspicion of non-trachomatous active ocular infection or suspicion of glaucoma of a degree to which where an intraocular pressure spike would be vision-threatening).
- •Any condition known to be present at baseline for which it is anticipated ocular or systemic corticosteroid therapy will be required.
- •Any significant illness or condition (e.g., hypertension with systolic blood pressure≥170 mmHg and/or diastolic blood pressure≥110 mmHg) that could, in the study team's opinion, be expected to interfere with the study parameters or study conduct; or put the subject at significant risk.
- •Previous upper lid TT surgery on all eyes with upper lid TT. (If one eye has previously undergone upper lid TT surgery but another eye with upper lid TT has not, the patient may be enrolled, and only the latter eye will be counted for the primary analyses).
研究组 & 干预措施
fluorometholone
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
干预措施: Fluorometholone 0.1% Oph Susp (Drug)
Artificial Tears
one drop two times daily for four weeks
干预措施: Artificial Tears (Drug)
结局指标
主要结局
Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
时间窗: 12 months
The primary outcome measure is the postoperative recurrence of trachomatous trichiasis (TT), defined as one or more eyelashes in the upper eyelid touching the globe or evidence of epilation (lash stubs) in the upper eyelid on examination, or a history of repeat trichiasis surgery at any time in the upper eyelid during the one year follow-up period after the baseline surgery.
次要结局
- Efficacy Measure 1 - Entropion(1 year)
- Efficacy Measure 2 - Reoperation(1 year)
- Efficacy Measure 3 - Lashes(1 year)
- Efficacy Measure 4 - Health Economic Analysis(1 year)
- Safety/Adverse Outcomes 1 - Corneal Opacity(1 year)
- Safety/Adverse Outcomes 2 - Overcorrection(1 year)
- Safety/Adverse Outcomes 3 - Eyelid Abnormalities(1 year)
- Safety/Adverse Outcome 4 - Lid Closure Defect(1 year)
- Safety/Adverse Outcomes 5 - Granuloma(1 year)
- Safety/Adverse Outcomes 6 - Pain Level(1 year)
- Safety/Adverse Outcomes 7 - IOP in mmHg(4 weeks)
- Safety/Adverse Outcomes 8 - Cataract Surgery(1 year)
- Safety/Adverse Outcomes 9 - TT in Non-study Eye(1 year)
- Safety/Adverse Outcomes 10 - Adverse Events(1 year)
- Patient-reported Outcomes 1 - Patient Satisfaction(1 year)
- Patient-reported Outcomes 2 - Cosmetic Outcome(1 year)
- Patient-reported Outcomes 3 - Health Utility(1 year)
- Additional Variables 1 - Visual Acuity(1 year)
研究者
John Harold Kempen
Professor, Director of Epidemiology for Ophthalmology
Massachusetts Eye and Ear Infirmary