A Trial of Intraoperative 5-fluorouracil in Primary Glaucoma Filtration Surgery: Effects on Long Term Intraocular Pressure Control and Disease Progression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 368
- 主要终点
- Glaucoma control
研究概览
简要总结
5-fluorouracil (5FU) is an antimetabolite that has been demonstrated to have beneficial effects when injected into the subconjunctival space after glaucoma surgery (trabeculectomy). The hypothesis of this study is that a similar beneficial effect can be achieved with a single intraoperative application of 5FU. This hypothesis is tested with a randomized control study.
详细描述
Glaucoma is the commonest cause of irreversible blindness worldwide. Treatment is initially with topical medication, but when the intraocular pressure is still poorly controlled, surgical treatment is required. The surgical treatment of choice remains the trabeculectomy and this is often augmented with antimetabolite.
The choice of antimetabolite varies between surgeons, as does the indications for use. Postoperative delivery of the drug can be uncomfortable for the patient and time consuming. This study examines the potential benefits and side effect profile of intraoperative 5FU compared to unaugmented trabeculectomy.
The patients are recruited from Moorfields Eye Hospital and followed up by the staff from the glaucoma department.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A measured intraocular pressure > or equal to 22 mm Hg on at least one visit before the time of listing for surgery and while on the current drop regime.
- •The ability to complete a Humphrey 24-2 visual field test with <20% false positives, <33% false negatives and <20% fixation losses, and the presence of 2 locations > 5decibels (dB) less than normal or one location >10 dB less than normal.
- •The presence of a focal or diffuse area of optic disc rim loss, as shown by a reduction of optic rim thickness to less than one tenth of disc diameter at any point on the disc. (alternatively, optic disc which in the opinion of the patient's consultant shows glaucomatous changes as shown by focal or diffuse optic rim thinning)
排除标准
- •Anterior segment neovascularisation
- •Any intraocular epithelial ingrowth
- •Retinal or optic nerve neovascularisation
- •Previous glaucoma filtering surgery
- •Any previous intraocular surgery
- •Inability or unwillingness to give informed consent
- •Inability or unwillingness to return for postoperative follow-up as prescribed in the trial regimen
- •Unwillingness to accept randomisation
- •Patient less than 40 years of age
- •Chemotherapy in the 6 weeks prior to surgery
- •Any other disease causing visual field loss or likely to cause field loss over the next three years e.g. diabetic retinopathy, pituitary disease or stroke.
- •Pregnancy or female of childbearing age who may be pregnant at time of treatment. A pregnancy test will be performed on all women of childbearing age to rule out pregnancy.
- •Cataract that is deemed significant enough to require surgery during the course of the trial or that makes field testing or optic disc recording by either photography or the scanning laser ophthalmoscope unreliable or not technically possible.
- •Any medical condition likely to prevent the patient from regularly attending for the next three years
- •Previous conjunctival surgery at proposed site of trabeculectomy
- •Chronic use of topical or systemic steroids
- •Previous squint surgery
研究组 & 干预措施
5-fluorouracil
antimetabolite to prevent wound healing
干预措施: 5-fluorouracil (Drug)
placebo
Subconjunctival placebo.
干预措施: placebo (Drug)
结局指标
主要结局
Glaucoma control
时间窗: a minimum of 3 years follow up
Raised Intra Ocular Pressure (IOP) of \>21 millimetres of mercury (mmHg) on two or more consecutive visits recorded at the end of a visit following any physical intervention. Visual field progression that met a modified criteria of the Collaborative Normal Tension Glaucoma Study (CNTGS). Optic disc cupping progression identified by the examining clinician and confirmed with stereo-photographic documentation of the optic nerve neuroretinal rim changes read by two masked examiners. If any of these outcome measures were reached, the patient was classified as a 'trial failure' and then treated further depending on the clinicians discretion.
次要结局
- long term safety of intraoperative 5FU(a minimum of 3 years follow up)