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临床试验/NCT04054830
NCT04054830进行中(未招募)4 期

Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy. An Investigator-initiated Randomized Study (The SNAP Study)

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
70
试验地点
1
主要终点
Intraocular pressure (IOP)

研究概览

简要总结

PURPOSE:

Glaucoma is the leading cause of non-curable blindness globally. Patients with glaucoma will get a gradual narrowing of the visual fields caused by compression at the optic nerve head due to increased intraocular pressure. Thus the main preventive strategy is to reduce intraocular pressure, initially by eye drops and/or laser treatment but in some patients surgery is warranted. The surgical procedure (trabeculectomy) most widely performed worldwide creates a path from the anterior chamber to the subconjunctival space and thereby lowers the IOP by producing a more efficient drainage of the aqueous humour. Surgical success depends upon controlling post-operative inflammation to ensure a functional drainage. The purpose of this blinded, randomized study is to investigate which anti-inflammatory treatment provides better long-term control of intra-ocular pressure (IOP) following glaucoma surgery (trabeculectomy) by comparing topical NSAIDs to topical steroids. Additionally, we want to explore the mechanisms behind the pathophysiology of glaucoma by evaluating retinal and optic nerve head perfusion before and after IOP lowering surgery. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.

MAIN HYPOTHESIS:

  • NSAIDs and steroids are equally effective in assuring long-term filtering function and controlling IOP after trabeculectomy but may be associated with different risk profiles and bleb morphology
  • Patients with lower post-operative IOP demonstrate less progression of visual field loss
  • Trabeculectomy lowers IOP and provides better microcirculation in and oxygenation of inner retinal layers (i.e. ganglion cell layer) and the optic nerve head

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) or ocular hypertension
  • >50 years
  • Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months
  • Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology at Rigshospitalet-Glostrup, Denmark
  • Informed consent to participation and ability to comply with study procedures

排除标准

  • Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
  • Prior intraocular surgery, except from cataract surgery. If cataract surgery has been performed, it should at least be 6 months prior to surgery
  • Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma
  • Steroid responders
  • Pregnancy
  • Fertile women, i.e. women who are not menopausal and women who breastfeed
  • Patients in systemic treatment with steroid or NSAID

研究组 & 干预措施

Topical, preservative-free NSAID

Experimental

Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

干预措施: Voltaren Ophtha 1 mg/ml, GSK (Drug)

Topical, preservative-free steroid

Active Comparator

Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

干预措施: Monopex 1 mg/ml, Théa (Drug)

Topical, preservative-free NSAID (Voltaren Ophtha 1 mg/ml, GSK

Experimental

Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per wee

干预措施: Voltaren Ophtha 1 mg/ml, GSK (Drug)

Topical, preservative-free NSAID (Voltaren Ophtha 1 mg/ml, GSK

Experimental

Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per wee

干预措施: Monopex 1 mg/ml, Théa (Drug)

结局指标

主要结局

Intraocular pressure (IOP)

时间窗: 12 months

Postoperative intraocular pressure (IOP) by applanation tonometry

次要结局

  • Visual field(12 months, 24 months)
  • Optical nerve damage(12 months, 24 months)
  • Best corrected visual acuity(12 months, 24 months)
  • Surgical success(12 months, 24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Afrouz Ahmadzadeh

MD, PhD-student

Rigshospitalet, Denmark

研究点 (1)

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