Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Intraocular pressure in the treated eye
研究概览
简要总结
The present study's main objective is to assess if there is a significant difference between either of the treatments frequently used in post-op, namely a topic cortisone-based treatment, an non-steroidal anti-inflammatory drug (NSAID) or simply a placebo, in order to gain the best long term (6 months) efficacy of the SLT.
详细描述
The selective laser trabeculoplasty (SLT) is the laser treatment of choice for treating glaucoma. A There is however a controversy regarding the use of drops post-treatment. Indeed, some would prefer not to pharmacologically modulate the post-op inflammatory response which can be an integral part of the treatment by favouring the mobilisation of the macrophages which participate to the trabeculae "cleaning". Others will prefer to calm the inflammatory reaction and choose an anti-inflammatory drug (either steroidal or non-steroidal).
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients suffering from with primary open-angle glaucoma.
- •Patients with IOP > 21 mmHg, uncontrolled with medical treatment or due to non-compliance, or to whom this is the first glaucoma treatment.
- •Patients > 18 years old, able to consent.
- •Patients consenting to the trial.
排除标准
- •Patients suffering from chronic glaucoma other than primary open-angle glaucoma
- •Patients who had changes done to their anti-glaucoma treatments over the last 6 weeks or following the SLT
- •Patients under oral corticosteroid treatment at the time of the operation or those who have stopped during the preceding month.
- •Patients suffering from an important corneal disease which interferes with the capacity to visualize the entire trabeculae.
- •Monophthalmic patients.
- •Patients who already underwent a glaucoma treatment to the eye requiring treatment.
- •Patients who already underwent a glaucoma treatment using SLT or ALT (Argon laser trabeculoplasty)
- •Patients who underwent cataract surgery in the past 3 months.
- •Pregnant patients.
结局指标
主要结局
Intraocular pressure in the treated eye
时间窗: 1 hour, 7 days, 1.5, 3 and 6 months
次要结局
- Side effects (include a slight uveitis, oculary discomfort and a spike in intraocular pressure in the immediate post-op period)(1 hour, 7 days, 1.5 months, 3 months and 6 months)
研究者
Béatrice Des Marchais
Chercheure clinicienne associée
CHU de Quebec-Universite Laval