A Prospective, Randomized Study Comparing the Effects of Selective Laser Trabeculoplasty and Travoprost on the Circadian Intraocular Pressure Variation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of circadian intraocular pressure
研究概览
简要总结
The investigators conduct this study to access the effect of selective laser trabeculoplasty on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension glaucoma and ocular hypertension. This treatment effect is compared with that of the prostaglandin analogue, travoprost.
详细描述
Selective laser trabeculoplasty is an effective treatment for lowering intraocular pressure in patients with open-angle glaucoma. Clinical evaluations of its effectiveness in individual patients usually are derived from baseline and post-laser measurements of intraocular pressure during office hours in the sitting position. Only a few studies have examined the efficacy of laser trabeculoplasty beyond office hours. Although the 24-hour effect of laser trabeculoplasty has been studied ,the study was conducted before the use of these new and more potent intraocular pressure lowering drugs. So it doesn't have any study to determine the effect of selective laser trabeculoplasty and travoprost to reduce the diurnal and nocturnal variation of Iintraocular pressure.
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 (Participant)
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
- •Age > 18 year-old
- •Patients who were diagnosed as primary open-angle glaucoma, normal tension glaucoma, and ocular hypertension either newly diagnosed or currently on medical therapy.
- •Agree to participate in the study, accept to be randomized to receive treatment, and willing to sign an informed consent
排除标准
- •Related to the severity of disease and visual acuity status
- •Advance glaucoma in the study eye
- •Have a very high intraocular pressure that need immediate treatment to prevent retinal vein occlusion (intraocular pressure >30 mmHg)
- •Currently on maximal tolerated medical treatment and unable to control intraocular pressure
- •Currently on oral carbonic anhydrase inhibitor for intraocular pressure control
- •Single eye, the other eye blind from any cause
- •Related to surgical procedures
- •Prior laser trabeculoplasty
- •Prior glaucoma surgery
- •Prior retinal surgery
- •Underwent less than 3-month cataract extraction
- •Potential need for other ocular surgery within the 2-3-month follow-up period since enrollment Related to underlying and ocular history
- •History of diabetic retinopathy staged as severe non-proliferative or worse
- •Narrow iridocorneal angle
- •Ocular condition precluding visualization of trabecular meshwork
- •Recently have ocular inflammation of any cause
- •Previous history of ocular trauma
- •Pregnant or breast-feeding women Related to the difficulty of having reliable measurements
- •History of refractive surgery or any keratoplastic procedure
- •Corneal opacities or diseases making no suitable tonometry
- •Subjects with having poor or eccentric fixation or nystagmus
- •Excessive eye squeezing
- •Unable to lay down for measuring intraocular pressure in supine position during the night time
- •Unable to have intraocular pressure checked every 2-hour such as have complicated underlying diseases or having sleep deprivation Related to allergy
- •Known allergy to topical anesthesia
- •Known allergy to fluorescein solution
- •Known allergy to travoprost Related to compliance
- •Impairment preventing adequate understanding to sign an informed consent
- •Subject has demonstrated potential for non-compliance with the study protocol
- •Unwilling to be randomized to receive treatment
- •Unwilling to be washed out from currently treated drug(s).
研究组 & 干预措施
Selective laser trabeculoplasty
Treating with the selective laser trabeculoplasty
干预措施: Selective laser trabeculoplasty (Device)
Travoprost
Using eye drop: travoprost
干预措施: Travoprost (Drug)
结局指标
主要结局
Change of circadian intraocular pressure
时间窗: Six weeks after recieving treatment
intraocular pressure values measured during daytime and nighttime, compare between selective laser trabeculoplasty and travoprost (include pre- and post-treatment intraocular pressure values)
次要结局
- Position related intraocular pressure(Six weeks after the treatments)
- Ocular surface disease(Six weeks after the treatments)
研究者
Weerawat Kiddee
Weerawat Kiddee
Prince of Songkla University