Computer-guided Selective Laser Trabeculoplasty (PSLT) in the Treatment of Ocular Hypertension and Open-angle Glaucoma Compared to Prostaglandin Analogue Eye Drops: a Non-inferiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Intraocular pressure change
研究概览
简要总结
This study aims to compare the efficacy of PSLT and the topical use of prostaglandin-like hypotensive eye drops in the treatment of ocular hypertensive or glaucomatous patients in decreasing intraocular pressure and measuring changes in functional, structural and biomechanical parameters evaluated by computerized perimetry and optical coherence tomography (OCT) related to pressure change resulting from treatments
详细描述
Patients with a diagnosis of ocular hypertension or bilateral glaucoma, naive or on treatment with up to two classes of hypotensive eye drops will be invited to participate in the study.
These patients will have both eyes included in the study. A randomization will be made to allocate one eye to receive treatment with PSLT (treatment group), while the contralateral eye will receive treatment with prostaglandin eye drops (control).
Patients will be followed up for 12 months and periodically tonometry, computerized perimetry, water overload test and OCT will be performed.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of ocular hypertension (IOP ≥ 24 mmHg in both eyes) or diagnosis of open-angle glaucoma (POAG) in both eyes
- •Proper visualization of angle structures and 360 degree open angles in both eyes
- •No previous intraocular surgery with the exception of phacoemulsification with intraocular lens implantation
- •No use of systemic medications known to increase IOP
排除标准
- •Patients using more than two glaucoma medications
- •Evidence of any other eye disease that could affect IOP measurement
- •Diagnosis of other types of glaucoma
- •Patient with mean deviation (MD) less than -12 decibels (dB) on visual perimetry (severe disease)
- •Patients with unilateral glaucoma
研究组 & 干预措施
Pattern Selective Laser Trabeculoplasty
PSLT will be performed using the Pascal Streamline 577 laser (Topcon Inc., Tokyo, Japan). The laser spot is directed at the anterior chamber angle encompassing the pigmented and non-pigmented trabecular meshwork. Laser power is titrated by placing a laser mark in the lower quadrant with an exposure duration of 10 milliseconds (ms). The initial energy of 500 megawatts (mW) is selected and the power is reduced or increased until a slight whitening of the trabecular meshwork is minimally noticed. This power is then maintained and the pulse duration is automatically reduced to 5ms to produce invisible injury. The treatment is administered in 32 steps, each pattern consists of 36 stitches: 3 rows of 13 stitches each (total of 1152), with zero space between adjacent stitches.
干预措施: PSLT (Procedure)
Prostaglandin analogue eye drops
Prostaglandin analogue eye drops (latanoprost, bimatoprost or travoprost) will be prescribed
干预措施: Prostaglandin analogue eye drops (Drug)
结局指标
主要结局
Intraocular pressure change
时间窗: 1 week, 2 months, 9 months, 12 months
Intra-ocular pressure change will be similar in both groups
次要结局
- Functional damage(1 week, 9 months, 12 months)
- Structural damage(1 week, 9 months, 12 months)
研究者
Helena Messinger Pakter
Professor
Federal University of Rio Grande do Sul