Randomized Prospective Study of Superior Versus Temporal Laser Peripheral Iridotomy (LPI) in Primary Angle Closure Suspects (PACS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Dysphotopsias noted from baseline visit before procedure till 3 months after procedure
研究概览
简要总结
Basic Study Design: Prospective, randomized, single-center, single-blinded study to compare dysphotopsias and pain recollection immediately 2 weeks, and 3 months after LPI in PACS patients who have a clear indication for bilateral LPI. Our null hypothesis is that there is no difference in dysphotopsia or pain levels by LPI position. Our alternate hypothesis is that there are more dysphotopsias superiorly and more pain temporally.
详细描述
The study objective is to describe the difference in the incidence of dysphotopsias and sensation of pain both immediately, 2 weeks and 3 months after superior or temporal LPI. The main primary outcome variable will be the presence of dysphotopsias and the recollection of pain graded by a standardized pain scale.
Stratified Block Randomization: 200 patients will be recruited from participating centre. For each patient, the order of the eye to be treated as well as the position of the LPI superior or temporal will be randomized.
Methods:
Subjects: Patients included in the study will be patients referred for a glaucoma evaluation or in follow up at Sunnybrook Science Center who are diagnosed as PACS and have therefore an indication for bilateral LPIs.
Interventions: All patients eligible will be examined by the principal investigator, including a slit lamp assessment of the anterior segment, gonioscopy of the angle and stereoscopic optic nerve examination with a 78 Diopters lens. Intraocular pressure (IOP) will be measured with applanation tonometry. Patients will be assessed with a macular and optic nerve OCT to rule out glaucoma.
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
- 是
入选标准
- •* clinical evidence of bilateral occludable angles (PACS) defined as:
- •Peripheral anterior synechia (PAS) absent and trabecular meshwork not visible in ≥6 clock hours under non-indentation gonioscopy, Along with,
- •absence of PAC or PACG, in both eyes.
- •macular and optic nerve OCT within the 95% range of the normative database for patients to be included in this study.
排除标准
- •evidence of unilateral PACS,
- •a history suggestive of an acute angle closure attack (based on symptoms) documented intraocular pressure over 30 mmHg,
- •or any sign of Angle Closure Glaucoma (manifest glaucomatous neuropathy detected by OCT).
- •Patients with previous ocular surgeries will also be excluded.
研究组 & 干预措施
Superior LPI placement
Each participant will be randomized to receive an LPI placement superiorly in one eye.
干预措施: Yag Laser peripheral Iridotomy (Procedure)
Temporal LPI placement
Each participant will be randomized to receive an LPI placement temporally in one eye.
干预措施: Yag Laser peripheral Iridotomy (Procedure)
结局指标
主要结局
Dysphotopsias noted from baseline visit before procedure till 3 months after procedure
时间窗: 3 months from baseline visit
We will inquire if patients experienced any of the following before and/or after the iridotomy: halo, lines, crescent, ghost image, glare, spots, shadows, blurring, or other unlisted visual disturbances. This will be part of the questionnaire completed before the procedure, at 2 weeks, and at 3 months.
次要结局
- Pain during the baseline visit procedure and recollection of pain till 3 months after procedure(3 months from baseline visit)
研究者
Dr. Catherine Birt
Principal Investigator
Sunnybrook Health Sciences Centre