Randomized Clinical Trial Comparing Neodynium:Ytrium-aluminium-garnet (Nd:YAG) Laser and Sequential Double Frequency YAG-Nd:YAG Laser Iridotomy in Patients With Dark Iris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Laser energy
研究概览
简要总结
No single type of laser or set of laser parameters is appropriate for all type of irides. Pure Nd:YAG laser iridotomy is very effective in the light color irides. It was considered as the gold standard for iridotomy. It, however, is less effective and causes some complication such as iris hemorrhage especially in patients with dark iris.
详细描述
By using the double frequency YAG to make the initial bore and the Nd:YAG laser to complete the perforation, the technique should be able to effectively combine most of the advantages of both lasers whilst avoiding their disadvantages. It is possibly the ideal iridotomy technique to use in the Asian irides. The investigators aim to study the energy use for laser iridotomy comparing between the two techniques as well as objectively measure the variables associated with complications.
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
- •Patient in need to have a laser iridotomy
- •primary angle closure glaucoma or
- •primary angle closure or
- •primary angle closure suspect (needed repeated pupil dilation) or
- •fellow eyes of acute angle closure crisis, and
- •Age of at least 18 years, and
- •Dark iris patients (only black and dark brown color)
排除标准
- •Eye with acute angle closure crisis
- •Active conjunctiva or corneal infection or inflammation
- •Active anterior uveitis
- •History of any prior laser treatment
- •History intraocular surgery
- •Eye with corneal scar
- •Corneal haziness obscure iridotomy site
- •Endothelial cell count less than 1000 cells/mm2 (pre-laser)
- •Iris color other than black or dark brown
- •Inability to sit at the slit lamp to have laser done
研究组 & 干预措施
The sequential technique
By using the double frequency YAG laser to make the initial bore and the Nd:YAG laser to complete the perforation on iris.
干预措施: The sequential technique (Device)
The pure Nd:YAG laser technique
By using the pure Nd:YAG to make a complete perforation on iris.
干预措施: The pure Nd:YAG laser technique (Device)
结局指标
主要结局
Laser energy
时间窗: 1-hour
Total energy used to create patency on the iris
次要结局
- Bleeding(1-hour)
- Corneal endothelial cell count(12-month)
- Central corneal thickness(12-month)
- Patency of iridotomy(12-month)
- Intraocular pressure spike(1-hour)
研究者
Weerawat Kiddee
Asst.Prof.Weerawat Kiddee
Prince of Songkla University