Clinical Evaluation of MicroPulse Transscleral Laser Cyclophotocoagulation With the Zig Zag Mode of Application in Adult Glaucomatous Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Measuring the of intraocular pressure (in mmHg) using Goldman applanation tonometer to calculate the percentage of reduction.
研究概览
简要总结
This is a prospective single-arm clinical trial in which patients with neovascular or primary open angle glaucoma with uncontrolled intraocular pressure (despite maximal tolerated anti-glaucoma medical treatment) were selected for micro-pulse trans-scleral cyclophotocoagulation using an MP3 handpiece with Iridex Cyclo G6 Laser settings (2000mW of 810 nm infrared diode laser set on micro-pulse delivery mode with 31.3 % duty cycle). The laser will be delivered over three quadrants for 90 seconds for each quadrant (total 270 sec) in Zigzag mode sparing the fourth quadrant for either further intervention or a previous surgery performed. Follow up examination (for at least 6 months) will include assessment of IOP in terms of percentage of IOP reduction and sustainability of results, BCVA, and the number of medications post-operatively.
详细描述
From the expert opinion, using the ZigZag technique would increase the success rate by 10-20 %.
Type of study: Prospective single arm clinical trial. Participants: 24 eyes of 20 consecutive patients who underwent MP-TSCPC with Zig Zag technique at a private ophthalmology center from March 16,2021 to April 12,2021 and who had at least 6 months of follow-up were included.
All cases were performed in a specialized ophthalmic center in Cairo, Egypt by the same surgeon with the same technique and standardized parameters.
On presentation, proper history was taken from all patients including personal history, history of systemic illness, family history for glaucoma, past ocular history, history of current illness including onset, course, duration of disease, causes of progression and current medication.
Ophthalmic examinations included best corrected visual acuity, anterior segment, posterior segment, gonioscopy and measuring intraocular pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 接受健康志愿者
- 是
入选标准
- •Adult patients with uncontrolled intraocular pressure
- •on maximally tolerated medical treatment.
- •Primary open angle glaucoma or neovascular glaucoma
排除标准
- •patients with other types of glaucoma.
结局指标
主要结局
Measuring the of intraocular pressure (in mmHg) using Goldman applanation tonometer to calculate the percentage of reduction.
时间窗: 6 months
Intraocular pressure will be measured in (mmHg) using Goldman applanation tonometer (an instrument that is based on Imbert-Fick law. It is considered to be the gold standard instrument for measurement of Intraocular pressure (IOP).It was named after Austrian-Swiss ophthalmologist Hans Goldmann ) before the procedure then measured in the 1 week follow up , 1 month , 3 months and 6 months follow up where each measure will be divided by the preoperative IOP to calculate the percentage of intra ocular pressure reduction and monitor the stability of IOP. the success rate will be calculated depending on the rate of IOP reduction in the last follow up.
次要结局
未报告次要终点
研究者
Ahmed Samy Abohussein
principal investigator
Helwan University