Single Session of Pattern Scanning Laser Versus Multiple Sessions of Conventional Laser for Panretinal Photocoagulation in Diabetic Retinopathy: Efficacy, Safety and Painfulness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Clinical efficiency - progression of diabetic retinopathy, scored by calculating of microaneurisms and intraretinal hemorrhages
研究概览
简要总结
Purpose: To evaluate the clinical efficiency, safety and painfulness of retinal laser photocoagulation employing a pattern scanning laser system Pascal given in a single-session versus conventional laser multiple-session treatment of the same patient with diabetic retinopathy.
Methods: The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic, Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on one eye using the multispot panretinal photocoagulation given in a single-session system Pascal (SSP) (OptiMedica, Santa Clara, California). On the other eye laser treatment was carried out by the classic conventional multiple-session method (MSM).
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic retinopathy
排除标准
- 未提供
研究组 & 干预措施
pattern scanning laser system Pascal
干预措施: lasercoagulation by Pascal system (Device)
conventional laser
干预措施: conventional laser (Device)
结局指标
主要结局
Clinical efficiency - progression of diabetic retinopathy, scored by calculating of microaneurisms and intraretinal hemorrhages
时间窗: 1 year
progression of diabetic retinopathy after pattern PASCAL laser versus conventional laser. Each item is scored by calculating of microaneurisms and intraretinal hemorrhages
Pain assessed by NRS
时间窗: 1 day
painfulness of pattern PASCAL laser versus conventional laser Each item is scored 0-10 (0 - no pain, 10 - pain as bad as can be)
次要结局
- Satisfaction assessed by the VAS(1 day)