NCT01766362已完成3 期
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 3
- 主要终点
- Macular thickness
研究概览
简要总结
The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes type 1 or 2
- •Subjects with severe non-proliferative or early proliferative diabetic retinopathy (according to the Alfediam classification)
- •Subjects with central macular thickness less than or equal to 350 µm according to spetralis OCT
- •Subjects registered with a social security agency
- •Subjects who have provided written informed consent
- •Subjects aged 18 or above
排除标准
- •Pregnancy
- •Breastfeeding women
- •Patients presenting a contra-indication to Mydriaticum and Neosynephrine
- •History of glaucoma or non-controlled ocular hypertension
- •Blindness in one eye
- •History of renal insufficiency requiring dialysis, or kidney or pancreas transplantation
- •Unbalanced diabetes requiring, in the previous 4 months, intensive insulin therapy.
- •Central macular thickness greater than 350 µm
- •Visual acuity less than 20/32 measured using an ETDRS chart
- •Proliferative diabetic retinopathy associated with "high risk factors" (extensive prepapillary neovessels and/or preretinal or prepapillary neovessels associated with preretinal of intravitreal hemorrhage)
- •Macular edema due to causes other than diabetic retinopathy (venous occlusion, uveitis) or occurring in a context of vitreomacular traction
- •Already started PRPC
- •History of eye surgery or YAG laser capsulotomy performed during the preceding 6 months
- •Subjects under legal supervision or guardianship
研究组 & 干预措施
Four sessions
Other
Every session are spaced out of month
干预措施: PRPC using Pascal laser (Procedure)
A session
Experimental
干预措施: PRPC using Pascal laser (Procedure)
结局指标
主要结局
Macular thickness
时间窗: 9 months after the start of traitement
Central macular thickness at 9 months after the start of PRPC using Pascal laser.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Pattern Scanning Laser Pan-retinal Photocoagulation in Proliferative Diabetic RetinopathyLasersTreatment OutcomeDiabetic RetinopathyNCT02816073United Christian Hospital17
已完成
不适用
Pattern Laser Versus Conventional Laser in Diabetic RetinopathyDiabetic RetinopathyNCT03672656University Hospital Ostrava30
Unknown
3 期
Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL LaserDiabetic RetinopathyNCT01304225Federal University of São Paulo60
已完成
不适用
ETDRS PRP With IVR Versus Retinal Photocoagulation Targeted to Ischemic Retina With IVR for the Treatment of PDRDiabetic RetinopathyNCT03904056São Paulo State University23
已完成
3 期
Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic RetinopathyProliferative Diabetic RetinopathyNCT01489189Jaeb Center for Health Research305