Medico-economic Evaluation of Treatment with Panretinal Photocoagulation in One Session Using Multispot Laser Versus Four Sessions Using Single-spot Laser in Patients with Severe Non-proliferative and Early Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- cost of treatment
研究概览
简要总结
Despite the fact that the efficacy of a single session of multispot laser has been demonstrated in the treatment of patients with diabetic retinopathy as compared with four sessions of single-spot laser, the management of panretinal photocoagulation in the different healthcare establishments in France has remained unchanged notably because there is no specific reimbursement for this new treatment protocol.
Although the benefits of reducing the number of sessions and thus the costs associated with the treatment for the patient and the payer seem to be obvious, the medico-economic impact of modifying the treatment strategy thanks to the technological changes must be evaluated to provide deciders with additional information.
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
- •Persons who have provided written informed consent
- •Patients with type 1 or 2 diabetes according to World Health Organisation diagnostic criteria.
- •Patients with severe non proliferative or early proliferative diabetic retinopathy
- •Visual acuity of the treated eye >= 20/32 snellen (≥ 0.63 Monoyer units or ≥ 70 letters Early treatment Diabetic Retinopathy Study)
- •Visual acuity of the contralateral eye >= 20/200 snellen (≥ 0.10 Monoyer units or ≥ 35 letters Early treatment Diabetic Retinopathy Study)
- •Patients with a central macular thickness of 350 μm or less on Spectral Domain - Optical Coherence Tomography
- •Patients with national health insurance cover
- •Patients over 18 years old
排除标准
- •Uncontrolled diabetes in the previous 6 months with intensive insulin therapy (glycated haemoglobin > 11).
- •Uncontrolled hypertension.
- •Florid diabetic retinopathy floride.
- •Macular oedema due to causes other than diabetic retinopathy or in a context of vitreomacular traction.
- •History of intravitreal treatment with anti-angiogenic agent or corticosteroids within the 12 previous months.
- •History of treatment with laser in panretinal photocoagulation or focal laser on the treated eye.
- •History of eye surgery or laser capsulotomy within the previous 6 months
- •History of renal failure requiring dialysis or kidney transplantation for diabetic nephropathy.
- •Contra-indication for Tropicamide or Neo-synephrine
- •History of uncontrolled glaucoma or hypertonia
- •Patient with aphakia
- •Adult under guardianship
- •Pegnant or breast-feeding women
研究组 & 干预措施
1 session
干预措施: multispot panretinal photocoagulation (Procedure)
4 sessions
干预措施: monospot panretinal photocoagulation (Procedure)
结局指标
主要结局
cost of treatment
时间窗: 9 months after the start of treatment
次要结局
未报告次要终点