Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Retinal diameter
研究概览
简要总结
Proliferative diabetic retinopathy (PDR) is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR is panretinal photocoagulation (PRP). In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The purpose of this study is to compare the safety and effectiveness of single-session and multiple-session PRP.
详细描述
Proliferative diabetic retinopathy (PDR) is a well-known complication for both type 1 and type 2 diabetes mellitus (DM) and it is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR, established more than four decades ago by the Diabetic Retinopathy Study (DRS), is panretinal photocoagulation (PRP). The treatment goal is to halt the progression of PDR by destroying parts of the peripheral retina in a pattern fashion and hence preserving the visually important central macular region. The tissue destruction reduces the area of ischemia and reduces the production of vascular endothelial growth factor (VEGF), which drives the formation of neovascular proliferations. In the management of PDR, panretinal photocoagulation (PRP) stands as a cornerstone treatment. In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The choice between these approaches often depends on the practitioner's preference, patient characteristics, and specific clinical circumstances.
Although both single-session and multiple-session PRP are employed in practice, there's an ongoing debate regarding their comparative safety and effectiveness. Older studies suggest a heightened risk of diabetic macular edema (DME) with single-session PRP, while newer research, particularly those involving milder laser techniques, indicates that the risk might be similar regardless of the number of sessions. This inconsistency in findings underscores the need for further research and the investigators aim to shed light over this with this prospective, controlled and randomized interventional study.
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
- •Age > 18 years.
- •Patients with type 1 or type 2 Diabetes Mellitus with newly diagnosed Proliferative Diabetic Retinopathy, PDR.
- •Visual acuity ≥ 0.1 Snellen.
- •CRT of less than 300 micrometer measured by OCT without cysts in the neuroretina.
- •Clear media and adequately dilated pupil for PRP.
排除标准
- •Intraocular surgery within the last 4 months or planned within the next 3 months.
- •Previous or current center-involved diabetic macular edema (Ci-DME).
- •Previous PRP, intravitreal treatment (IVT), or macular laser treatment in study eye.
- •Treatment with medications known to risk macular edema.
- •Media opacity preventing adequate PRP.
- •General medical condition making office laser treatment very difficult or impossible.
结局指标
主要结局
Retinal diameter
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in retinal diameter
Venular diameter
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in venular diameter
Central subfield retinal thickness (CRT)
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in CRT
Venular saturation
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in venular saturation
Vessel Length Density (VLD)
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in VLD
Lesion size
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in lesion size
Subjective overall experience of the treatment
时间窗: Baseline and 1, 3 and 6 months after treatment
Study patients' subjective overall experience of the treatment using verbal scale (VS)
Vessel Perfusion Density (VPD)
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in VPD
Foveal Avascular Zone (FAZ)
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in FAZ
Macular volume
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in macular volume
Subjective experience of pain after treatment
时间窗: Baseline and 1, 3 and 6 months after treatment
Study patients' subjective experience of pain after treatment using visual analog scale (VAS)
Arteriolar saturation
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in arteriolar saturation
Retinal function
时间窗: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in retinal function using full-field electroretinogram (ERG)
Diabetic macular edema (DME)
时间窗: Baseline and 1, 3 and 6 months after treatment
Incidence of diabetic macular edema (DME)
Cost-effectiveness
时间窗: Baseline and 1, 3 and 6 months after treatment
We intend to conduct a thorough cost-effectiveness analysis, comparing the single-session approach with the traditional multiple-session treatments. This analysis will factor in direct medical costs, including the expenses related to the laser equipment, healthcare professionals' time, and the required clinical facilities. We will also consider indirect costs such as patient travel expenses and time taken off work.
次要结局
未报告次要终点