A Prospective Study on a New Pattern of Retinal Laser Treatment for Proliferative Diabetic Retinopathy (PDR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- BCVA
研究概览
简要总结
The objective of the study is to evaluate the efficacy of a new pattern of argon-laser in treating patients with proliferative diabetic retinopathy (PDR).
详细描述
Argon-laser pan retinal photocoagulation (PRP) is the first-line therapy for proliferative diabetic retinopathy (PDR) nowadays, which is believed to function by reducing retinal ischemia and decreasing the stimulation for neovascularization. However, diabetic retinopathy (DR) would still progress uncontrollably even after PRP, and PRP would result in reduction in visual acuity and loss of peripheral visual field, which may be influenced by the distribution pattern of the retinal laser treatment.
A variety of modified argon-laser patterns have been reported - a more central PRP, a more peripheral PRP, a central-sparing PRP or an extended-targeted PRP, yet the risk of developing neovascularization is higher in retina around the posterior vascular arcades and alongside the major retinal vessels.
This study will include 300 patients with PDR, who will be treated with a new pattern of argon-laser. An initial retinal laser would be given in the posterior retina outside the arcades and the mid-peripheral retina flanking the large vessels. Then we will conduct no less than 2 years follow-up. Further peripheral PRP and anti-VEGF administration would be added only if neovascularization progress, aiming to stop DR progression with the minimum of laser energy.
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
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects having given free and informed consent to take part in the study.
- •Subjects with diabetes mellitus (DM) under stable treatment during the study, aged 18y to 70y, with no significant underlying systemic diseases (such as impaired renal function, severe cardiac disease, etc.);
- •Subjects clinically diagnosed PDR, with the presence of neovascularization confirmed by ultra-widefield fundus photography and widefield OCT angiography.
排除标准
- •Previous treatment with PRP;
- •Previous treatment with anti-VEGF agents or corticosteroids within 3 months;
- •2. Subjects with severe cataract, massive vitreous hemorrhage, or extensive preretinal hemorrhage that makes pan retinal photocoagulation impossible;
- •Unable to tolerate argon-laser retinal treatment.;
- •Subjects with vitreous macular traction or traction retinal detachment need to be performed with vitrectomy;
- •Subjects with retinal vascular occlusion, age-related macular degeneration, retinal angioma, uveitis, glaucoma, optic neuropathy, or other ocular diseases that can lead to vitreous hemorrhage and/or neovascularization;
- •Other conditions that the researcher found improper to be included into this study.
结局指标
主要结局
BCVA
时间窗: From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)
BCVA stands for best-corrected visual acuity, measured by Snellen chart.
CMT
时间窗: From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)
CMT stands for central macular thickness, measured with optical coherence tomography (OCT) images, which serves as one of the key indicators of DR progression.
VF loss
时间窗: 1 year and 2 years after the initial laser treatment during the follow-up period.
VF stands for visual field. Mean deviation would be used to evaluate the VF loss.
Further treatment
时间窗: From enrollment to the end of the 2-year follow-up period.
Any further laser treatment, anti-VEGF treatment or vitrectomy would be recorded.
次要结局
未报告次要终点