Selective Retina Therapy (SRT) for Clinically Significant Diabetic Macular
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 主要终点
- best-corrected visual acuity
研究概览
简要总结
Selective Retina Therapy (SRT) is an effective and safe laser treatment of clinically significant diabetic macular edema which targets the retinal pigment epithelium while sparing the neurosensory retina.
详细描述
Abstract:
OBJECTIVE: To evaluate effectivity and safety of Selective Retina Therapy (SRT) for diabetic macular edema (DME).
DESIGN: Prospective two-center interventional uncontrolled case series. PARTICIPANTS: 39 eyes of 39 patients with previously untreated non-ischemic DME.
INTERVENTION: Focal laser treatment with an SRT-Laser which selectively affects the retinal pigment epithelium while sparing the photoreceptor layer. The pulse energy was individually adjusted to achieve angiographically visible but funduscopically invisible effects. Optoacoustic measurements were performed to detect the individual threshold of RPE damage during laser treatment and correlated with funduscopy and fundus fluorescein angiography (FFA) or indocyanine green angiography. Follow-up at 3 and 6 months post treatment included best-corrected ETDRS visual acuity (BCVA), FFA, fundus photography, and retinal thickness measured by optical coherence tomography (OCT).
MAIN OUTCOME MEASURES: Change of BCVA, change of retinal thickness, presence of hard exudates and leakage in FFA, specificity and sensitivity of optoacoustic measurements.
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
- Single (Outcomes Assessor)
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
- •Minimum age of 18 years and the presence of clinically significant DME according to the criteria of the ETDRS study
排除标准
- •Ischemic diabetic macular edema, significant media opacity compromising the interpretation of fluorescein angiography and fundus photography, previous intraocular surgery, previous macular laser treatment, other retinal or ocular diseases, and known allergic hypersensitivity to fluorescein, indocyanine green, or iodine. General exclusion criteria included pregnancy or breast-feeding and significant medical conditions such as renal failure.
结局指标
主要结局
best-corrected visual acuity
时间窗: 2 years
次要结局
- change of retinal thickness, presence of hard exudates and leakage in FFA, specificity and sensitivity of optoacoustic measurements(2 years)
研究者
Jost Hillenkamp
Oberarzt, Dept. of Ophthalmology, University of Schleswig-Holstein, Kiel, Germany
University Hospital Schleswig-Holstein