Retrospective Study Within the Brugmann University Hospital of the Navilas ® Micropulse Laser Treatment for Macular Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Scar - assessed by fluorescein angiography
研究概览
简要总结
The Navilas® micropulse laser can be used to treat patients with macular edema and good visual acuity, which therefore do not fall within the indications for conventional treatments by intravitreal injections.
The CHU Brugmann Hospital is the only center to own this laser in Belgium.This study aims to evaluate the efficacy of this laser.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Diffuse macular edema without focal edema source accessible by focal laser (e.g. capillary telangiectasia)
- •Central retinal thickness ≤ 400microns.
- •Patient does not meet the reimbursement criteria for intra-vitreous injections(IVI) of anti-VEGF (eg AV> 5/10).
- •IVI are contraindicated.
- •Physician considers that it is preferable to space out the injections because of the side effects (eg. ocular disturbance during IVI, eye pain, sensation of a foreign body, spots in the visual field generating a visual gene etc.)
- •Patient wishing to space the anti-VEGF IVI.
排除标准
- •Macular edema of a different etiology than diabetic macular edema or venous thrombosis (e.g. cataract extraction, vitreomacular traction, epiretinal membrane etc.)
- •Central retinal thickness > 400 microns.
- •The eye presents a focal edematous maculopathy accessible to conventional laser.
结局指标
主要结局
Scar - assessed by fluorescein angiography
时间窗: Three months after treatment
Visual acuity
时间窗: Baseline versus three months after treatment
Periodicity of anti-VEGF injections
时间窗: Baseline versus three months after treatment
Scar - assessed by optical coherence tomography
时间窗: Three months after treatment
Scar - assessed by auto-fluorescence fundus images
时间窗: Three months after treatment
Retinal thickness change
时间窗: Baseline versus three months after treatment
次要结局
未报告次要终点
研究者
Laurence Postelmans
Head of the Ophtalmology Department
Brugmann University Hospital