Randomized, Prospective, Descriptive and Comparative Clinical Study of Macular Grasping Damage in Patients Undergoing Pars Plana Vitrectomy and Peeling of the Internal Limiting Membrane, Operated by Traditional Microscope or NGENUITY® 3D Visualization System With Heads-up Display System. A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- SANFL detection
研究概览
简要总结
Randomized, prospective, descriptive and comparative clinical study. The comparison is between a group of patients affected by macular pucker or macular hole, whose macular peeling is performed using a traditional optical microscope (Leica F40) - control arm, and a group of patients affected by macular pucker or macular hole whose macular peeling is performed by 3D heads-up microscopy system (NGenuity 3D, Alcon) - experimental arm.
It is a blind study for both the operator that collects data and for the statistician.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affected by macular pucker or macular hole, whose internal limiting membrane peeling need to be performed
- •Willing and able to understand and sign an informed consent
- •Willing and able to undergo postoperative examinations of the protocol program:
- •≥ 21 years of age, of both sexes and any race
排除标准
- •History of ocular trauma or amblyopia.
- •Other ocular pathologies (glaucoma, uveitis, diabetic retinopathy, diabetic macular edema, macular degeneration, Irvine Gass Syndrome, degenerative myopia, malformation of the optic disc, i.e.: tilted disc, optic disc pit, posterior staphyloma)
- •Multiple procedures programmed during the surgery
- •Pregnancy, lactation or programmed pregnancy during the course of the study.
结局指标
主要结局
SANFL detection
时间窗: 2 weeks after surgery
Post-surgical analysis of SANFL (Swelling of the Arcuate Nerve Fiber Layer) measured on infrared, blue auto-fluorescence images and OCT images of peripapillary region
次要结局
- ILM staining(during surgery)
- ILM grasping(during surgery)
- Light(during surgery)
- BCVA(baseline, 1 month and 3 months after surgery)
- Intraoperative time(during surgery)
- Surgeon ergonomics(during surgery)
研究者
Anna Rita Daniele, MD
Medical Doctor
Santa Maria della Misericordia Rovigo Hospital