Incidence and Risk Factors for Cystoid Macular Edema After Primary Vitrectomy With Gas Tamponade for Rhegmatogenous Retinal Detachment: a National Study Group
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- incidence of cystoid macular edema
研究概览
简要总结
To investigate the incidence of cystoid macular edema in eyes with primary rhegmatogenous retinal detachment successfully treated with vitrectomy with gas tamponade, and to evaluate the clinical variables associated with its development.
详细描述
this is an observational, retrospective, multicentre study. The study is based on the retrospective collection of clinical data from patients undergoing gas tamponade vitrectomy for rhegmatogenous retinal detachment. The collection of such data by the investigators will take place at each participating center anonymously.
demographics, systemic, and preoperative, intraoperative and post-operative data will be collected The sample size was calculated to obtain approximately 200 patients with cystoid macular edema. Since cystoid macular edema has been detected in 13% of patients after retinal detachment gas vitrectomy, and assuming that this event can occur between 10% and 15% of cases, the study will include at least 2000 cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •primary rhegmatogenous retinal detachment treated with vitrectomy with gas tamponade;
- •follow-up of 3 months or more;
- •age > 18 years ;
- •no previous eye surgery, except cataract surgery performed at least 6 months after hospitalization for retinal detachment;
- •anatomical success, i.e. retinal re-attachment, after a single gas vitrectomy;
- •no other eye surgery during follow-up;
- •availability of optical coherence tomography (OCT) imaging
排除标准
- •history of other eye diseases (glaucoma, age-related macular degeneration, uveitis, diabetic retinopathy, maculopathy);
- •macular hole;
- •recurrent retinal detachment;
- •use of silicone oil is used as a tamponading agent
结局指标
主要结局
incidence of cystoid macular edema
时间窗: from 1 month up to 6 months after surgery
cystoid macular edema assessed by OCT (central subfield thickness \>310 micron, with presence of intraretinal cystic areas of low reflectivity in OPL) visual acuity
次要结局
- factors related to development of macular edema(from 1 month up to 6 months after surgery)
研究者
Antonio Longo
Associate Professor
University of Catania