Refractive Consequences of Epiretinal Membrane Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Refractive Error
研究概览
简要总结
Epiretinal membrane is treated with vitrectomy and peeling. Afterwards cataract is usually developed, which requires a cataract surgery.
The aim of this study is to investigate the refractive consequences of surgery for Epiretinal membrane and cataract.
Investigators investigate the sequence of surgery in patients having surgery for Epiretinal membrane and cataract in a prospective clinically randomized intervention trial. Patients are randomized to 1) start with vitrectomy, 2) start with cataract surgery, 3) combined surgery. Investigators want to find the sequence of surgery that gives the most optimal refractive result, the most stabile intraocular lens, and the minimal loss of corneal endothelial cells.
详细描述
Aim: To evaluate the impact of the sequence of surgery on the Refractive Error and the Corneal Endothelial Count in phakic individuals undergoing surgery for Epiretinal membrane.
Study design: Prospective interventional randomized clinical trial. Primary outcome: Refractive error (i.e. Intraocular lens power prediction error), Corneal Endothelial Count, and postoperative macular oedema.
Secondary outcome: Changes in axial length, anterior chamber depth and keratometry; the accuracy of formulas used to calculate the power of the intraocular lens.
Study population:
Identification of participants: Individuals referred to the Macular Surgery Clinic, Surgical Retina Team, Department of Ophthalmology, Glostrup University Hospital, Copenhagen, Denmark. The individuals should be signed up for surgery because of Epiretinal membrane at the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of Epiretinal membrane,
- •visual complaints consistent with Epiretinal membrane,
- •age more than 50 years,
- •refraction less than ± 5 diopters and astigmatism less than 3 diopters,
- •indication for vitrectomy is only Epiretinal membrane.
排除标准
- •Previous intraocular surgery or laser-refractive procedure.
- •Use of intraocular gas tamponade during the vitrectomy.
- •Intraoperative manipulation of the intraocular lens.
- •Serious complications (endophthalmitis, vitreous haemorrhage or retinal detachment).
- •History of previous head or ocular trauma.
- •Sulcus fixation of intraocular lens
结局指标
主要结局
Refractive Error
时间窗: One year
Prediction error of intraocular lens calculation (measured in diopters)
Corneal endothelial count
时间窗: One year
measured in number of cells per square millimeter (mm2)
Macula anatomy
时间窗: One year
Macula-anatomy success of surgery, i.e. the postoperative decrease of macula thickness or postoperative macular oedema. Measured in millimeter.
次要结局
- Axial length(One year)
- Anterior Chamber Depth(One year)
研究者
Hassan Hamoudi
MD
Glostrup University Hospital, Copenhagen