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临床试验/NCT04035343
NCT04035343招募中不适用

Difference In Anatomic Integrity in Vitrectomy for Macula Off Rhegmatogenous RetiNal Detachments With Face Down Compared to Supine Positioning (the DIAMOND Study)

Unity Health Toronto2 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2019年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
324
试验地点
2
主要终点
Retinal displacement

研究概览

简要总结

Patients may experience metamorphopsia, or image distortion, after having vitrectomy to repair their rhegmatogenous retinal detachments especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. It is thought that the retina slips inferiorly due to the residual subretinal fluid shifting as the patient transitions from the supine position intraoperatively to the sitting up position in the immediate postoperative period. By having the patient immediate position facedown or according to the retinal break, the risk of slippage is theoretically decreased.

详细描述

Rhegmatogenous retinal detachments (RRD) are a sight-threatening condition with an incidence of approximately 10 per 100 000 people. RRDs can be broadly classified into those with the macula still attached, and those with the macula detached. Visual prognosis for RRDs with attached macula tend to be much better than those with detached macula. Pars plana vitrectomy (PPV) is one of the procedures used to treat RRD. PPV is carried out in the operating room under regional anesthestic, and often times sedation. The retina is reattached by either draining the subretinal fluid through a peripheral retinal break, by draining the subretinal fluid through a posterior retinotomy, or by using a heavier-than-water liquid such as perfluorocarbon to push out the subretinal fluid. At the end of the surgery, the vitreous cavity is filled with a substance that will tamponade the retina to the wall of the eye. Tamponade agents can be temporary, such as sulfur hexafluoride (SF6) and octafluoropropane (C3F8), or long term, such as silicone oil. After the surgery, patients are usually told to put their facedown allowing the tamponade agent to keep the macula attached while the remaining subretinal fluid is reabsorbed by the retinal pigment epithelium. Alternatively, some surgeons ask that their patients position according to the location of their retinal breaks with the aim for the buoyant gas bubble to cover the break or breaks. Patients may experience metamorphopsia, or image distortion, after having their RRD repaired especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. Supine positioning in theory covers all break locations as usually breaks occur in the anterior part of the retina near the vitreous base. This position has the advantage of being more ergonomic than face down. Depending on the results, this study might provide evidence for the current standard of care, which is face down positioning for the first day after vitrectomy for retinal detachment. Or, if supine positioning demonstrates superiority in reducing the risk of retinal displacement, patients would be able to maintain a more comfortable position after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Diagnosis of primary rhegmatogenous retinal detachment needing pars plana vitrectomy with the detachment involving at least one of the temporal vascular arcades, which would allow retinal displacement to be detected on fundus autofluorescence photography

排除标准

  • Rhegmatogenous retinal detachment with an attached macula
  • Proliferative retinopathy grade C or worst
  • Prior vitrectomy for retinal detachment. Patients having had pneumatic retinopexy that failed to completely reattach the retina and therefore now needing vitrectomy are allowed into the study
  • History of preoperative binocular diplopia
  • Tamponade with silicone oil instead of gas
  • Inability to maintain post operation head positioning
  • Mental incapacity

结局指标

主要结局

Retinal displacement

时间窗: 3 months

The presence of retinal vessels printing on fundus autofluorescence imaging.

次要结局

  • Visual Distortion(3 months)
  • Optical coherence tomography angiography (OCTA) changes(3 months)
  • Aniseikonia(3 months)
  • Optical coherence tomography (OCT) changes(3 months)
  • Best corrected Visual Acuity measured in "Early Treatment of Diabetic Retinopathy Study" letters(3 months)
  • Metamorphopsia(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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