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临床试验/NCT04676217
NCT04676217已完成不适用

Position Related Changes in Macular Hole Morphology Before and After Surgery

Helse Stavanger HF2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Macular hole mid area

研究概览

简要总结

Macular hole is a full thickness retinal defect in the very centre of the retina that gives the sharpest vision. The condition causes a substantial deterioration of visual acuity, and operative measures are necessary in order to close the defect and improve the visual function. A macular hole has varying degrees of retinal oedema surrounding the hole edges. The oedema is maintained by continuous of liquid into the tissue and effectively prevents spontaneous closure. For that reason it is essential for macular hole closure that the macula has minimal contact with intraocular fluid in the very early postoperative phase. This is why the treatment included a long-lasting intraocular gas tamponade and typically, one week of face-down positioning (FDP) after surgery.Our aim is to investigate the impact of diurnal, orthostatic, and gravitational variations on macular hole morphology before and after surgery. The participants will be examinated with optical coherence tomography 8-10 am, 1 pm, and 3 pm. Between 8 am and 1 pm ,the patient is encouraged to an upright position. After the 1 pm examination, the patient will be positioned flat on the side of the eye with macular hole until the 3 pm examination. The surgery will be performed before 10 am. Postoperatively a randomization to face down positioning or no positioning until 3 am. Optical coherence tomography images through gas tamponade is made at 3 am.

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
None

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 macular hole
  • •Able to sign informed consent
  • •Signed informed consent

排除标准

  • •Previous vitreoretinal surgery in the study eye
  • •Secondary macular holes caused by other conditions than vitreomacular traction
  • •Myopic macular hole, i.e. excessive myopia (more than -6 dioptres)
  • •Posttraumatic macular hole
  • •Macular holes secondary to retinal detachment or other retinal diseases

研究组 & 干预措施

FDP

Active Comparator

Face down positioning

干预措施: Postoperative positioning advice (Procedure)

NSP

Experimental

No positioning named "non-supine positioning". Participants are to avoid recumbent positioning.

干预措施: Postoperative positioning advice (Procedure)

结局指标

主要结局

Macular hole mid area

时间窗: 1 day

Square micrometer

Central retinal thickness

时间窗: 1 day

Micrometer

Macular hole mid diameter

时间窗: 1 day

Micrometer

Macular hole basal diameter

时间窗: 1 day

Micrometer

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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