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临床试验/NCT05757349
NCT05757349招募中不适用

A Prospective Study on the Prognosis of the Idiopathic Macular Hole With Different Prone Position Times Assisted by Novel Positioning Sensor

Tianjin Medical University Eye Hospital1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2022年10月1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
86
试验地点
1
主要终点
Macular hole closure rate

研究概览

简要总结

Idiopathic macular hole (IMH) is a fundus disease without clear etiology, most often seen in healthy women over 50 years of age, and is often associated with ocular manifestations such as loss of central vision and visual distortion. It is often associated with loss of central vision, visual distortion, and other ocular manifestations. It is currently treated by vitrectomy combined with internal limiting membranes (ILM) peeling followed by gas filling. A strict prone position for a certain period of time after surgery has a positive effect on the healing of the macular fissure. The need for a strict prone position after IMH has been demonstrated in previous studies (especially when the IMH diameter is >400 μm). However, due to the anti-human mechanics of the face-down position, patient comfort, sleep quality and quality of life are greatly compromised. Therefore, this study designed a smart head position monitoring device to assist patients in maintaining the correct position and recording the effective position time. The study was conducted to determine the shortest prone position time based on macular fissure closure, to minimize the adverse effects of postoperative position, and to obtain the maximum recovery of visual acuity and visual field.

研究设计

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

入选标准

  • Patients aged 18 years or older;
  • Patients diagnosed with IMH;
  • Patients requiring face-down position after vitrectomy combined with ILM peeling and C3F8(14%) gas filling; Tolerated face-down position after surgery;
  • Agreed to the study protocol.

排除标准

  • Myopia greater than or equal to -6.0 D; Eye axis length (AL) greater than 26.0mm;
  • Trauma, macular edema, macular degeneration, and other secondary MH with clear etiology;
  • Previous history of internal eye surgery in the operated eye;
  • Patients with local or systemic other diseases significantly affecting visual function;
  • Those who cannot maintain face-down position after surgery due to systemic factors, etc.

结局指标

主要结局

Macular hole closure rate

时间窗: 6 month postoperatively

Ratio of patients with postoperative lacunae that remained closed until the end of the follow-up time to the number of patients who reopened during the follow-up time of those who did not close after surgery

Effective face-down position time

时间窗: 1 or 3 day postoperatively

Novel positioning sensor related data cloud storage platform can record and extract effective face-down position time.

次要结局

  • Mean retinal Sensitivity (MS)(1, 3, 6 month postoperatively)
  • Best corrected visual acuity change (BCVA)(1, 3, 6 month postoperatively)
  • Retinal nerve fiber layer thickness change(1, 3, 6 month postoperatively)
  • Central 2˚ and 4˚ fixation(1, 3, 6 month postoperatively)
  • Macular ganglion cell complex thickness change (GCL+, GCL++)(1, 3, 6 month postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bojie Hu

Professor

Tianjin Medical University Eye Hospital

研究点 (1)

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