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临床试验/NCT04337944
NCT04337944招募中不适用

Impact of Endoscopic Assisted Anterior Hyaloid Peeling in Boston Type 1 Keratoprosthesis in Reducing Postoperative Complications

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Rate of retinal detachment

研究概览

简要总结

Common complications of the Boston keratoprosthesis type 1 (KPro) surgery include retroprosthetic membrane formation, glaucoma, and retinal detachment. Often pars plana vitrectomy (PPV) is performed at the same time as KPro surgery for different indications. It has been shown to reduce postoperative complications in comparison to when it is performed after the KPro surgery. Patients who receive a complete PPV with peeling of the anterior hyaloid membrane have a lower incidence of retroprosthetic membrane formation and less vision loss due to glaucoma when compared to patients with partial PPV or anterior vitrectomy. During a complete PPV, peeling of the anterior hyaloid membrane is a difficult step because visualisation is poor, but it can be improved using endoscopy. The investigators suggest that peeling of the anterior hyaloid membrane assisted by endoscopy during KPro surgery would decrease postoperative complications in comparison to a PPV done after KPro surgery and without endoscopy.

详细描述

Boston keratoprosthesis type 1 (KPro) surgery is the most common corneal graft and is used to restore vision in patients with high risk of failure with traditional penetrating keratoplasty. Common complications of KPro surgery include retroprosthetic membrane formation behind the backplate of the KPro. Glaucoma is the most common threat to vision rehabilitation in patients with KPro. Glaucoma is often present before surgery and progresses after KPro, seven times faster than in patients with only glaucoma. Retinal detachment is a common posterior segment complication that arises post-KPro and can lead to a serious loss of vision. Pars plana vitrectomy (PPV) is the standard treatment for patients with vitreoretinal diseases and opacities. PPV can include peeling of the anterior hyaloid membrane to ensure total resection of the vitreous body. PPV allows for example for retroprosthetic membrane excision, installation or revision of a glaucoma drainage device, or repair of retinal detachment. Often PPV is performed at the same time as KPro surgery for different indications. It has been shown to reduce postoperative complications in comparison to when it is performed after the KPro surgery. Patients who receive a complete PPV with peeling of the anterior hyaloid membrane have a lower incidence of retroprosthetic membrane formation and less vision loss due to glaucoma when compared to patients with partial PPV or anterior vitrectomy. Combined surgeries of KPro and PPV offer a complete evaluation of the optic nerve and of the retina, which would not be possible otherwise. During a complete PPV, peeling of the anterior hyaloid membrane is a difficult step because visualisation is poor, especially with a KPro in place. Visualisation can be improved using endoscopy to visualize the inside of the eye over 360 degrees. The investigators suggest that peeling of the anterior hyaloid membrane assisted by endoscopy during KPro surgery would decrease postoperative complications in comparison to a PPV done after KPro surgery and without endoscopy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged from 18 to 80 years old
  • Informed consent
  • Boston keratoprosthesis candidate
  • Pars plana vitrectomy candidate
  • Ability to be followed for the duration of the study

排除标准

  • Aged less than 18 or more than 80 years old
  • Inability to give informed consent
  • Repeat Boston keratoprosthesis
  • Repeat pars plana vitrectomy

结局指标

主要结局

Rate of retinal detachment

时间窗: 12 months

Rate of postoperative retinal detachment. Retinal detachment is diagnosed by the investigator using a dilated fundus (retinal) examination performed at the slit-lamp.

Rate of retroprosthetic membrane formation

时间窗: 12 months

Rate of postoperative retroprosthetic membrane formation behind the backplate of the Boston keratoprosthesis. Retroprosthetic membrane formation is diagnosed by the investigator using an examination of the anterior chamber performed at the slit-lamp.

Rate of glaucoma development

时间窗: 12 months

Rate of development or progression of glaucoma, determined based on intraocular pressure increase of \> 21 mmHg, increase of glaucoma medications, optic nerve excavation progression, or need to undergo glaucoma filtration surgery.

次要结局

  • Proportion of patients with visual acuity better than 20/200(12 months)
  • Change of visual acuity(12 months)
  • Proportion of participants requiring glaucoma surgery(12 months)
  • Time to retroprosthetic membrane formation after surgery(12 months)
  • Proportion of patients with visual field loss of 30% or more(12 months)
  • Rate of Boston keratoprosthesis complications(12 months)
  • Time to retinal detachment after surgery(12 months)
  • Proportion of patients with thinning of the nerve fiber layer(12 months)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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