跳至主要内容
临床试验/NCT04647929
NCT04647929撤回不适用

Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas

University of Zurich0 个研究点开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Efficacy 1

研究概览

简要总结

Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients as second surgery after failed trabeculotomy or goniotomy.

详细描述

Glaucoma is a chronic, progressive disease, leading to blindness if untreated or insufficiently treated. It is characterized by a loss of optic nerve fiber and a glaucomatous optic disc excavation and, a corresponding pattern of visual field loss. Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). PCG and DG are treated surgically, either by goniotomy or by trabeculotomy as first approach, and not with topical hypotensive medications. Whenever these procedures have failed, the subsequent surgical procedure is usually trabeculectomy with Mitomycin C or the implantation of a glaucoma drainage device. However, there is a lack of evidence regarding the "optimal" surgical approach after failed goniotomy/trabeculotomy. Optimal treatment in this young group of patients with a long life expectancy is crucial to prevent blindness, allow them to participate in a "normal" school and work environment, and to minimize disease burdens for these patients and their families as well as to minimize costs for society. Consequently, there is the desire to find a procedure with a superior success rate and even fewer or less severe complications compared to trabeculectomy. Recently, the Santen PRESERFLO was introduced. The results proved fewer complications and comparable efficacy to trabeculectomy, according results presented at scientific meetings. Yet, there are no published studies to compare the both procedures. The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Minors younger than 18 years of age with a diagnosis of Primary Congenital Glaucoma (PCG) or Developmental Glaucoma (DG) will be included
  • participants must have had a failed trabeculotomy or goniotomy (once or twice) or one 360° trabeculotomy.

排除标准

  • Individuals with eye pathologies other than glaucoma or, who underwent intraocular surgery within the last 6 months will not be included.
  • patients who will not be willing to proceed with the entire follow-up of 6 months, or whose legal representative did not sign the informed consent will not be enrolled.

结局指标

主要结局

Efficacy 1

时间窗: at 6months compared to baseline (i.e. preop)

Change in Goldmann-applanation intraocular pressure (IOP) in mmHg

Efficacy 2

时间窗: at 6months compared to baseline (i.e. preop)

Change in the number of drug classes of intraocular pressure (IOP) lowering medications

Complication rate

时间窗: within 6 months from surgery

rate of intraoperative and postoperative complications (safety)

次要结局

  • Exome Sequencing(at baseline)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Comparison of Surgical Treatment Options for Primary... | 临床试验