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Extent of ILM Removal and Its Impact on Outcomes of MH Surgery

2016年1月5日 更新者:Samsung Medical Center

Extent of Internal Limiting Membrane Removal and Its Impact on Outcomes of Macular Hole Surgery

Eligible patients who were scheduled for surgery for idiopathic macular hole (MH) were equally randomized to small extent group or large extent group depending on the extent of internal limiting membrane (ILM) to be removed. The ILM was peeled in round shape with the radius of either 0.75-disc diameter or 1.5-disc diameter according to the group. The primary analysis was conducted to identify the difference of functional and anatomical outcomes between the two groups. Subsequent analysis was performed to reveal the relationship between the functional and anatomical outcomes.

研究概览

详细说明

This randomized clinical trial was performed at a single center. Patients who were scheduled for surgery for idiopathic macular hole (MH) were enrolled. Eligible patients were equally randomized to small extent group or large extent group depending on the extent of ILM to be removed. Random numbers were generated through computerized block-randomization.

A standard 3-port pars plana vitrectomy was performed by a single surgeon using 23-gauge vitrectomy system, with a 1-step scleral tunnel incision. After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of indocyanine green dye. The ILM was peeled in round shape with the radius of either 0.75-disc diameter or 1.5-disc diameter centering at the center of the MH according to the pre-assigned group. This was followed by a complete fluid-gas exchange, and all patients were encouraged to maintain a face-down position for at least 5 days postoperatively.

Postoperative measurements of BCVA and M-score were conducted at 2- and 6-month follow-up visits by independent masked observers. The first postoperative SD-OCT scanning was usually conducted at 1 to 2 weeks after operation according to the intraocular gas status. Then, OCT scans were conducted at follow-up visits 2, and 6 months postoperatively. The same experienced examiner conducted all the OCT scans on all subjects.

Comparison of anatomical closure, BCVA, M-score, Δ BCVA, and Δ M-score were primarily performed between the two groups. Then, the parameters measured from OCT scans with changes in ETDRS visual acuity and M-score were analyzed.

研究类型

介入性

注册 (实际的)

65

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Seoul、大韩民国、06315
        • Samsung Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • idiopathic macular hole

Exclusion Criteria:

  • macular hole associated with other causative diseases

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Small Extent Group (SG)
Patients who were scheduled for surgery for idiopathic macular hole were randomly assigned to the SG. The small-extent peeling was performed in SG.
The internal limiting membrane was peeled in round shape with the radius of 0.75-disc diameter radius (1.5-disc diameter in total) centering at the center of the macular hole.
有源比较器:Large Extent Group (LG)
Patients who were scheduled for surgery for idiopathic macular hole were randomly assigned to the LG. The large-extent peeling was performed in LG.
The internal limiting membrane was peeled in round shape with the radius of 1.5-disc diameter radius (3.0-disc diameter in total) centering at the center of the macular hole.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Degree of foveal elongation
大体时间:postoperative 6months
postoperative 6months

次要结果测量

结果测量
大体时间
metamorphopsia
大体时间:6months
6months

其他结果措施

结果测量
大体时间
视力变化
大体时间:6个月
6个月

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Kunho Bae, MD、Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年7月1日

初级完成 (实际的)

2015年10月1日

研究完成 (实际的)

2015年11月1日

研究注册日期

首次提交

2013年12月9日

首先提交符合 QC 标准的

2013年12月11日

首次发布 (估计)

2013年12月12日

研究记录更新

最后更新发布 (估计)

2016年1月7日

上次提交的符合 QC 标准的更新

2016年1月5日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2013-07-083

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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