跳至主要内容
临床试验/NCT00994227
NCT00994227已完成不适用

Clinicopathologic Findings for Macular Disease

Hallym University Medical Center2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2009年5月最近更新:
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
60
试验地点
2
主要终点
spectral domain optical coherence tomography

研究概览

简要总结

this study is to analyze and compare the ultrastructure of the retinal and vitreous plane of the epiretinal membrane and internal limiting membrane removed during macular surgery and to evaluate relation between the ultrastructure of the epiretinal membrane and internal limiting membrane and surgical outcomes.

详细描述

prospective, interventional study and includes patients who underwent vitrectomy,peeling of an epiretinal membrane and internal limiting membrane excision with or without intraoperative intraocular ICG injection.

Excised specimens were placed on a Millipore filter, fixed in a paraformaldehyde solution, and examined by light and transmission electron microscopy. Ultrathin sections were stained with uranyl acetate-lead citrate and inspected in a Zeiss EM electron microscope. The assessment was done in a blinded, masked fashion so that the clinicians who reviewed the histologic specimens

研究设计

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

入排标准

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

入选标准

  • patients who underwent vitrectomy,peeling of an idiopathic MEM and ILM excision with or without intraoperative intraocular ICG injectio

排除标准

  • the presence of macular hole or lamellar macular hole previous vitreoretinal surgery the presence of any other macular pathologic features potentially interfering with histologic results (such as diabetic retinopathy or age-related macular degeneration).

研究组 & 干预措施

surgery

Experimental

干预措施: vitrectomy for macular disease (Procedure)

结局指标

主要结局

spectral domain optical coherence tomography

时间窗: baseline, 1week, 1month, 3 month

The central 1mm subfield thickness the average macular thickness the inner nuclear layer thickness outer nuclear layer thickness outer plexiform layer thickness photoreceptor integrity ILM map RPE map

best corrected visual acuity

时间窗: baseline, 1 month, 3 months

logMAR

次要结局

  • electron microscopy finding of internal limiting membrane(during operation)
  • visual field(baseline, postoperative 1 months, 3 months)
  • preferential hyperacuity perimeter(baseline, postoperative 1 months, 3 months)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验