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临床试验/NCT01162356
NCT01162356已完成不适用

A Prospective Analysis of Nerve Fiber Layer and Macular Changes After Pars Plana Vitrectomy

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Nerve fiber layer and macular changes after vitrectomy

研究概览

简要总结

Since the introduction of vitrectomy in 1971, this procedure has become the third most frequently performed ophthalmic surgery. Approximately 225,000 vitrectomies are performed annually in the United States and indications continue to expand. Known long-term complications of vitrectomy are relatively few and include retinal detachment and cataract formation. Although much has been written in the literature concerning acute rises in intraocular pressure (IOP) in the immediate postoperative period, there is surprisingly little information on long term IOP outcomes after vitrectomy. A recent report by Chang given at the LXII (62) Edward Jackson Memorial Lecture hypothesized a causal relationship between vitrectomy and open-angle glaucoma (OAG) via oxidative stress exacerbated by removal of the crystalline lens. A second report by Luk and colleagues reported similar conclusions in a modified cohort. Both studies, were retrospective in nature and did not perform baseline evaluations to exclude pre-existing glaucoma. Furthermore neither study accounted for natural history. Finally, our analysis has not reproduced similar results.

The primary purpose of this study is to analyze the full spectrum of optic nerve and macular changes between vitrectomized study eyes and their non-vitrectomized fellow eyes to control for natural history. Baseline evaluations will include examination by fellowship trained retina and glaucoma specialists, fundus photography, autofluorescence, optical coherence tomography (macula and optic nerve) and automated visual field testing. At 3 month then annually for 5 years after vitrectomy surgery, the cohort will undergo similar evaluation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Able to consent and comply for the duration of the study and imaging studies
  • Media clarity sufficient for imaging studies
  • No previous treatment or surgery that might confound study results in the study or fellow eye
  • Pars plana vitrectomy (PPV) indicated for epiretinal membrane (ERM), macular hole (MH), vitreo-macular traction (VMT), and vitreous hemorrhage (VH)

排除标准

  • Unable to consent and/or comply for the duration of the study and imaging studies
  • History of the following conditions: Glaucoma or associated conditions, visual field defects, uveitis, age-related macular degeneration (ARMD), prior PPV for retinal detachment, retained lens or dislocated intraocular lens
  • Contralateral eye status post PPV or with advanced eye disease serious enough to warrant future PPV - Contralateral eye with condition that may result in choroidal neovascular membrane

结局指标

主要结局

Nerve fiber layer and macular changes after vitrectomy

时间窗: 3 month and annually for 5 years after surgery

To determine the incidence of nerve fiber layer (NFL) and macular changes after pars plana vitrectomy, characterize their extent and quality, and determine pre-disposing risk factors.

次要结局

  • Visual field defects(3 month and annually for 5 years after surgery)
  • Open-angle glaucoma(3 month and annually for 5 years after surgery)

研究者

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

Stephen J. Kim, MD

Associate Professor of Ophthalmology

Vanderbilt University

研究点 (1)

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