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临床试验/NCT00609687
NCT00609687已完成不适用

Diagnostic Yield of Vitreous Biopsy in Sarcoid Uveitis

Duke University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2007年1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
150
试验地点
2
主要终点
To determine the diagnostic yield of vitreous biopsy in patients with suspected sarcoid uveitis

研究概览

简要总结

The usefulness of diagnostic vitrectomy in patients with suspected sarcoidosis with posterior segment involvement (in whom a diagnosis cannot be determined by conventional methods) has not been well described. We hypothesized that diagnostic vitrectomy would help establish the diagnosis in these challenging cases. Herein, we evaluated the diagnostic yield of vitreous biopsy in patients with suspected sarcoidosis-associated uveitis that affected the posterior segment.This is a retrospective interventional case series. Cases of intermediate, posterior or panuveitis that could not be characterized by clinical examination, ancillary, and laboratory tests were considered for diagnostic pars plana vitrectomy. Retrospective chart review was conducted on consecutive eyes that underwent diagnostic, or diagnostic and therapeutic vitrectomy by a single surgeon from January 1989 to June 2006.

详细描述

We obtained approval to conduct this non-comparative, interventional, retrospective case series from the Duke University Institutional Review Board. We used an established database of patients with uveitis and the operative reports from a single surgeon (GJJ) to identify all consecutive patients who underwent diagnostic pars plana vitrectomy from January 1989 to June 2006. We excluded patients with acute postoperative or traumatic endophthalmitis from this study. Cases were included if intraocular vitreous specimens were obtained for diagnostic testing. After identifying 150 patients, we reviewed the medical records of these individuals as previously described.

Patient demographic data and clinical history were recorded at the time of initial visit. A complete ophthalmic history and examination were performed by a single examiner (GJJ). The examination included slit-lamp biomicroscopy and dilated fundus examination with indirect ophthalmoscopy. Anterior segment inflammation was graded using the system described by Hogan and colleagues. The system previously described by Nussenblatt et.al. was used to grade vitreous opacity. Fluorescein angiography, optical coherence tomography, and ultrasonography were performed as indicated. A differential diagnosis was compiled for each case, based on clinic findings. Additional laboratory tests were ordered depending on the constellation of clinical history, exam findings, and results of previous ancillary testing. Anti-inflammatory therapy was initiated in an empiric or diagnosis-specific manner, and the clinical response was followed carefully.

Diagnostic vitrectomy was performed on eyes with intermediate, posterior, or panuveitis in which an etiology could not be characterized by clinical examination, laboratory, and/or ancillary testing. In addition, diagnostic vitrectomy was performed on eyes that did not adequately respond to empirical therapy, or those in which intraocular malignancy or infection was suspected. Therapeutic vitrectomy was performed in conjunction with diagnostic vitrectomy when clinically indicated, for example to repair retinal detachment, to remove epiretinal membranes, to decrease vitreous opacity, or to insert an intraocular sustained drug-delivery implant.

In this study, vitreous samples were collected in the operating room using a standardized technique which has been previously reported. Briefly, three-port, 20-gauge pars plana vitrectomy instrumentation was utilized. An infusion line was inserted into one sclerotomy and secured to the globe. A second sclerotomy was made, and a fiberoptic light pipe was immediately inserted to minimize vitreous egress. A third sclerotomy was created, and the vitreous cutter was inserted. To obtain an undiluted vitreous sample, the vitreous was cut mechanically with the vitreous cutter, while the assistant surgeon simultaneously manually aspirated the vitreous. The tip of the vitreous cutter was viewed at all times with the wide-field viewing system during the procedure. After sufficient undiluted sample was obtained, infusion fluid was allowed to enter the eye and a diluted vitreous sample was obtained in a similar manner. The samples were personally carried to the clinical laboratories by the operating surgeon. Vitreous fluid analysis was guided by clinical suspicion based on the pre-operative differential diagnosis and the intraoperative posterior segment appearance. Cytopathology was used to identify granulomatous inflammation or tumor cells. A thin-prep was prepared, processed through a membrane filter apparatus (Millipore Corp, Bedford, MA) and then stained with Papanicolaou stain. Gram stain, KOH preparation and culture were used to diagnose intraocular infection. Where appropriate, instructions were given to the clinical laboratory for specific sample processing (e.g., suspected slow-growing bacterium, such as Propionibacterium acnes or suspected fungal infection). Genomic amplification by polymerase chain reaction (PCR) was performed at the University of Colorado (Boulder, CO), or Texas Children's Hospital (Houston, TX) to test for the presence of Herpes simplex virus, Herpes zoster virus, and cytomegalovirus. PCR was performed for Toxoplasma gondii at the Palo Alto Medical Foundation (Palo Alto, CA) as previously described. Toxocara canis antibody levels were detected by enzyme-linked immunosorbent assay (ELISA) at the Centers for Disease Control and Prevention (Atlanta, GA). For Toxoplasma gondii and Toxocara canis, simultaneous serum samples were also collected and sent to the respective laboratories.

The final diagnosis was based upon the results of the directed diagnostic testing of the vitreous sample. A positive diagnostic vitrectomy result was based upon the identification of a specific etiologic agent through the testing modalities previously described. Sarcoidosis is a diagnosis of exclusion without a known etiologic agent. There are no definitive laboratory tests that unequivocally confirm a diagnosis of sarcoid. Therefore, a diagnostic specimen was deemed positive for sarcoid-related inflammation if the following criteria were satisfied: 1) if all other vitreous testing was negative 2) if the clinical features were such that sarcoidosis was included in the differential diagnosis based on pre-operative clinical appearance, and 3) if the cytopathology specimen was consistent with a pattern of sarcoid-related inflammation such as non-caseating granuloma formation, as established by the cytopathologist.

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

性别
All
接受健康志愿者

入选标准

  • Cases were included if intraocular vitreous specimens were obtained for diagnostic testing.

排除标准

  • Patients with acute postoperative or traumatic endophthalmitis from this study were excluded.

结局指标

主要结局

To determine the diagnostic yield of vitreous biopsy in patients with suspected sarcoid uveitis

时间窗: January 1989 to June 2006

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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