使用综合测序的眼部病原体和转录组研究 (OPTICS)

有源比较器：护理标准

参加试验并随机分配到标准护理 (SOC) 组的患者将接受标准护理测试。

诊断测试：护理标准 (SOC)

SOC 包括任何可用的诊断测试，例如革兰氏染色、培养、PCR，这些被认为是基于临床发现的适当测试。

实验性的：材料数据表

参加试验并随机分配到 MDS 组的患者将接受标准护理测试和 MDS 测试。

设备：宏基因组深度测序 (MDS)

MDS 是一种基于 RNA-seq 的眼液或组织测试，用于识别潜在的传染性病原体，包括细菌、真菌、寄生虫以及 DNA 和 RNA 病毒。

Clinical Improvement 2-step Decrease in the Level of Inflammation or Decrease to Grade 0; Inflammatory Retinal/Choroidal Lesions Reducing in Size; 20% Improvement of CST on Optical Coherence Tomography, a > 10- Letter Improvement in Visual Acuity,

Dichotomous variable (Y/N) as assessed by a masked evaluator

Appropriate Therapy

Dichotomous variable (Y/N) as determined by an independent expert panel

Provider Certainty of Belief

Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%, 0% signifying uncertain and 100% signifying certain)

Patient Quality of Life

As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)

Comparative Sensitivity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis

Latent Class Analysis (LCA) was used to estimate the sensitivity of three diagnostic approaches: (1) clinical diagnosis by the treating physician at presentation, (2) conventional diagnostics, and (3) MDS.

LCA was performed on all randomized participants with infection status, evaluating the diagnostic performance of treating physicians, conventional diagnostics, and MDS. A total of 100 participants were enrolled in Phase l of the OPTICS trial.

Comparative Specificity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis

Latent Class Analysis (LCA) was used to estimate the specificity of three diagnostic approaches: (1) clinical diagnosis by the treating physician at presentation, (2) conventional diagnostics, and (3) MDS.

LCA was performed on all randomized participants with infection status, evaluating the diagnostic performance of treating physicians, conventional diagnostics, and MDS. A total of 100 participants were enrolled in Phase l of the OPTICS trial.