OHTS and EGPS: Glaucoma detection using Confocal Scanning Laser Ophthalmology

OHTS 和 EGPS：使用共焦扫描激光眼科进行青光眼检测

• 批准号: 7689168
• 负责人: LINDA M ZANGWILL
• 金额: $ 16.88万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7689168
• 关键词: Address; Algorithms; Ancillary Study; Collaborations; Data; Data Set; Demographic Factors; Detection; Deterioration; Development; Diagnostic tests; European; Glaucoma; Goals; Image; Individual; Lasers; Measurement; Measures; Modeling; Ocular Hypertension; Ophthalmology; Ophthalmoscopy; Optic Disk; Participant; Patients; Prevention; Primary Open Angle Glaucoma; Process; Protocols documentation; Public Health; Randomized; Randomized Controlled Clinical Trials; Research; Research Design; Retina; Sampling; Sampling Studies; Scanning; Scotoma; Statistical Models; Testing; Time; Visual Fields; compliance behavior; follow-up; hypertension treatment; improved; indexing; model development; ocular hypotensive; public health relevance; stereophotography

DESCRIPTION (provided by applicant): The overall goal of this study is to pool confocal scanning laser ophthalmoscopy (CSLO) data from two large randomized trials, the Ocular Hypertension Treatment Study (OHTS) and the European Glaucoma Prevention Study (EGPS), to improve our ability to predict the development of primary open angle glaucoma (POAG) in ocular hypertensive patients and to enhance our understanding of the effect of ocular hypotensive treatment on optic disc topography. Moreover, the proposed study will use the EGPS dataset to independently test the prediction model developed in the CSLO Ancillary Study to the OHTS and to increase the statistical power for detection of disc features that may be predictive of POAG. OHTS and EGPS share similarities in study design and measurement protocols including ascertainment of POAG, and cause-specific attribution of abnormality. Datasets in a common format have been constructed for each study and merged. Independent analyses by each Coordinating Center have confirmed the OHTS prediction model for the development of POAG. Both studies included CSLO imaging on a subset of their participants with similar image acquisition and processing protocols. Specifically, the CSLO Ancillary Study to the OHTS has analyzable good quality CSLO data on 439 participants and the EGPS has analyzable CSLO data on 470 participants. This proposal will merge the CSLO data with the existing merged EGPS and OHTS dataset and will include CSLO data from 909 ocular hypertensive participants with a median follow-up of more than 4 years and a total of 84 POAG endpoints. The merged sample, the largest longitudinal dataset of ocular hypertensive subjects with CSLO imaging will provide statistical power to test hypotheses that might not be possible with one dataset alone. This collaboration will not interfere with each study's ability to analyze its own dataset. The Specific Aims are: 1) Improving Prediction Models using Baseline HRT indices. To develop statistical models that use baseline Heidelberg Retina Tomograph (HRT) topographic optic disc parameters to predict development of a POAG endpoint detected by reproducible visual field abnormalities and/or optic disc deterioration. 2) Improving Prediction Models Using Baseline and Follow-up HRT indices. To determine the predictive accuracy of baseline HRT indices or change in these indices during follow-up for developing POAG. 3) Predicting the first sign of glaucoma. To evaluate whether baseline HRT alone or in combination with other baseline ocular and demographic factors are predictive of whether a POAG endpoint is first detected by visual field changes or optic disc changes. 4) Comparison of stereophotography and confocal scanning laser ophthalmoscopy for detecting glaucomatous change over time. To compare the detection of optic disc changes using HRT automated change detection algorithms to expert qualitative assessment of stereophotographs. PUBLIC HEALTH RELEVANCE: The overall goal of this study is to pool confocal scanning laser ophthalmoscopy (CSLO) data from two large randomized trials, the Ocular Hypertension Treatment Study (OHTS) and the European Glaucoma Prevention Study (EGPS), to improve our ability to predict the development of primary open angle glaucoma (POAG) in ocular hypertensive patients and to enhance our understanding of the effect of ocular hypotensive treatment on optic disc topography. Because CSLO measures are reproducible, objective, quantitative, non-invasive, and require minimal patient cooperation, their potential as an early diagnostic test for POAG has broad public health significance. The combined EGPS/OHTS sample has more than 909 randomized participants with longitudinal CSLO measurements making it the largest sample of prospectively obtained CSLO measurements in ocular hypertensive individuals.

描述（申请人提供）：本研究的总体目标是汇总来自两项大型随机试验（高眼压治疗研究（OHTS）和欧洲青光眼预防研究（EGPS））的共焦扫描激光检眼镜检查（CSLO）数据，提高我们预测原发性开角型青光眼（POAG）发展的能力目的：探讨高眼压症患者眼压控制的临床意义，并进一步了解眼压控制对视盘地形图的影响。此外，拟议的研究将使用EGPS数据集独立测试CSLO辅助研究中开发的OHTS预测模型，并增加检测可能预测POAG的椎间盘特征的统计功效。OHTS和EGPS在研究设计和测量方案上有相似之处，包括POAG的确定和异常的原因特异性归因。为每项研究建立了通用格式的数据集，并进行了合并。每个协调中心的独立分析证实了POAG发展的OHTS预测模型。两项研究均包括使用相似图像采集和处理协议对其参与者子集进行CSL 0成像。具体而言，OHTS的CSLO辅助研究有439名参与者的可分析高质量CSLO数据，EGPS有470名参与者的可分析CSLO数据。该提案将合并CSLO数据与现有合并EGPS和OHTS数据集，并将包括来自909名高眼压受试者的CSLO数据，中位随访时间超过4年，共有84个POAG终点。合并样本，CSL 0成像的高眼压受试者的最大纵向数据集，将提供统计功效来检验假设，而这些假设可能无法单独使用一个数据集。这种合作不会干扰每个研究分析自己数据集的能力。具体目标是：1）使用基线HRT指标改进预测模型。开发使用基线海德堡视网膜断层扫描仪（HRT）视盘地形图参数的统计模型，以预测通过可重现视野异常和/或视盘退化检测到的POAG终点的发展。2)使用基线和随访HRT指数改进预测模型。确定基线HRT指标或随访期间这些指标变化对POAG发展的预测准确性。3)青光眼的早期症状有哪些评价基线HRT单独或与其他基线眼部和人口统计学因素联合是否可预测POAG终点是否首先通过视野变化或视盘变化检测到。4)立体摄影术与共焦扫描激光检眼镜检测青光眼随时间变化的比较。比较使用HRT自动变化检测算法检测视盘变化与立体摄影的专家定性评估。公共卫生关系：本研究的总体目标是汇总来自两项大型随机试验（高眼压治疗研究（OHTS）和欧洲青光眼预防研究（EGPS））的共焦扫描激光检眼镜检查（CSLO）数据，提高我们预测原发性开角型青光眼（POAG）发展的能力目的：探讨高眼压症患者眼压控制的临床意义，并进一步了解眼压控制对视盘地形图的影响。由于CSL 0测量是可重复的，客观的，定量的，非侵入性的，并且需要最少的患者合作，它们作为POAG的早期诊断测试的潜力具有广泛的公共卫生意义。合并的EGPS/OHTS样本有超过909名随机化参与者进行了纵向CSL 0测量，使其成为高眼压患者前瞻性获得的CSL 0测量的最大样本。