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临床试验/NCT03037268
NCT03037268撤回不适用

Quality and Diagnostic Utility of Mydriatic Fundus Plenoptic Photography: The Plenoptic Ophthalmoscopy Reliability Trial

Wills Eye1 个研究点 分布在 1 个国家开始时间: 2018年12月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Image quality

研究概览

简要总结

  1. Establish the quality of fundus images produced by plenoptic ophthalmoscopy using the grading system proposed and utilized in the Fundus Photography versus Ophthalmoscopy Trials Outcomes in the Emergency Department (FOTO-ED) Study.
  2. Determine diagnostic utility of plenoptic ophthalmoscopy images by comparing masked image reviewers' quality measurements and findings to images obtained with a commercially available ocular fundus camera and documented exam findings

详细描述

Visualization of the ocular fundus is considered an essential part of the physical examination, as abnormalities of the optic nerve, retinal vessels, and macula can reveal underlying systemic diseases and explain the etiology of visual complaints.

The Fundus Photography versus Ophthalmoscopy Trials Outcomes in the Emergency Department (FOTO-ED) Study demonstrated that only 14% of patients with complaints and conditions in which fundus examination is considered important had direct ophthalmoscopy performed by an ED physician .Greater than 80% of previously unknown fundus findings relevant to ED patient management were missed by ED physicians, but were identified by nonmydriatic digital fundus photography. Several of these cases resulted in recall of a discharged patient back to the ED for hospital admission once diagnostic fundus photos were reviewed.

In the search for an alternative to improve ease of use and fundus image quality, plenoptic technology provides a promising option for portable fundus imaging. Plenoptic, or light field, imaging has recently been introduced commercially with the release of the Lytro Plenoptic Camera (Mountain View, CA, USA). Utilizing an array of microlenses, the Lytro camera captures all available light in a scene from multiple vectors. By dividing up a scene as a whole with many individual microlenses, images can be refocused in post processing after acquisition, sharp focus can be attained in low light situations, and stereo images with perspective shifting can be attained.

To date there have been no published quantitative descriptions of the quality and reliability of plenoptic ophthalmoscopy using a commercially available, portable light field camera. Initial work from a pilot study using animal and human eyes was published in 2016. The purpose of the proposed prospective, cross sectional imaging study is to compare standard mydriatic fundus photography to a second generation camera developed with a Lytro plenoptic camera and customized light source, specifically analyzing diagnostic utility/sensitivity of detecting retinal pathology and overall image quality. If the image quality outcomes of the investigators proposed study are similar to those of the nonmydriatic fundus camera, the implications for physicians and the potential applications to ophthalmology related telemedicine are significant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • With and without visually significant posterior retinal or optic nerve pathology,
  • Pregnant women if already dilated for reason other than study participation.

排除标准

  • Children,
  • Prisoners,
  • Poor view of posterior pole due to anterior segment pathology,
  • Poor view of posterior pole due to posterior media opacities that necessitate use of B-scan ultrasound to evaluate posterior pole.

结局指标

主要结局

Image quality

时间窗: through study completion, an average of 1 year

Image quality grade (1 - 5, with 1 being excellent and 5 being not diagnostically useful)

Detection rate of "critical" retinal findings

时间窗: through study completion, an average of 1 year

Sensitivity (%) of detection of "critical" retinal findings with plenoptic ophthalmoscopy. Critical retinal findings include retinal detachment, retinal vascular sheathing, retinal hemorrhage, retinal whitening, optic disc edema, optic disc pallor, optic disc cupping (\> 0.5 cup-to disc ratio)

次要结局

未报告次要终点

研究者

发起方
Wills Eye
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Hsu, MD

Dr., MD

Wills Eye

研究点 (1)

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