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临床试验/NCT02441777
NCT02441777尚未招募不适用

Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
2
主要终点
Average nerve fiber layer (NFL) birefringence

研究概览

简要总结

The aim of this pilot study is to assess the ability of a new polarization sensitive optical coherence tomography system to obtain high-quality images of retinal birefringence.

详细描述

Glaucoma is the second leading cause of blindness in the world. The current clinical standard-of-care procedure to diagnose glaucoma is visual field testing with disc photography. Visual field testing is subjective both in the patient's feedback and the physician's interpretation of this feedback, and disc photography requires a physician's subjective interpretation. As a result, it is estimated that current methods can diagnose glaucoma only after 40% of the nerve fiber layer (NFL) has been lost. Since glaucoma leads to significant changes in both NFL thickness and NFL optical birefringence, non-invasive imaging of these properties could potentially enable diagnosis of glaucoma prior to changes in vision. Optical Coherence Tomography (OCT) is routinely used in retinal imaging, and its ability to detect changes in NFL health is being actively studied. To detect NFL optical birefringence, a specialized variation of OCT termed polarization sensitive OCT (PS-OCT) is required. Because of high noise in PS-OCT images, prior studies have been unable to detect NFL changes in birefringence.

We have recently developed new methods for performing highly sensitive polarization-sensitive OCT. These changes are algorithmic in nature, and use the same optical wavelengths and powers as clinically deployed OCT retinal imaging instruments. In benchtop studies, these algorithmic changes improve the signal-to-noise ratio (SNR) of PS-OCT images. We propose to conduct a pilot study in normal, healthy subjects to evaluate if these changes improve the SNR of NFL birefringence images.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female subjects between the ages of 18-85 years
  • Healthy normal subjects with no significant eye disease, except for mild cataracts
  • Subjects with clear enough cornea or clear enough media to permit imaging
  • Subjects with refractive error between -5.00 sph to +5.00 sph

排除标准

  • Subjects who have occludable narrow angles (without a patent peripheral iridotomy) or any other ocular or systemic pathology, which precludes safe dilation
  • Subjects whose eyes have been dilated for over 6 hours will not be eligible for imaging.
  • Subjects who do not or cannot understand the instructions for the PS-OCT imaging
  • Subjects who are pregnant and/or breastfeeding. Date of last menstrual cycle will also be included.

结局指标

主要结局

Average nerve fiber layer (NFL) birefringence

时间窗: At time of imaging

Measured birefringence values will be compared to normative values from literature

次要结局

未报告次要终点

研究者

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

Benjamin Vakoc

Assistant Professor

Massachusetts General Hospital

研究点 (2)

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