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临床试验/NCT03823092
NCT03823092Unknown不适用

Polarization Perception in Health and Disease. Testing a New Sight Test: The TaNSiT Study

South Warwickshire NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年11月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
polarization sensitivity

研究概览

简要总结

A study to assess the utility of human polarization pattern perception for the detection, diagnosis and monitoring of eye disease

详细描述

The recently described high sensitivity of the human eye to differentiate small angular differences in linear polarization and evidence supporting its macular origin (Misson, Anderson; 2017) suggests that human polarization sensitivity might be a useful diagnostic tool for macular disease. This augments a previous study in which we demonstrated the ability of the human visual system to detect isochromatic isoluminant polarization modulated pattern stimuli (Misson et al 2015).

This is an exploratory 'proof-of-concept' study to determine the clinical value of polarization pattern perception, PPP, in health and disease. We further propose that PPP might be valuable for the diagnosis, monitoring and early detection of macular disease. The latter includes common blinding conditions such as age related macular degeneration and diabetic retinopathy. It is also intended to investigate the effect of cataracts and cataract surgery on PPP: cataract surgery modifies the optics of the eye so might also modify PPP.

PPP is measured using a modification of the methodology described in (Misson et al 2015) and (Misson, Anderson; 2017) whereby polarization modulated patterns are presented on a modified LCD display. The observer's task is to report if they see an image and to describe the image. Images comprise simple patterns or traditional optotypes. A standard set of images are presented in pseudorandom order and the response recorded. A total score, the polarization pattern perception score PPP is then determined from the number of images seen/identified. A more refined metric, the polarization visual acuity pVA, will be derived from the response to the optotype stimuli. These data are then compared to conventional tests of visual structure and function including logMAR visual acuity, ocular examination and OCT scan data.

The study in anticipated to comprise:

Phase 1. Normative Evaluation: observational prospective cross-sectional.. A preliminary normative study will be undertaken on staff members. The aim is to quantify normative values in preparation for the clinical studies.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • willing and able to provide informed consent

排除标准

  • unwilling or unable to provide informed consent
  • individuals wishing to exit the study

结局指标

主要结局

polarization sensitivity

时间窗: 18 month

determine and compare polarization sensitivity between groups

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

Gary Misson

Consultant ophthalmologist

South Warwickshire NHS Foundation Trust

研究点 (1)

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