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临床试验/NCT04408677
NCT04408677终止不适用

Normative Data Collection Study of the Zilia Ocular for the Measurement of Oxygen Saturation in the Retina

Zilia Inc.2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Zilia Inc.
入组人数
33
试验地点
2
主要终点
Normative values of the retinal oxygen saturation at different locations on the retina

研究概览

简要总结

Mainstream oximetry devices use two-wavelength systems to photograph the retina and estimate the oxygen saturation levels in the retinal vessels by comparing light absorption in the blood of the vessels at the selected wavelengths. This method limits the measurements to large retinal vessels, depends heavily on calibration and is non-reproducible across machines. The few numbers of wavelengths used (two) also makes it very susceptible to noise (such as cataract). These shortcomings have largely limited the use of retinal oximetry in clinical practice.

A new technology for retinal oximetry has recently been developed to address issues of dual-wavelength oximeters. Zilia Ocular's oximetry machine uses multi-wavelengths of light to take continuous oxygenation measurements of any targeted regions of the retina. It can measure any area of the retina, including the blood vessels, retinal tissues and the optic nerve head. Its multi-wavelength design also allows it to be less susceptible to noise, more precise and reproducible. This technology has the potential to extend our understanding of retinal pathologies, serve as a new marker for retinal health and even be used as a diagnostic tool to detect retinal injuries before they become visible.

Zilia's novel technology is one of its kind, allowing continuous and accurate measurements of the retina's oxygen saturation. In order to apply this technology to study and investigate retinal diseases, we need to first examine its performance in normal eyes and build a normative database as a reference. Thus, the purpose of the current study is to build a database of baseline oximetry values in healthy Caucasian subjects. The reproducibility of the measurements will also be studied in a subset of patients.

详细描述

STUDY OBJECTIVES

Objectives

Primary:

  1. To measure the oxygen saturation at different locations on the retina (macula, optic nerve head, nasal retina) in order to provide the range of these values in normal eyes.

Secondary:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

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

  • Adult patients above 18 years old, able to consent and willing to undergo mydriasis.
  • Caucasian descent.
  • Intraocular pressure ≤ 21 mmHg.
  • Normal ophthalmological exam.

排除标准

  • Any history of systemic disease, which could affect the eye or oxygen levels (eg: diabetes, severe cardiovascular or respiratory disease).
  • History of epilepsy.
  • Prior intraocular surgery (except cataract surgery).
  • Any history or signs of retinal or optic nerve diseases.
  • Pregnancy, or breastfeeding.
  • Familial history of glaucoma.
  • Ametropia > 6 Diopters.
  • Pupil dilation < 3.6 mm.
  • Current smoker.

结局指标

主要结局

Normative values of the retinal oxygen saturation at different locations on the retina

时间窗: 12-15 months

Oxygen saturation measurement in the eye fundus of healthy subjects from different age groups

次要结局

  • Intraclass correlation coefficient of the measurements on the same patient at the same visit(12-15 months)
  • Percent difference between the measurements of the two eyes.(12-15 months)

研究者

发起方
Zilia Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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