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临床试验/NCT03531671
NCT03531671已完成不适用

The Future of Cataract Assessment: Investigation of the Utility of a Novel Binocular OCT System for Clinical Application

Moorfields Eye Hospital NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Feasibility

研究概览

简要总结

The purpose of the study is to investigate if a novel instrument called a Binocular Optical Coherence Tomographer (OCT) may resolve many of the issues with the assessment of patients with cataract.

详细描述

Cataract is the second leading cause of blindness in western Europe but the leading cause of blindness in the developing world and both central and eastern Europe. The most common cause of cataract is age. A number of clinical assessments are required to assess the status and suitability of each patient for cataract surgery. Currently, these procedures are performed in an inefficient manner with the patient having to move to different clinical areas to access often large instruments that are costly to both purchase and maintain. Such an inefficient patient pathway has been identified as a factor that can markedly increase the cost of outpatient appointments, extend waiting times, and crucially lead to a reduction in patient satisfaction. A novel instrument that offers a solution to such problems is the recently developed Binocular Optical Coherence Tomographer. Binocular-OCT is capable of non-invasively imaging the whole-eye in a potentially small, inexpensive and portable device and is also capable of capturing images from both eyes in the same session without the need for assistance from a trained technician. The Binocular-OCT has the capability to perform the functions of many clinical tools in a single instrument. Of particular relevance to the assessment of the patient with cataract is the ability to capture high resolution images of the anterior eye and crystalline lens with swept-source OCT technology. In this study, the proposed advantages of binocular OCT system will be assessed for the management of cataract.

This research is important, to not only improve cataract assessment and optomise surgical outcomes, but it is also vital to establish sensitive measures of lens quality to determine tools to aid trails attempting to retard the progression of cataract.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Presence of cataract
  • Male or female, aged 18 years or older
  • Ability to understand nature/purpose of the study and to provide informed consent
  • Ability to undergo binocular OCT imaging
  • Ability to follow instructions and complete the study
  • Ability to speak English

排除标准

  • - Hearing impairment sufficient to interfere with hearing instructions
  • Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
  • Any cases where the globe has been affected by trauma, etc.
  • Traumatic aetiologies of cataract

结局指标

主要结局

Feasibility

时间窗: 18 Months

Investigate the feasibility of the Binocular-OCT to produce accurate biometric measurements of the eye, via calculation of quantitative cataract density and localisation index from the binocular-OCT image of the lens.

次要结局

  • Post-Operative Measurements(18 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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