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临床试验/NCT07531667
NCT07531667已完成不适用

Use of Fresnel Prism in Low Vision Patients With Homonymous Hemianopia Defect in Cipto Mangunkusumo Hospital

Indonesia University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Visual Fied

研究概览

简要总结

Background: Homonymous hemianopia is a visual field defect that causes functional disabilities, such as decreased self-confidence, limited mobility, and increased risk of falls. Studies related to the effectiveness and comfort of Fresnel prisms, especially in the Indonesian population are limited.

Objective: To evaluate the effectiveness and comfort level of Fresnel prisms in expanding visual field in an Indonesian patient population with homonymous hemianopia.

详细描述

: Fresnel prisms with a power of 40∆ were fitted to the patient's spectacles for two weeks. Visual field parameters were analysed using the Humphrey Field Analyzer with the SITA 24-2 algorithm, while the Pelli-Robson and ETDRS charts were used to assess contrast sensitivity and visual acuity, respectively. After visual assessment, comfort was quantitatively assessed using a comfort scale.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • subjects with a diagnosis of partial or complete homonymous hemianopia based on the results of the Humphrey perimetry examination;
  • age 18 years or older;
  • corrected visual acuity of 6/18 or better; and
  • willing to give consent for this study and consistently follow the rehabilitation process.

排除标准

  • ocular motility disorders; the primary position of the eyeball was not orthophoric; and
  • walking disorders that resulted in poor fixation of glasses.

研究组 & 干预措施

Fresnel prism

Experimental

The Fresnel prism chosen was of 40∆ power (the largest size available) with the aim of the largest visual field expansion, which was 20 degrees that the patient felt during environmental orientation and mobilisation. Fresnel prism fitting was performed using the patient's spectacles (if wearing spectacles) or plano glasses provided by the researcher. The patient was then asked to practice scanning before being asked to wear the Fresnel prism for 5.5 hours daily for two weeks. Patients were given a wear sheet to evaluate the duration of wear in a day

干预措施: Fresnel prism (Device)

结局指标

主要结局

Visual Fied

时间窗: 2 weeks

Mean Deviation (dB) Pattern Standard deviation (dB) Visual field index (%)

次要结局

  • TPDK(2 weeks)
  • Contrast sensitivity(2 weeks)

研究者

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

dr. Tri Rahayu, SpM(K), FIACLE

MD

Indonesia University

研究点 (1)

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