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临床试验/NCT03848663
NCT03848663招募中不适用

Remapping the Visual Field to Aid Reading With Central Scotomas

University of Minnesota1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年2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
招募中
入组人数
108
试验地点
1
主要终点
Reading Speed for Natural Text Samples

研究概览

简要总结

Reading performance in patients with Central Vision Loss and age matched controls with artificial scotomas will be measured with and without different kinds of remapping of missing text to different parts of the visual field.

详细描述

Following initial characterization of their visual field loss, the participant's performance in reading tasks will be measured with and without remapping. Tasks will include reading groups of random letters, words, simple sentences, and "natural" text from the environment (taken from phone apps, signage, etc). Different kinds of remappings will be used by participants, including traditional and personalized remapping. For control observers, differently shaped artificial scotomas will be used.

Participants interested in the study will be brought in for an initial visit. All participants will be administered the MMSE. Observers who pass the criteria for the study will then have the remainder of the procedures described to them verbally prior to undergoing the remainder of the consent process (see below). Participants will then undergo a standard exam at the UMN eye clinic, if they have not had one within the last month.

Participants will then have their scotomas mapped using a microperimeter housed in the psychology department to give size and shape information. Additional perimetry may also be conducted using either of the two displays (either HMD or desk mounted computer monitor) we have developed. Here, patients will be asked to fixate at a spot on screen and identify visual stimuli presented at different regions of the screen. The size and locations of visual stimuli patients were unable to identify will provide the size and location of the scotoma. Another additional manual perimetry protocol may be conducted as well. This would involve asking subjects to fixate at the center of a tangent screen, and asking them to identify dots temporarily presented on the screen by the researcher using a laser pointer. The locations of dots that patients are unable to identify will provide the size and location of the scotoma. The location and extent of each eye's scotoma and PRL will be used as software inputs on either device. Perimetry using one or all of the methods above will be performed until acceptable information about the scotoma extent and location is obtained.

In a second visit, participants will perform the visual tasks that are used as the basis of their personalized remapping, letter perimetry. Participants will first view and report three randomly selected horizontally arranged letters placed at different locations in the visual field. This letter perimetry task will take about 40 min and will cover a large part of the visual field.

Participants will then read single words whose letters have been displaced from horizontal in various ways that comprise candidate remappings generated on the basis of the letter perimetry results. This personalization test will take about 40 minutes, and will find a good remapping strategy for the individual. Subjects will then be introduced to the reading tasks that comprise the remainder of the study

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 16 years or older
  • Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
  • Stable fixation (+/- 1 deg) using their PRL.
  • No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
  • Satisfactory calibration achievable using eye tracker

排除标准

  • Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
  • Poor fixation (worse than+/- 1 deg) using their PRL.
  • Cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
  • Satisfactory calibration not achievable using eye tracker

研究组 & 干预措施

Normally sighted with artificial scotoma

Active Comparator

No remapping (control condition), traditional remapping, personalized remapping

干预措施: Traditional Remapping (Behavioral)

Normally sighted with artificial scotoma

Active Comparator

No remapping (control condition), traditional remapping, personalized remapping

干预措施: Personalized Remapping (Behavioral)

Patients with scotoma

Experimental

No remapping (control condition), traditional remapping, personalized remapping

干预措施: Traditional Remapping (Behavioral)

Patients with scotoma

Experimental

No remapping (control condition), traditional remapping, personalized remapping

干预措施: Personalized Remapping (Behavioral)

结局指标

主要结局

Reading Speed for Natural Text Samples

时间窗: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day

How quickly participants can correctly read displayed text

Reading error rate for Individual Words

时间窗: Measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day

How many mistakes participants make

Reading Speed for Individual Words

时间窗: Measured during third visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day

How quickly participants can correctly read displayed text

Reading Speed for Sentences

时间窗: Measured during fourth visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day

How quickly participants can correctly read displayed text

Reading error rate for Sentences

时间窗: Measured during fourth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day

How many mistakes participants make

Reading error rate for Natural Text Samples

时间窗: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day

How many mistakes participants make

次要结局

  • Eye movement quality for sentences(Measured during fourth visit)
  • Eye fixation quality for natural text samples(Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day)
  • Eye fixation quality for words(Measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day)
  • Eye fixation quality for sentences(Measured during fourth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day)
  • Eye movement quality for natural text samples(Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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