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临床试验/NCT07216924
NCT07216924尚未招募不适用

Remapping Text in Sentence and Word Tasks to Aid Reading With Central Vision Loss

University of Minnesota2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2027年6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
尚未招募
入组人数
100
试验地点
2
主要终点
Sentence reading speed

研究概览

简要总结

Reading performance in patients with Central Vision Loss will be measured with and without missing text being remapped to different parts of the visual field in a variety of different reading tasks.

详细描述

Following initial characterization of their visual field loss, the participant's performance in various reading tasks will be measured with and without remapping. Tasks will include reading simple sentences, reading popular fiction, reading text with one word presented at a time (rapid serial visual presentation, RSVP), and reading text in simulated real-world environments in virtual reality (e.g. subway station, school, city street). Different remapping strategies, e.g. mainly shifting the text horizontally, or vertically, will be tested.

Participants interested in the study will be brought in for an initial visit where they will first be consented. 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 Ophthalmology department to give size and shape information. Participants will perform 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 The study then branches into three arms. In one arm, participants will be given repeated practice reading sentences with remappings. In XX additional sessions, participants will perform a single sentence reading tasks for remapped and non-remapped text: One sentence at a time will be displayed on the screen, and the task is simply to read aloud what was presented. Following blocks of this task with and without remapping, participants will be given extended practice reading with remapping. Participants read multiple sentences from a longer text (popular fiction) in multiple 10 minute blocks. Each sentence will be presented individually, and participants will continuously read one sentence after another taken from the fiction text.

In a second arm, participants will read sentences with one word at a time presented in rapid succession. This form of reading is called rapid serial visual presentation or RSVP. In an initial block of sentences, different word rates will be tested to determine the fastest rate where participants are accurate, with and without remapping. Then individual sentences and longer passages will be read as in the other arm, but with this different presentation method. Different remappings and no remapping will again be tested.

In a third arm, participants will read single words presented in naturalistic scenes viewed in a virtual reality environment and presented on a head mounted display. Words will be read with and without remapping. Several different environments will be tested (e.g. subway station, school, city street). The words will be natural text that could be found in these environments, e.g. subway station names, messages on a chalkboard, storefront shop names, etc.

In all sessions in all arms, the eye tracker will be calibrated to participants' individual head and eye position. This will involve fixating at different points on the device screen (HMD or desk-mounted) as the eye is imaged by the eye trackers. Throughout all testing, patients will be asked if they feel any discomfort, and will be able to take a break or quit testing at any point. Reading responses will be verbal and will scored for accuracy by a research assistant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • Dense bilateral scotomas of at least 2 deg diameter in each eye covering the fovea
  • Bivariate contour ellipse area (BCEA) of less than 10^2 is obtained in a simple fixation task

排除标准

  • Neovascular AMD
  • Any history of visual disorders other than that causing the central vision loss.

研究组 & 干预措施

Rapid Serial Visual Presentation

Experimental

Participants will read words presented one at a time in rapid succession near fixation.

干预措施: RSVP personalized remappi (Behavioral)

Reading in The Wild

Experimental

Participants will view scenes in virtual reality showing natural settings and read a single word at a time within those scenes- e.g. a name on a street sign or shop in a city scene.

干预措施: Reading text in the wild with remapping (Behavioral)

Perceptual Learning

Experimental

Participants will practice reading with remapping over many sessions on different days.

干预措施: Personalised Remapping Training (Behavioral)

结局指标

主要结局

Sentence reading speed

时间窗: Measured on day 35, end of the Personalised Remapping Training in the 33 participants in the Perceptual Learning arm.

Time it took to read sentence in words per minute

Sentence reading accuracy

时间窗: Measured on day 35, end of the Personalised Remapping Training in the 33 participants in the Perceptual Learning arm.

Percentage of correctly read words in sentence

Word reading speed: RSVP

时间窗: Measured on day 21, end of the RSVP Remapping intervention in the 33 participants in the Rapid Serial Visual Presentation arm.

Time taken to read each word

Word recognition accuracy: RSVP

时间窗: Measured on day 21, end of the RSVP Remapping intervention in the 33 participants in the Rapid Serial Visual Presentation arm.

Percentage of words correctly read

Word reading speed: Reading in The Wild

时间窗: Measured on day 21, end of the Reading Text in The Wild with Remapping intervention in the 33 participants in the Reading in The Wild arm.

Time taken to read each word

Word recognition accuracy: Reading in the wild

时间窗: Measured on day 21, end of the Reading Text in The Wild with Remapping intervention in the 33 participants in the Reading in The Wild arm.

Percentage of words correctly read

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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