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临床试验/NCT05637385
NCT05637385尚未招募不适用

Training Oculo-motor Control to Improve Vision When Using a Preferred Retinal Locus

Russell L. Woods0 个研究点目标入组 24 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
主要终点
reading speed following eight training sessions

研究概览

简要总结

When high-detail vision is lost due to a retinal disease such as macular degeneration, people see poorly, and have difficulty with eye movements (oculo-motor control). This preliminary study will investigate a potential behavioral intervention that may improve the ability to perform vision-related daily activities such as reading, recognising faces and watching television. The intervention involves many sessions that will train visual perception and eye movements over a period of a few months. Participants will have either lost central vision in both eyes or have normal vision (control group).

详细描述

The purpose of the study is evaluate a potential treatment for loss of (foveal) central vision in both eyes which results in the use of a preferred retinal locus (PRL). The treatment is a series of 16 sessions of about one-hour duration that will involve a mixture of oculomotor control (OMC) training, perceptual training, and scotoma awareness. Two groups will receive the training: (1) central vision loss; and (2) normal sight who will use a simulated scotoma (called control group below).

A single-site, two-way mixed factor, one within-subject and one between-subject, minimal-risk phase-2 study. Each participant with vision loss or in the control group will attend for three outcome-measurement visits and 16 training visits over a period of about two months (at 2 visits per week). Feasibility metrics will be obtained during recruitment and study conduct. PRL and OMC metrics will be obtained at every visit. Outcome metrics will be obtained before treatment, following 8 training sessions, and following 16 training sessions.

Participants in the control group will experience a simulated central scotoma created by a gaze-contingent visual display system that simulates the loss of central vision by obscuring a region of central vision during testing and training.

Participants will be trained using an integrated oculo-motor and perceptual training approach using a gaze-contingent visual display to provide scotoma awareness. Two tasks will alternate: (1) a textured search target that suddenly shifts, drifts smoothly, or is stable, requiring the subject to make a saccade, a smooth pursuit, or fixate, respectively, following which there is a same-different task to test attention; and (2) target following and visual search for (a) face within distractors, (b) object recognition and location, and (c) word recognition and object identification over cluttered background. During training, for the vision-loss group, the binocular scotoma (created by the retinal lesions) will be outlined using a gaze-contingent system, so that the subject will see a border at the edge of their binocular scotoma that moves with gaze, alerting them to the location of the scotoma.

In addition to the 16 training sessions, there will be longer (2.5 to 3 hours) measurement sessions: (1) before training; (2) after 8 training sessions; and (3) after 16 training sessions. Due to the number of procedures, the first measurement session might consist of two sessions. Thus, each participant with vision loss will participate in 19 or 20 sessions in total.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Central Vision Loss Group
  • Inclusion Criteria:
  • Bilateral foveal loss that includes the fovea in each eye, as determined through retinal examination
  • fluent in English
  • Cognitive function MoCA (Montreal Cognitive Assessment) test >20
  • Binocular visual acuity 20/800 or better
  • able to sit for at least an hour

排除标准

  • speech impediment
  • history of neurological or psychiatric disease
  • inability to provide informed consent
  • inability to follow instructions in English
  • Normal Vision Control Group
  • Inclusion Criteria:
  • fluent in English
  • Cognitive function MoCA (Montreal Cognitive Assessment) test >25
  • Binocular visual acuity 20/40 or better
  • able to sit for at least an hour
  • Exclusion Criteria:
  • any ophthalmic disease that might impact on the conduct of the study, especially conditions that cause vision field loss
  • speech impediment
  • history of neurological or psychiatric disease
  • inability to provide informed consent
  • inability to follow instructions in English

结局指标

主要结局

reading speed following eight training sessions

时间窗: comparing reading speed before intervention and after 8 sessions of training

reading of paragraphs of text

reading speed following sixteen training sessions

时间窗: comparing reading speed before intervention and after 16 sessions of training

reading of paragraphs of text

face discrimination threshold following eight training sessions

时间窗: comparing face discrimination thresholds before intervention and after 8 sessions of training

recognizing differences between faces

face discrimination threshold following sixteen training sessions

时间窗: comparing face discrimination thresholds before intervention and after 16 sessions of training

recognizing differences between faces

video comprehension (shared word score) following eight training sessions

时间窗: comparing shared word scores before intervention and after 8 sessions of training

understanding and describing the content of short video clips

video comprehension (shared word score) following sixteen training sessions

时间窗: comparing shared word scores before intervention and after 16 sessions of training

understanding and describing the content of short video clips

次要结局

  • PRL location relative to the location before the intervention (training)(location at each of the 16 training sessions as compared to the location before intervention)
  • Oculo-motor reference location relative to the location before the intervention (training)(at each of the 16 training sessions as compared to the location before intervention)
  • saccade dynamics relative to the location before the intervention (training)(at each of the 16 training sessions as compared to the location before intervention)
  • single-letter visual acuity following eight training sessions(comparing visual acuity before intervention and after 8 sessions of training)
  • single-letter visual acuity following sixteen training sessions(comparing visual acuity before intervention and after 16 sessions of training)
  • letter contrast sensitivity following eight training sessions(comparing letter contrast sensitivity before intervention and after 8 sessions of training)
  • letter contrast sensitivity following sixteen training sessions(comparing letter contrast sensitivity before intervention and after 16 sessions of training)
  • Geriatric Depression Scale (GDS) following eight training sessions(comparing GDS scores before intervention and after 8 sessions of training)
  • Geriatric Depression Scale (GDS) following sixteen training sessions(comparing GDS scores before intervention and after 16 sessions of training)
  • Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following eight training sessions(comparing VA LV VFQ scores before intervention and after 8 sessions of training)
  • Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ) following sixteen training sessions(comparing VA LV VFQ scores before intervention and after 16 sessions of training)

研究者

发起方
Russell L. Woods
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Russell L. Woods

Associate Scientist

Schepens Eye Research Institute

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