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临床试验/NCT05600140
NCT05600140招募中不适用

Viewing Strategy Training in Children With (Cerebral) Visual Impairment: From Spontaneous Eye Movements to a Structured Viewing Strategy

Royal Dutch Visio1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月25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
发起方
入组人数
60
试验地点
1
主要终点
Changes in visual search accuracy after training

研究概览

简要总结

Viewing strategies are strategies used to process visual Information. Many children with visual impairment seem to lack systematic viewing strategies. However, it is unknown how viewing strategies differ between children with normal vision and children with (cerebral) visual impairment. In addition, viewing strategy training is often adopted in clinical practice, but till date there is no scientific evidence about effectiveness of this approach.

The current project has two goals: (1) to measure viewing strategies used by children with normal vision, children with ocular visual impairment and children with CVI, and (2) to evaluate whether training viewing strategies results in more efficiënt visual Information processing.

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
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • typically developing children with normal vision:
  • Age 5-12 years
  • linear distant visual acuity of 0.1 logMAR or better
  • Verbal IQ above 70
  • Absence of developmental disorders or psychiatric problems like ASS or AD(H)D
  • Inclusion criteria for children with ocular visual impairment:
  • Age 5-12 years
  • Children with linear distance visual acuity better <=1.3logMAR and >0.1 logMAR
  • Intact central visual field (at least > 30 degrees)
  • Children with a verbal IQ above 70
  • Absence of developmental disorders or psychiatric problems like ASS or AD(H)D
  • Inclusion criteria for children with cerebral visual impairment:
  • Age 5-12 years
  • Linear distance visual acuity <=0.3 logMAR
  • Having the diagnosis CVI (verified by ophthalmologists)
  • Children with a verbal IQ above 70
  • Absence of psychiatric problems like ASS or AD(H)D
  • Additional inclusion criterion for study 2 (evaluating training effectiveness): children with (cerebral) visual impairment should have an indication for viewing strategy training. Training should not be indicated if children have no problems performing academic tasks (i.e. when speed and accuracy of visual processing is within the normal range). The age range for study 2 is 5-9 years.

排除标准

  • Children with VI: linear near visual acuity >1.0 logMAR
  • Children with visual field defect < 30 degrees
  • Children with a verbal IQ below 70
  • Children who attended a form of vision training in the past two years
  • Children with psychiatric problems like ASS or AD(H)D
  • Auditory impairment or language impairments
  • Major life events during training

研究组 & 干预措施

Group A) early training group

Experimental

T0 = baseline measurement T1 = posttest (within two weeks after training) T2 = follow up measurement (6 months after training)

干预措施: Viewing strategy training (Behavioral)

Group B) late training group

Experimental

T0 = baseline measurement T1 = test-retest reliability and natural development (over period 1 1/2-2 months after T0) T2 = posttest (within two weeks after training)

干预措施: Viewing strategy training (Behavioral)

结局指标

主要结局

Changes in visual search accuracy after training

时间窗: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4

Accuracy during conjunction search

Changes in reading accuracy after viewing strategy training

时间窗: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4

Radner reading test

Changes in reading speed after viewing strategy training

时间窗: Group A: Day 0, Month 2, Month 8; group B: Day 0, Month 2, Month 4

Radner reading test

Changes in visual search speed after training

时间窗: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4

Speed during conjunction search

Changes in saccade amplitudes during reading and visual search after training

时间窗: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4

Saccade amplitudes measured using Radner reading test and conjunction search

Changes in fixation duration during reading and search after training

时间窗: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4

Fixation durations measured using Radner reading test and conjunction search

Changes in average distance between fixation points during conjunction search (EB-VSA) after training

时间窗: Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4

Average distance between fixation points using Radner reading test and conjunction search

次要结局

  • Changes in local visual selective attention after training(Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4)
  • Changes in global visual selective attention after training(Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4)
  • Changes in visual identification speed after training(Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4)
  • Changes in WISC-V visual processing speed index (VSI) after training(Group A: Day 0, Month 2, Month 8; Group B: Day 0, Month 2, Month 4)

研究者

发起方
Royal Dutch Visio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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