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临床试验/NCT05603962
NCT05603962已完成不适用

The Effectiveness of Visual Training Using Prisms on Visual Symptoms and Binocular Vision in Convergence Insufficiency Patients

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年3月6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
12
试验地点
1
主要终点
Binocular vision and visual function evaluation

研究概览

简要总结

Convergence insufficiency (CI) is one of the most common binocular vision disorders. The prevalence of CI ranges from 3% to 6% in school-aged children. CI symptoms include visual fatigue, headache, blurred vision, and diplopia and could be caused while using near-distance viewing. These symptoms might become more severe with increasing need to perform near-distance tasks. Long-term visual symptoms could result in a negative impact on learning behaviors and work performance in patients. Nowadays, visual training is the main type of management for CI patients clinically; however, the existing training protocol required patients to make several visits to the clinic for visual training, which might increase the burden for patients and result in higher failures in training. Therefore, this study will use a simple training method by utilizing prisms for CI patients to train at home, then compare visual symptoms and binocular vision after the training. In stage I of this study, investigators will recruit 60 symptomatic CI participants aged 9 to 30 years old to do a 6-week visual training with the prisms (15 min/time, 3 times/week). The post-training outcomes will be collected at week 4 and week 6. In stage II, all of the participants will be randomly divided into the "stop training group" and the "continue training group." The participants in the "continue training group" will have the same 6-week prism training and in the "stop training group" will stop all the prism training during this period. The final post-training outcomes of all the participants will be collected again at week 12. In this study, investigators will investigate the effectiveness of the prisms training for 6 weeks and for 12 weeks on visual symptoms and binocular vision in CI patients, and evaluate whether the training effect will be affected by stopping training after 6 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
9 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The overall score of CI symptom survey ≥ 16 (9-18 years old) or ≥ 21 (19-30 years old)
  • •The break point of near point of convergence (NPC) ≥ 6 cm
  • •Exophoria at near distances be at least 4∆ higher than at far distances
  • •Near positive fusional vergence (PFV) ≤ 15∆ or failing Sheard's criterion at near.

排除标准

  • •The best corrected visual acuity (BCVA) of < 20/25 in each eye at far and near distances
  • •Amblyopia patients or the difference of BCVA between the two eyes ≥ 2 lines
  • •Constant strabismus patients
  • •History of strabismus surgery or refractive surgery
  • •Systemic diseases that would affect binocular vision
  • •Acquired brain injury or neurological disorder.

研究组 & 干预措施

Stop training group

Active Comparator

Home-base prism training during week 1-6 --> then stop training during week 7-12 --> endpoint data collected at week 12

干预措施: Visual training (Behavioral)

Continune training group

Experimental

Home-base prism training during week 1-12 --> endpoint data collected at week 12

干预措施: Visual training (Behavioral)

结局指标

主要结局

Binocular vision and visual function evaluation

时间窗: 12 weeks for each participant

Change from baseline best corrected visual acuity: distance visual acuity measured for each eye at a distance of 6 m and at near 40 cm for each eye will be measured using Snellen charts. NPC and the amplitude of accommodation will be measured using Royal Air Force (RAF) rule. Stereoacuity will be measured by the Random dot stereotest.

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 (1)

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