Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema (DMO)- Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in visual processing speed
研究概览
简要总结
Diabetic macular oedema (DMO) is a sight-threatening problem for diabetic patient who has swelling in macula. Patients with DMO can receive laser treatment and achieve good acuity finally. However, some patients still have difficulties in reading even after proper treatment.
In this project, the investigators aimed to explore the effectiveness of different training paradigms in improving reading performance in patients with DMO.
详细描述
Patients with diabetic macular oedema (DMO), after receiving laser photocoagulation, achieved good outcomes in distance acuity. However, some patients, particularly those developing parafoveal scotoma, still had difficulty in reading. Inability to read or reading very slowly leads to the potential loss of job, as well as the enjoyment of reading for leisure.
In this study, the investigators aimed to investigate the effectiveness of reading rehabilitation using perceptual learning paradigms in enhancing reading performance in patients with reading difficulties due to DMO. Also, the fundamental mechanisms explaining the reading problems in patients with DMO reading Chinese will be examined.
The investigators hypothesize that the perceptual training would show an improvement in reading. The investigators' primary hypothesis is that temporal visual processing speed and spatial visual span will be improved after perceptual training. The investigators' secondary hypothesis is that the reading speed and fixation stability will be improved after training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read Chinese.
- •No formal vision rehabilitation training in reading after vision loss
- •Diagnosis of diabetic macular oedema (DMO) and had previous treatment with laser and / or intravitreal injections
- •Reasonable control of blood glucose level (HbA1c <10) to minimize the impact of vision fluctuation
- •Education level of 6 years or more (primary school or above)
排除标准
- •Receive any types of eye treatments other than those mentioned above
- •Any diagnosed ocular diseases other than DMO
- •Severe medical problems or self reported neurological or cognitive disorders
- •Serious hearing impairment
- •Previously attended vision rehabilitation clinic
研究组 & 干预措施
Temporal Group
Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
干预措施: Temporal Group (Other)
Spatial Group
Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
干预措施: Spatial Group (Other)
Combined Group
Receive 6 weekly 1-hour training sessions by Trigrams (A tailor made reading-task training programme).
干预措施: Combined Group (Other)
Control Group
Receive 6 weekly 1-hour training sessions of leisure reading activities
干预措施: Control Group (Other)
结局指标
主要结局
Change in visual processing speed
时间窗: Change from baseline at week 6 and change from baseline at week 12 week
Using trigrams to measure the character-recognition accuracy while characters are presented at different exposure times
Change in visual span size
时间窗: Change from baseline at week 6 and change from baseline at week 12 week
Using trigrams to measure the character-recognition accuracy while characters are presented at different positions
次要结局
- Change in reading performance(Change from baseline at week 6 and change from baseline at week 12 week)
- Change in fixation stability(Change from baseline at week 6 and change from baseline at week 12 week)
- Change in Chinese version of Impact of Visually Impaired (C-IVI) measure(Change from baseline at week 6 and change from baseline at week 12 week)
研究者
Allen MY Cheong
Assistant Professor
The Hong Kong Polytechnic University