Evaluation of The Effectiveness Of Reading Rehabilitation Module On Reading Performance And Quality of Life In Patients With Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reading speed
研究概览
简要总结
The goal of this interventional study is to test the effectiveness of reading rehabilitation module towards reading speed and error, and quality of life in glaucoma patients.The main questions it aims to answer are:
- Is there a significant difference in reading speed over a 6-month period between glaucoma patients who undergo a reading rehabilitation module and those who receive standard care?
- To what extent does the implementation of a reading rehabilitation module reduce the frequency of reading errors in glaucoma patients compared to a control group across baseline, 3-month, and 6-month follow-ups?
- How does a structured reading rehabilitation module influence the self-reported quality of life in glaucoma patients from baseline to 6 months when compared to those receiving standard care?
Participants will:
Patients in interventional group will be instructed to practice the reading module for 20-30 minutes daily, minimum 3 days/week, for 6 months.
Visit the clinic once every 3 months for checkups and tests A logbook will be provided to record their practice sessions.
While participants in control group will receive standard care, visit the clinic once every 3 months for checkups and tests.
详细描述
Glaucoma is a leading cause of irreversible visual field loss, significantly impairing reading efficiency and vision-related quality of life. While conventional management focuses on intraocular pressure reduction to prevent disease progression, visual rehabilitation strategies targeting functional reading deficits remain limited in clinical practice. This randomized, single-blind, parallel-group control trial aims to evaluate the effectiveness of a structured, home-based reading rehabilitation module on reading performance and vision-related quality of life in patients with bilateral glaucoma.
Following ethical approval from the Human Research Ethics Committee of Universiti Sains Malaysia (JPeM), eligible patients attending the Ophthalmology Clinic at Hospital Universiti Sains Malaysia (HUSM) will be recruited and randomized into two arms: an intervention group receiving the reading rehabilitation module or a control group maintaining standard daily care (waitlist control). Randomization will be executed using sequentially numbered, opaque, sealed envelopes (SNOSE) to maintain allocation concealment.
Participants assigned to the intervention arm will receive standardized Malay-language narrative reading materials and will be instructed to practice the structured reading module at home for 20 to 30 minutes every 2-3days per week over a 6-month study period. Protocol adherence will be monitored using daily reading logs tracking session dates and durations, which will be audited during monthly follow-up visits. Participants maintaining less than 80% compliance will receive targeted counseling. Control group participants will receive standard clinical care and general visual health advice, with access to the rehabilitation materials offered upon completion of the 6-month trial.
Study assessments will be conducted at baseline, 3 months, and 6 months post-enrollment by an independent investigator blinded to group allocation. Reading performance metrics (reading speed in words per minute and error rate percentage) will be evaluated using the standardized Buari-Chen Malay Reading Chart at a 40 cm reading distance. Vision-related quality of life will be measured at baseline and 6 months using the validated, glaucoma-specific GLAUQOL-36 questionnaire (scored from 0 to 100, where higher scores reflect better quality of life). Data will be analyzed using repeated-measures ANOVA (RM-ANOVA) to evaluate time, group, and interaction effects across study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18- 80 years old.
- •Confirmed diagnosis of bilateral Primary Open Angle Glaucoma (POAG),Primary Angle Closure Glaucoma (PACG), Normotensive Glaucoma (NTG) and Juvenile Open Angle Glaucoma (JOAG).
- •Bilateral visual acuity of 6/60 and better.
- •Bilateral visual field defect more than 10degree from fixation.
- •Phakic without visually significant cataract.
- •Pseudophakic for more than 3 months prior to recruitment.
- •Literate patients.
排除标准
- •Ocular diseases other than glaucoma (e.g., age-related macula degeneration, diabetic retinopathy, moderate to severe cataract).
- •Other comorbidities that affect memory (e.g., stroke, cognitive disorders).
- •Cognitive disorders (e.g., diagnosed dementia or cognitive impairment).
- •Poorly controlled diabetes mellitus, hypertension and hyperlipidaemia.
- •Other media opacities.
- •History of previous intraocular surgery other than uncomplicated cataract within past 6 months.
研究组 & 干预措施
Standard Care Group
Group B patient will not be practicing reading rehabilitation module and will receive standard eye care.
Reading Module Group
Group A is the interventional group. Group A patients will be practicing reading rehabilitation module.
干预措施: Reading Rehabilitation Module (Other)
结局指标
主要结局
Reading speed
时间窗: Baseline, 3rd month and 6th month
Reading speed will be assessed using the Buari-Chen Malay Reading Chart. Reading speed will be calculated in words per minute (wpm) using the following formula: "Reading Speed (wpm)"=("Total words read correctly" /"Total time in seconds" )×60
Reading error
时间窗: At baseline, 3rd month and 6th month
Reading error will also be assessed using the Buari-Chen Malay Reading Chart. an error rate will be calculated as a percentage, using the formula: "Error Rate (%)"=("Number of Errors" /"Total Words" )×100
GlauQol-36 Questionnaire
时间窗: At baseline and 6th month
Vision-related quality of life will be evaluated using the Glaucoma Quality of Life 36-item Questionnaire (GLAUQOL-36). The questionnaire covers 10 visual domains on a Likert scale. Individual item responses are aggregated and converted to a total standardized score ranging from 0 to 100, where higher scores indicate a better vision-related quality of life.
Change in Reading speed
时间窗: Baseline, 3rd month and 6th month
Reading speed will be assessed using the Buari-Chen Malay Reading Chart at a 40 cm reading distance. Participants read a standardized paragraph aloud. Reading speed is calculated as: Reading Speed (wpm)= (Total words read correctly} / Total time in seconds) x 60.
Change in Reading error
时间窗: At baseline, 3rd month and 6th month
Reading errors (omissions, substitutions, mispronunciations, or skipped words) will be recorded using the Buari-Chen Malay Reading Chart. The error rate is calculated as: Error Rate (%) = (Number of Errors / Total Words) x 100.
次要结局
未报告次要终点
研究者
Dr. Nur Izzati Binti Mohd Salim
Principal Investigator
Universiti Sains Malaysia