Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients

Objective General: To evaluate the effectiveness of a reading rehabilitation module on reading performance and quality of life in patients with glaucoma.

Specific:

• To compare the reading speed at baseline, 3 month, and 6 month in patients with glaucoma who received reading rehabilitation module and those who do not receive them.
• To compare the reading error at baseline, 3 month, and 6 month in patients with glaucoma who received reading rehabilitation module and those who do not receive them.
• To compare the quality of life at baseline and 6 month in patients with glaucoma who received reading rehabilitation module and those who do not receive them.

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Methods of Data Collection

This study will be conducted after obtaining ethical approval from the Universiti Sains Malaysia Ethical Committee (JPeM) and will be conducted in accordance to World Medical Association Declaration of Helsinki ethical principles for medical research involving human subjects.

Recruitment of Subject

Patient diagnosed with Primary Open Angle Glaucoma (POAG),Primary Angle Closure Glaucoma (PACG), Normotensive Glaucoma (NTG) and Juvenile Open Angle Glaucoma (JOAG) attending Ophthalmology clinic, Hospital USM during study duration and fulfilled study inclusion and exclusion criteria. An informed and written consent will be taken and information form given to patients. The selected patients will be randomized into 2 groups (A and B) using sequentially numbered, opaque sealed envelopes (SNOSE). Group A patient will be practicing the reading module and group B patient will not be practicing them.

Study Design and Duration The intervention will be conducted over a continuous 6-month study period. Participants will be randomized into either the intervention group (structured reading rehabilitation) or the control group.

Intervention Arm (Structured Reading Module) Participants assigned to the intervention group will be prescribed a structured home-based reading rehabilitation program. They will be instructed to practice the reading module daily at home for a minimum of 20 to 30 minutes per day throughout the 6-month study duration.

Control Arm Participants allocated to the control group will not receive the structured reading module and will maintain their usual daily routine without participating in the home-based reading rehabilitation practice.

Logistics and Reading Materials At baseline, participants in the intervention arm will be provided with standardized reading materials. The materials consist of structured narrative stories compiled in the Malay language, designed to facilitate consistent daily practice.

Adherence and Compliance Monitoring To monitor protocol adherence and compliance, participants in the intervention group will be issued a standardized daily reading log at the start of the study. Participants will be required to record the date, daily duration (in minutes), and completion of each reading session. These reading logs will be collected and reviewed during scheduled follow-up visits to verify participant compliance and ensure overall protocol fidelity.

Reading speed

Reading speed will be assessed using the Buari-Chen Malay Reading Chart, a standardized tool designed for evaluating reading performance among low-vision and glaucoma patients in Malaysia. During the assessment, participants will be instructed to read aloud a standardized Malay paragraph at a comfortable reading distance, typically 40 cm. Timing begins at the first word and ends at the final word read. If the participant pauses for more than five seconds during reading, the test will be temporarily paused, and the total reading duration will be recorded accordingly.

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 speed will be taken at baseline, third and sixth month post recruitment for group A and B.

Reading Error

Reading error will also be assessed using the Buari-Chen Malay Reading Chart. Errors will be defined as any omissions, substitutions, mispronunciations, or skipped words during the reading task. Each passage will be evaluated, and the total number of errors will be recorded. Additionally, an error rate will be calculated as a percentage, using the formula:

"Error Rate (%)"=("Number of Errors" /"Total Words" )×100 Reading errors will be taken at baseline, third and sixth month post recruitment for group A and B.

GlauQol-36 Questionnaire

Vision-related quality of life will be assessed using the GLAUQOL-36 Questionnaire, a validated, glaucoma-specific tool that includes 36 questions across ten domains, such as daily activities, emotional well-being, visual discomfort, and social interaction. The questionnaire will be self-administered in a quiet setting, but for participants with limited literacy or significant visual impairment, guided administration will be provided by trained personnel. Each item is scored using the original Likert scale as provided in the validated version, and the overall score will be converted to a 0-100 scale. In this scale, a higher score indicates better vision-related quality of life. Assessments will be conducted at baseline and at 6 months after intervention.

Data Entry and Statistical Analysis

The data entry and analysis will be performed by using Statistical Package for the Social Sciences (SPSS) version 29 licensed to USM.

Paired T-test Chi-square test A one-way repeated measures analysis of variance (RM ANOVA)

To minimize procedural and measurement errors, several quality control measures will be implemented:

Assessor Blinding: All outcome measures (e.g., baseline and post-intervention evaluations) will be conducted by an independent investigator who is blinded to participant group allocation.

Adherence Verification: Reading logs will be audited during monthly follow-up visits. Participants who log less than 80% of required practice sessions will be flagged for targeted compliance counseling.

Contamination Control: Control participants will receive standard clinical care and general visual health advice, but will not receive structured rehabilitation materials until the completion of the 6-month study period (waitlist control design).

Inclusion criteria

• 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.

Exclusion criteria

• 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.