An interventional study of Reading Rehabilitation Module in Primary Open Angle Glaucoma (POAG), Juvenile Open Angle Glaucoma and Normotensive Glaucoma, sponsored by Universiti Sains Malaysia. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Other
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:
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.
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.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Group B patient will not be practicing reading rehabilitation module and will receive standard eye care.
Group A is the interventional group. Group A patients will be practicing reading rehabilitation module.
Other: Reading Rehabilitation Module
Interventional group will be practicing reading rehabilitation module
Also known as: Group A
Change in Reading speed
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.
Time frame: Baseline, 3rd month and 6th month
Change in Reading error
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.
Time frame: At baseline, 3rd month and 6th month
GlauQol-36 Questionnaire
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.
Time frame: At baseline and 6th month
Plan to share: Yes — De-identified individual participant data (including baseline demographics, visual acuity outcomes, reading performance metrics, and compliance logs) will be made available upon reasonable request. Data will be shared with qualified academic researchers following the publication of the primary thesis results, subject to approval by the principal investigator and institutional ethics committee. Data will be shared via secure email transmission.
Supporting information: Study protocol, Informed consent form
Time frame: Supporting documents and de-identified IPD will become available starting 6 months following the official publication of the thesis or primary journal manuscript, and will remain available for up to 5 years.
Access criteria: Access will be granted to qualified academic researchers, clinicians, and statistical meta-analysts affiliated with recognized research or academic institutions who present a scientifically sound proposal. Requesters will be able to access the de-identified individual participant dataset (IPD) containing baseline demographics, clinical reading metrics, and adherence logs, as well as supporting documents including the Study Protocol and blank Informed Consent Form (ICF). Interested researchers must submit a formal request and a brief research plan directly to the Principal Investigator via institutional email. Data will be transmitted securely (e.g., encrypted file transfer) once the proposal is reviewed and a standard Data Use Agreement (DUA) is signed by both parties.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 100 non-industry interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 57. This study's planned 5 months is below that.
Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.