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

7 augusti 2026 uppdaterad av: Dr. Nur Izzati Binti Mohd Salim, Universiti Sains Malaysia

Evaluation of The Effectiveness Of Reading Rehabilitation Module On Reading Performance And Quality of Life In Patients With Glaucoma

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:

  1. 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?
  2. 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?
  3. 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

  • Namn: Liza Sharmini Binti Tajudin Prof
  • Telefonnummer: +6019-9179227
  • E-post: liza@usm.my

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Standard Care Group
Group B patient will not be practicing reading rehabilitation module and will receive standard eye care.
Experimentell: Reading Module Group
Group A is the interventional group. Group A patients will be practicing reading rehabilitation module.
Övrig: Reading Rehabilitation Module
Interventional group will be practicing reading rehabilitation module
Andra namn:
  • Grupp A

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Reading speed
Tidsram: 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.
Baseline, 3rd month and 6th month
Change in Reading error
Tidsram: 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.
At baseline, 3rd month and 6th month
GlauQol-36 Questionnaire
Tidsram: 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.
At baseline and 6th month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Universiti Sains Malaysia

Utredare

  • Studiestol: Mr. Mohd Bazlan Hafidz Mukrim Mohd Bazlan, Human Research Ethics Committee USM Division of Research & Innovation

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

28 februari 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

28 juli 2026

Först inskickad som uppfyllde QC-kriterierna

28 juli 2026

Första postat (Faktisk)

3 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • USM/JEPeM/KK/26060515

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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