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

7 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Liza Sharmini Binti Tajudin Prof
  • Numéro de téléphone: +6019-9179227
  • E-mail: liza@usm.my

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Standard Care Group
Group B patient will not be practicing reading rehabilitation module and will receive standard eye care.
Expérimental: Reading Module Group
Group A is the interventional group. Group A patients will be practicing reading rehabilitation module.
Autre: Reading Rehabilitation Module
Interventional group will be practicing reading rehabilitation module
Autres noms:
  • Groupe A

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Reading speed
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universiti Sains Malaysia

Les enquêteurs

  • Chaise d'étude: Mr. Mohd Bazlan Hafidz Mukrim Mohd Bazlan, Human Research Ethics Committee USM Division of Research & Innovation

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

28 février 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

28 juillet 2026

Première soumission répondant aux critères de contrôle qualité

28 juillet 2026

Première publication (Réel)

3 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • USM/JEPeM/KK/26060515

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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