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

NCT07741812 | Not Yet Recruiting

• 1 other identifier: USM/JEPeM/KK/26060515
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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?

Conditions

Primary Angle Closure Glaucoma; Normotensive Glaucoma; Juvenile Open Angle Glaucoma; Primary Open Angle Glaucoma (POAG)

Keywords

Vision, Low; Reading Rehabilitation; Visual Acuity; Randomized Controlled Trial; Patient Compliance; Structured Reading Module; Self Care; Malay Language.

Outcome Measures

Primary Outcomes (3)

• Reading speed

  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

  Baseline, 3rd month and 6th month

• Reading error

  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

  At baseline, 3rd month and 6th month

• GlauQol-36 Questionnaire

  Vision-related quality of life will be assessed using the GLAUQOL-36 Questionnaire

  At baseline and 6th month

Study Arms (2)

Group B

NO INTERVENTION

Group B patient will not be practicing reading rehabilitation module and will receive standard eye care.

Group A

EXPERIMENTAL

Group A is the interventional group. Group A patients will be practicing reading rehabilitation module.

Other: Reading Rehabilitation Module

Interventions

Reading Rehabilitation Module OTHER

Interventional group will be practicing reading rehabilitation module

Also known as: Group A

Group A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (12)

• McKean-Cowdin R, Wang Y, Wu J, Azen SP, Varma R; Los Angeles Latino Eye Study Group. Impact of visual field loss on health-related quality of life in glaucoma: the Los Angeles Latino Eye Study. Ophthalmology. 2008 Jun;115(6):941-948.e1. doi: 10.1016/j.ophtha.2007.08.037. Epub 2007 Nov 12.

  PMID: 17997485 BACKGROUND

• Lisboa R, Chun YS, Zangwill LM, Weinreb RN, Rosen PN, Liebmann JM, Girkin CA, Medeiros FA. Association between rates of binocular visual field loss and vision-related quality of life in patients with glaucoma. JAMA Ophthalmol. 2013 Apr;131(4):486-94. doi: 10.1001/jamaophthalmol.2013.2602.

  PMID: 23450425 BACKGROUND

• Gobeille M, Malkin A, Jamara R, Ross NC. Clinical outcomes of low vision rehabilitation delivered by a mobile clinic. Ophthalmic Physiol Opt. 2018 Mar;38(2):193-202. doi: 10.1111/opo.12440.

  PMID: 29485207 BACKGROUND

• Lamoureux EL, Pallant JF, Pesudovs K, Rees G, Hassell JB, Keeffe JE. The effectiveness of low-vision rehabilitation on participation in daily living and quality of life. Invest Ophthalmol Vis Sci. 2007 Apr;48(4):1476-82. doi: 10.1167/iovs.06-0610.

  PMID: 17389474 BACKGROUND

• Freeman EE, Munoz B, West SK, Jampel HD, Friedman DS. Glaucoma and quality of life: the Salisbury Eye Evaluation. Ophthalmology. 2008 Feb;115(2):233-8. doi: 10.1016/j.ophtha.2007.04.050. Epub 2007 Jul 26.

  PMID: 17655930 BACKGROUND

• Flaxman SR, Bourne RRA, Resnikoff S, Ackland P, Braithwaite T, Cicinelli MV, Das A, Jonas JB, Keeffe J, Kempen JH, Leasher J, Limburg H, Naidoo K, Pesudovs K, Silvester A, Stevens GA, Tahhan N, Wong TY, Taylor HR; Vision Loss Expert Group of the Global Burden of Disease Study. Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis. Lancet Glob Health. 2017 Dec;5(12):e1221-e1234. doi: 10.1016/S2214-109X(17)30393-5. Epub 2017 Oct 11.

  PMID: 29032195 BACKGROUND

• Elliott DB, Patel B, Whitaker D. Development of a reading speed test for potential-vision measurements. Invest Ophthalmol Vis Sci. 2001 Jul;42(8):1945-9.

  PMID: 11431465 BACKGROUND

• Friedman DS, Freeman E, Munoz B, Jampel HD, West SK. Glaucoma and mobility performance: the Salisbury Eye Evaluation Project. Ophthalmology. 2007 Dec;114(12):2232-7. doi: 10.1016/j.ophtha.2007.02.001. Epub 2007 Nov 5.

  PMID: 17980433 BACKGROUND

• Christensen K, Doblhammer G, Rau R, Vaupel JW. Ageing populations: the challenges ahead. Lancet. 2009 Oct 3;374(9696):1196-208. doi: 10.1016/S0140-6736(09)61460-4.

  PMID: 19801098 BACKGROUND

• Chan EW, Li X, Tham YC, Liao J, Wong TY, Aung T, Cheng CY. Glaucoma in Asia: regional prevalence variations and future projections. Br J Ophthalmol. 2016 Jan;100(1):78-85. doi: 10.1136/bjophthalmol-2014-306102. Epub 2015 Jun 25.

  PMID: 26112871 BACKGROUND

• Burton R, Crabb DP, Smith ND, Glen FC, Garway-Heath DF. Glaucoma and reading: exploring the effects of contrast lowering of text. Optom Vis Sci. 2012 Sep;89(9):1282-7. doi: 10.1097/OPX.0b013e3182686165.

  PMID: 22885786 BACKGROUND

• Abe RY, Diniz-Filho A, Zangwill LM, Gracitelli CP, Marvasti AH, Weinreb RN, Baig S, Medeiros FA. The Relative Odds of Progressing by Structural and Functional Tests in Glaucoma. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT421-8. doi: 10.1167/iovs.15-18940.

  PMID: 27409501 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Patient Compliance

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mr. Mohd Bazlan Hafidz Mukrim Mohd Bazlan

  Human Research Ethics Committee USM Division of Research & Innovation

  STUDY CHAIR

Central Study Contacts

Nur Izzati Binti Mohd Salim Dr

CONTACT

+6013-4741841; drizzatisalim@student.usm.my

Liza Sharmini Binti Tajudin Prof

CONTACT

+6019-9179227; liza@usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

MY (1)