Testing a Reading Module to Improve Reading Skills and Quality of Life in Glaucoma Patients
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:
- 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?
- 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?
- 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Nur Izzati Binti Mohd Salim Dr
- 전화번호: +6013-4741841
- 이메일: drizzatisalim@student.usm.my
연구 연락처 백업
- 이름: Liza Sharmini Binti Tajudin Prof
- 전화번호: +6019-9179227
- 이메일: liza@usm.my
연구 장소
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Kelantan
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Kota Bharu, Kelantan, 말레이시아, 16150
- Universiti Sains Malaysia
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연락하다:
- Izzati Salim
- 이메일: drizzatisalim@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Standard Care Group
Group B patient will not be practicing reading rehabilitation module and will receive standard eye care.
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실험적: Reading Module Group
Group A is the interventional group.
Group A patients will be practicing reading rehabilitation module.
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Interventional group will be practicing reading rehabilitation module
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Reading speed
기간: Baseline, 3rd month and 6th month
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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.
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Baseline, 3rd month and 6th month
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Change in Reading error
기간: At baseline, 3rd month and 6th month
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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.
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At baseline, 3rd month and 6th month
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GlauQol-36 Questionnaire
기간: At baseline and 6th month
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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.
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At baseline and 6th month
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공동 작업자 및 조사자
수사관
- 연구 의자: Mr. Mohd Bazlan Hafidz Mukrim Mohd Bazlan, Human Research Ethics Committee USM Division of Research & Innovation
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- USM/JEPeM/KK/26060515
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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