Malay Glaucoma Eye Study II Navigation, Mobility and Reading Ability in Primary Glaucoma

NCT04736264 | Unknown DMC

• 2 other identifiers: Universiti Sains MalaysiaRUI 1001/PPSP/8012350
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

With the improvement of health system, the life span of Asians has increased tremendously especially in Malaysia. As an early preparation to be an 'aging country' in 2023, Malaysia needs to prepare infrastructure and policy to improve quality of life (QoL) in older adults. Glaucoma is an aging related chronic disease that cause progressive optic neuropathy and visual field defect1. The main aim of glaucoma treatment is to slow down disease progression and preserve patient's QoL2. Modification of intraocular (IOP) is believed to be the mainstay of treatment but may not prevent progression of the disease. Modification of lifestyle has been found to change the prognosis of many chronic diseases such as diabetes mellitus. However, there is minimal evidence on the effect of lifestyle modification on glaucoma. Although constricted visual field almost asymptomatic especially in primary open angle glaucoma but many domestic injuries such as fall has been reported. Glaucoma patients reported greatest restriction with mobility especially driving compared to the other domains3,4. Reduction of walking and moderate-to-vigorous physical activity was also found in those with bilateral visual field loss5. Progressive constriction of visual field has been found to increase dependency, reduce mobility, pleasure of reading and QoL of glaucoma patients6. This will lead to psychological and emotional disturbance, in certain cases even resulted in depression. On the other hand, being physically active is found to have some protective effect against development and severity of glaucoma8,9. Thus, identifying problems related to physical activities in constricted visual field is important for improvement of rehabilitation and exercise regime for glaucoma patients. An exercise regime must be effective without causing major changes to IOP, safe in patients with constricted visual field and sensitive to social culture of Malaysians. Addressing these issues will lessen dependency and promotes healthy living among older adults. Improvement in navigation perhaps may increase the physical activities in glaucoma. Reading is another important pleasure in life. Visual field defect in glaucoma patients has been reported to associate with slower reading speed, saccade rate and visual span10,11. Identification of factors associated with difficulty in reading among glaucoma patients and development of rehabilitation regime in reading may improve the happiness index in literate patients. Nevertheless, there is no specific rehabilitation program to improve reading abilities among glaucoma patients. A combination of visual rehabilitation of low vision therapy and occupational therapy is ideal. Although, there is improvement in reading ability and mobility post low visual aid rehabilitation but there is no evidence on glaucoma patients specifically12. Improvement in daily living and dependency may improve their QoL. Happiness perhaps may improve the balance between oxidative stress damage and antioxidant level. Many previous studies discovered that various biomarkers of oxidative stress are elevated in people with depression, and anxiety disorders13. Similarly, oxidative stress has been implicated in pathogenesis of glaucoma and accelerates retinal ganglion cell damage in glaucoma14. Indirectly, improvement of QoL will help in halting the progression of visual field defect. Based on the previous research project on Malays in Malaysia, navigation and mobility has been identified to be mostly affect in primary glaucoma patients based on QoL questionnaires. Physical activities have potential protective effect against progression and severity of glaucoma9. Improvement in navigation, physical activities and reading ability, perhaps may improve their QoL. The main problem is how do we improve their navigation, physical activities and reading ability despite their constricted visual field. The most important step is to understand the problem and issues pertaining to the navigation, physical activities and reading faced by patients with glaucoma.

Conditions

Primary Open Angle Glaucoma; Primary Angle Closure Glaucoma

Keywords

Rehabilitation; Navigation; Mobility; Physical activity; Reading; Quality of life; Oxidative Stress; Exercise

Outcome Measures

Primary Outcomes (30)

• Navigation: completion of maze

  Time to complete the maze (minutes)

  Baseline (before randomization)

• Navigation: completion of maze

  Time to complete the maze (minutes)

  24 weeks after randomization

• Navigation: number of obstacles

  Number of stumbles and bumps while walking through the maze (number)

  Baseline (before randomization)

• Navigation: number of obstacles

  Number of stumbles and bumps while walking through the maze (number)

  24 weeks after randomization

• Mobility at home

  Accelerometer reading (steps/day)

  Baseline (before randomization)

• Mobility at home

  Accelerometer reading (steps/day)

  2 weeks after randomization

• Mobility at home

  Accelerometer reading (steps/day)

  4 weeks after randomization

• Mobility at home

  Accelerometer reading (steps/day)

  8 weeks after randomization

• Mobility at home

  Accelerometer reading (steps/day)

  16 weeks after randomization

• Mobility at home

  Accelerometer reading (steps/day)

  24 weeks after randomization

• Physical activity and exercise

  Accelerometer reading of moderate-vigorous physical activity (MVPA) (number)

  Baseline (before randomization)

• Physical activity and exercise

  Accelerometer reading of moderate-vigorous physical activity (MVPA) (number)

  2 weeks after randomization

• Physical activity and exercise

  Accelerometer reading of moderate-vigorous physical activity (MVPA) (number)

  4 weeks after randomization

• Physical activity and exercise

  Accelerometer reading of moderate-vigorous physical activity (MVPA) (number)

  8 weeks after randomization

• Physical activity and exercise

  Accelerometer reading of moderate-vigorous physical activity (MVPA) (number)

  16 weeks after randomization

• Physical activity and exercise

  Accelerometer reading of moderate-vigorous physical activity (MVPA) (number)

  24 weeks after randomization

• Reading speed of near vision chart

  Number of words per minute

  Baseline (before randomization

• Reading speed of near vision chart

  Number of words per minute

  24 weeks after randomization

• Reading speed of the provided materials (prescription label and newspaper)

  Number of words per minute

  Baseline (before randomization)

• Reading speed of the provided materials (prescription label and newspaper)

  Number of words per minute

  24 weeks after randomization

• Reading speed of the given book

  Number of pages per hour

  Baseline (before randomization)

• Reading speed of the given book

  Number of pages per hour

  8 weeks after randomization

• Reading speed of the given book

  Number of pages per hour

  16 weeks after randomization

• Reading speed of the given book

  Number of pages per hour

  24 weeks after randomization

• Quality of life score

  Total score from each domains of Bahasa Malaysia version of Glaucoma Quality of life 36 questionnaire (GlauQoL 36) using likert scoring 1-5

  Baseline (before randomization)

• Quality of life score

  Total score from each domains of Bahasa Malaysia version of Glaucoma Quality of life 36 questionnaire (GlauQoL 36) using likert scoring 1-5

  24 weeks after randomization

• Depression score

  Using Bahasa Malaysia version of geriatric depression scale 14 (MGDS 14) questionnaire. The score of 8 and above is considered as depressed.

  Baseline (before randomization)

• Depression score

  Using Bahasa Malaysia version of geriatric depression scale 14 (MGDS 14) questionnaire. The score of 8 and above is considered as depressed.

  24 weeks after randomization

• Serum total anti-oxidant capacity (TAC)

  The concentration of the TAC level (Ta) using a commercialized kit (QuantiChromTM Antioxidant Assay Kit (DTAC-100, BioAssay System, USA)

  Baseline (before randomization)

• Serum total anti-oxidant capacity (TAC)

  The concentration of the TAC level (Ta) using a commercialized kit (QuantiChromTM Antioxidant Assay Kit (DTAC-100, BioAssay System, USA)

  24 weeks after randomization

Secondary Outcomes (7)

• Intraocular pressure (IOP)

  Baseline (before randomization)

• Intraocular pressure (IOP)

  8 weeks after randomization

• Intraocular pressure (IOP)

  16 weeks after randomization

• Intraocular pressure (IOP)

  24 weeks after randomization

• Retinal nerve fiber layer thickness (RNFL)

  Baseline (before randomization)

Study Arms (2)

Rehabilitation group

ACTIVE COMPARATOR

This is the phase 3 of the entire research protocol. Phase 3 will be initiated once the phase 2 (development of rehabilitation module) is completed. A user friendly and inexpensive device and program with minimal usage of low vision aid will be designed and piloted. There are 3 different rehabilitation modules. A total of 300 primary glaucoma patients will be recruited and randomized using SNOSE: 150 intervention group and 150 non-intervention group. The intervention group will comprised of 150 primary glaucoma patients who will be assigned to different rehabilitation program: 1. navigation and mobility (50 patients) 2. physical activities including special exercise (50 patients) 3. reading (50 patients) There will be no patient who will be involved in more than one rehabilitation program at anytime.

Other: Visual rehabilitation module: navigation and mobility; Other: Visual rehabilitation module: exercise; Other: Visual rehabilitation module: reading

Non-rehabilititation group

NO INTERVENTION

Group of primary glaucoma patients who are not taught and practiced the new rehabilitation module for navigation, physical activity (exercise) and reading. They will be asked to continue their regular activities and provided with the similar reading material (book) to read daily.

Interventions

Visual rehabilitation module: navigation and mobility OTHER

The visual rehabilitation regime consist of education and activity include dressing, feeding, personal hygiene and grooming activities, functional mobility, room orientation and memory, reading, eye hand coordination and also optokinetic training programme. A diary will be given to assess their compliance. Reassessment based on the number of fall, stumble etc when they go through a maze (developed in Phase 1)will be done every 2weeks for 8 weeks (4 times), every 4 weeks for next 8 weeks (2 times) and the final assessment 8 weeks later. A total study intervention will be 24 weeks

Rehabilitation group

Visual rehabilitation module: exercise OTHER

An instruction course will be conducted and a CD (with step by step exercise demonstration) will be given to the patients in group A. They will be asked to come for another session in 2 weeks. Then they will be asked to conduct the exercise for at least three times a week for 24 weeks. Exercise diary and accelerometer will also be given to patients of both groups. They will be seen in the clinic every 8 weeks.

Rehabilitation group

Visual rehabilitation module: reading OTHER

Patient in intervention group will be asked to complete a reading task (reading the given book) a day, number of pages completed in an hour per day and time taken to complete a page in given book. They are asked to complete the books within 24 weeks with follow up every 8 weeks.

Rehabilitation group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known cases of POAG and PACG who are compliance to treatment and follow up
• Those who have more than 10 degree from fixation (based on Humphrey visual field)
• Best corrected visual acuity of 6/60 on the better seeing eye
• Pseudophakic or phakic (without visually significant cataract)

You may not qualify if:

• History of surgical intervention 3 months prior to recruitment
• Physical disabilities such as stroke, limbs amputation
• Severe hearing impairment
• Those with macular and retinal pathology
• Those already on low vision aids

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Ministry of Health, Malaysia: collaborator
• Universiti Teknologi Mara: collaborator

Study Sites (1)

Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

RECRUITING

Related Publications (19)

• Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.

  PMID: 24974815 RESULT

• Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014 May 14;311(18):1901-11. doi: 10.1001/jama.2014.3192.

  PMID: 24825645 RESULT

• 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 RESULT

• Turano KA, Rubin GS, Quigley HA. Mobility performance in glaucoma. Invest Ophthalmol Vis Sci. 1999 Nov;40(12):2803-9.

  PMID: 10549639 RESULT

• Viswanathan AC, McNaught AI, Poinoosawmy D, Fontana L, Crabb DP, Fitzke FW, Hitchings RA. Severity and stability of glaucoma: patient perception compared with objective measurement. Arch Ophthalmol. 1999 Apr;117(4):450-4. doi: 10.1001/archopht.117.4.450.

  PMID: 10206571 RESULT

• Izzotti A, Bagnis A, Sacca SC. The role of oxidative stress in glaucoma. Mutat Res. 2006 Mar;612(2):105-14. doi: 10.1016/j.mrrev.2005.11.001. Epub 2006 Jan 18.

  PMID: 16413223 RESULT

• Majsterek I, Malinowska K, Stanczyk M, Kowalski M, Blaszczyk J, Kurowska AK, Kaminska A, Szaflik J, Szaflik JP. Evaluation of oxidative stress markers in pathogenesis of primary open-angle glaucoma. Exp Mol Pathol. 2011 Apr;90(2):231-7. doi: 10.1016/j.yexmp.2011.01.001. Epub 2011 Jan 15.

  PMID: 21241689 RESULT

• Markowitz M. Occupational therapy interventions in low vision rehabilitation. Can J Ophthalmol. 2006 Jun;41(3):340-7. doi: 10.1139/I06-020.

  PMID: 16767190 RESULT

• 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 RESULT

• Nilsson UL. Visual rehabilitation of patients with advanced stages of glaucoma, optic atrophy, myopia or retinitis pigmentosa. Doc Ophthalmol. 1988 Dec;70(4):363-83. doi: 10.1007/BF00157066.

  PMID: 3266961 RESULT

• Chong Seong NT, Yaakub A, Jalil RA, Tirmandas Vn K, A/P Sandragasu T, Noor JBM, Husain NB, Mustari ZB, Hamid SAA, Mt Saad AB, At LS. Effect of physical activity on severity of primary angle closure glaucoma. Ther Adv Ophthalmol. 2019 Jul 29;11:2515841419864855. doi: 10.1177/2515841419864855. eCollection 2019 Jan-Dec.

  PMID: 31384724 RESULT

• Ramulu PY, Maul E, Hochberg C, Chan ES, Ferrucci L, Friedman DS. Real-world assessment of physical activity in glaucoma using an accelerometer. Ophthalmology. 2012 Jun;119(6):1159-66. doi: 10.1016/j.ophtha.2012.01.013. Epub 2012 Mar 2.

  PMID: 22386950 RESULT

• Ramulu P. Glaucoma and disability: which tasks are affected, and at what stage of disease? Curr Opin Ophthalmol. 2009 Mar;20(2):92-8. doi: 10.1097/ICU.0b013e32832401a9.

  PMID: 19240541 RESULT

• Ramulu PY, West SK, Munoz B, Jampel HD, Friedman DS. Glaucoma and reading speed: the Salisbury Eye Evaluation project. Arch Ophthalmol. 2009 Jan;127(1):82-7. doi: 10.1001/archophthalmol.2008.523.

  PMID: 19139345 RESULT

• Sacca SC, Izzotti A, Rossi P, Traverso C. Glaucomatous outflow pathway and oxidative stress. Exp Eye Res. 2007 Mar;84(3):389-99. doi: 10.1016/j.exer.2006.10.008. Epub 2006 Dec 29.

  PMID: 17196589 RESULT

• Salim S. Oxidative stress and psychological disorders. Curr Neuropharmacol. 2014 Mar;12(2):140-7. doi: 10.2174/1570159X11666131120230309.

  PMID: 24669208 RESULT

• Stelmack JA, Tang XC, Wei Y, Wilcox DT, Morand T, Brahm K, Sayers S, Massof RW; LOVIT II Study Group. Outcomes of the Veterans Affairs Low Vision Intervention Trial II (LOVIT II): A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Feb 1;135(2):96-104. doi: 10.1001/jamaophthalmol.2016.4742.

  PMID: 27978569 RESULT

• van Landingham SW, Willis JR, Vitale S, Ramulu PY. Visual field loss and accelerometer-measured physical activity in the United States. Ophthalmology. 2012 Dec;119(12):2486-92. doi: 10.1016/j.ophtha.2012.06.034. Epub 2012 Aug 11.

  PMID: 22892152 RESULT

• Wilkinson ME, Shahid KS. Low vision rehabilitation: An update. Saudi J Ophthalmol. 2018 Apr-Jun;32(2):134-138. doi: 10.1016/j.sjopt.2017.10.005. Epub 2017 Oct 27.

  PMID: 29942183 RESULT

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Motor Activity

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Liza Sharmini Ahmad Tajudin, Prof. Dr.

  Department of Ophthalmology, School of Medical Sciences, Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abd Hadi Mohd Rasidin, Dr

CONTACT

+60132506183; adi_insani@yahoo.com

Sarah Murniati Che Mat Nor, Dr

CONTACT

014-5213388

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Glaucoma Research, Principal Investigator

Study Record Dates

• First Submitted: November 28, 2020
• First Posted: February 3, 2021
• Study Start: October 1, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

MY (1)