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

NCT04736264 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-02-03

No results posted yet for this study

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

Interventions

OTHER

Visual rehabilitation module: navigation and mobility

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

OTHER

Visual rehabilitation module: exercise

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.

OTHER

Visual rehabilitation module: reading

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.

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    collaborator OTHER_GOV
  • Universiti Teknologi Mara

    collaborator OTHER
  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Liza Sharmini Ahmad Tajudin, Prof. Dr. · Department of Ophthalmology, School of Medical Sciences, Universiti Sains Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04736264 on ClinicalTrials.gov