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临床试验/NCT04736264
NCT04736264Unknown不适用

Malay Glaucoma Eye Study II: Elucidating Navigation, Mobility and Reading Ability to Improve Quality of Life and Progression of Primary Glaucoma

Universiti Sains Malaysia1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Navigation: completion of maze

研究概览

简要总结

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.

详细描述

Objectives General objective: to develop, validate and evaluate the effectiveness of navigation, physical activities and reading abilities (the new rehabilitation protocols) in Malay adults with primary glaucoma.

Specific objectives:

  1. To identify problems with navigation, physical activities and reading in Malay adults with primary glaucoma
  2. To develop and validate the new rehabilitation protocols for patients with primary glaucoma
  3. To evaluate the effectiveness of the new rehabilitation protocols in improving the quality of life of primary glaucoma patients
  4. To evaluate the mean changes of total antioxidant level pre- and post-intervention with the new rehabilitation protocols in primary glaucoma patients
  5. To evaluate the changes of ocular parameters pre- and post-intervention with the new rehabilitation protocols in primary glaucoma patients Research design

This research project will be divided into 3 phases with different research designs:

Phase 1: case control study on factors affecting navigation, physical activities and reading between primary glaucoma patients and age matched controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Visual rehabilitation module: navigation and mobility (Other)

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.

干预措施: Visual rehabilitation module: exercise (Other)

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.

干预措施: Visual rehabilitation module: reading (Other)

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.

结局指标

主要结局

Navigation: completion of maze

时间窗: 24 weeks after randomization

Time to complete the maze (minutes)

Reading speed of near vision chart

时间窗: 24 weeks after randomization

Number of words per minute

Navigation: number of obstacles

时间窗: 24 weeks after randomization

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

Physical activity and exercise

时间窗: 24 weeks after randomization

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

Reading speed of the given book

时间窗: 24 weeks after randomization

Number of pages per hour

Serum total anti-oxidant capacity (TAC)

时间窗: 24 weeks after randomization

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

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

时间窗: 24 weeks after randomization

Number of words per minute

Depression score

时间窗: 24 weeks after randomization

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

Mobility at home

时间窗: 24 weeks after randomization

Accelerometer reading (steps/day)

Quality of life score

时间窗: 24 weeks after randomization

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

Navigation: completion of maze

时间窗: Baseline (before randomization)

Time to complete the maze (minutes)

Navigation: number of obstacles

时间窗: Baseline (before randomization)

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

Mobility at home

时间窗: Baseline (before randomization)

Accelerometer reading (steps/day)

Mobility at home

时间窗: 2 weeks after randomization

Accelerometer reading (steps/day)

Mobility at home

时间窗: 4 weeks after randomization

Accelerometer reading (steps/day)

Mobility at home

时间窗: 8 weeks after randomization

Accelerometer reading (steps/day)

Mobility at home

时间窗: 16 weeks after randomization

Accelerometer reading (steps/day)

Physical activity and exercise

时间窗: Baseline (before randomization)

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

Physical activity and exercise

时间窗: 2 weeks after randomization

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

Physical activity and exercise

时间窗: 4 weeks after randomization

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

Physical activity and exercise

时间窗: 8 weeks after randomization

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

Physical activity and exercise

时间窗: 16 weeks after randomization

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

Reading speed of near vision chart

时间窗: Baseline (before randomization

Number of words per minute

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

时间窗: Baseline (before randomization)

Number of words per minute

Reading speed of the given book

时间窗: Baseline (before randomization)

Number of pages per hour

Reading speed of the given book

时间窗: 8 weeks after randomization

Number of pages per hour

Reading speed of the given book

时间窗: 16 weeks after randomization

Number of pages per hour

Quality of life score

时间窗: Baseline (before randomization)

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

Depression score

时间窗: Baseline (before randomization)

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

Serum total anti-oxidant capacity (TAC)

时间窗: Baseline (before randomization)

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

次要结局

  • Retinal nerve fiber layer thickness (RNFL)(24 weeks after randomization)
  • Intraocular pressure (IOP)(24 weeks after randomization)
  • Intraocular pressure (IOP)(Baseline (before randomization))
  • Intraocular pressure (IOP)(8 weeks after randomization)
  • Intraocular pressure (IOP)(16 weeks after randomization)
  • Retinal nerve fiber layer thickness (RNFL)(Baseline (before randomization))
  • Retinal nerve fiber layer thickness (RNFL)(8 weeks after randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liza Sharmini Ahmad Tajudin

Professor, Head of Glaucoma Research, Principal Investigator

Universiti Sains Malaysia

研究点 (1)

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