Primary Open Angle Glaucoma Clinical Trial
— MaGESIIOfficial title:
Malay Glaucoma Eye Study II: Elucidating Navigation, Mobility and Reading Ability to Improve Quality of Life and Progression of Primary Glaucoma
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Known cases of POAG and PACG who are compliance to treatment and follow up 2. Those who have more than 10 degree from fixation (based on Humphrey visual field) 3. Best corrected visual acuity of 6/60 on the better seeing eye 4. Pseudophakic or phakic (without visually significant cataract) Exclusion Criteria: 1. History of surgical intervention 3 months prior to recruitment 2. Physical disabilities such as stroke, limbs amputation 3. Severe hearing impairment 4. Those with macular and retinal pathology 5. Those already on low vision aids |
Country | Name | City | State |
---|---|---|---|
Malaysia | Universiti Sains Malaysia | Kota Bharu | Kelantan |
Lead Sponsor | Collaborator |
---|---|
Universiti Sains Malaysia | Ministry of Health, Malaysia, Universiti Teknologi Mara |
Malaysia,
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;11:25158414198 — View Citation
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. Epub 2007 Nov 5. — View Citation
Izzotti A, Bagnis A, Saccà SC. The role of oxidative stress in glaucoma. Mutat Res. 2006 Mar;612(2):105-14. Epub 2006 Jan 18. Review. — View Citation
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.yex — View Citation
Markowitz M. Occupational therapy interventions in low vision rehabilitation. Can J Ophthalmol. 2006 Jun;41(3):340-7. Review. — View Citation
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. Epub 2007 Nov 12. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Saccà SC, Izzotti A, Rossi P, Traverso C. Glaucomatous outflow pathway and oxidative stress. Exp Eye Res. 2007 Mar;84(3):389-99. Epub 2006 Dec 29. Review. — View Citation
Salim S. Oxidative stress and psychological disorders. Curr Neuropharmacol. 2014 Mar;12(2):140-7. doi: 10.2174/1570159X11666131120230309. — View Citation
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 — View Citation
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 20 — View Citation
Turano KA, Rubin GS, Quigley HA. Mobility performance in glaucoma. Invest Ophthalmol Vis Sci. 1999 Nov;40(12):2803-9. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Navigation: completion of maze | Time to complete the maze (minutes) | Baseline (before randomization) | |
Primary | Navigation: completion of maze | Time to complete the maze (minutes) | 24 weeks after randomization | |
Primary | Navigation: number of obstacles | Number of stumbles and bumps while walking through the maze (number) | Baseline (before randomization) | |
Primary | Navigation: number of obstacles | Number of stumbles and bumps while walking through the maze (number) | 24 weeks after randomization | |
Primary | Mobility at home | Accelerometer reading (steps/day) | Baseline (before randomization) | |
Primary | Mobility at home | Accelerometer reading (steps/day) | 2 weeks after randomization | |
Primary | Mobility at home | Accelerometer reading (steps/day) | 4 weeks after randomization | |
Primary | Mobility at home | Accelerometer reading (steps/day) | 8 weeks after randomization | |
Primary | Mobility at home | Accelerometer reading (steps/day) | 16 weeks after randomization | |
Primary | Mobility at home | Accelerometer reading (steps/day) | 24 weeks after randomization | |
Primary | Physical activity and exercise | Accelerometer reading of moderate-vigorous physical activity (MVPA) (number) | Baseline (before randomization) | |
Primary | Physical activity and exercise | Accelerometer reading of moderate-vigorous physical activity (MVPA) (number) | 2 weeks after randomization | |
Primary | Physical activity and exercise | Accelerometer reading of moderate-vigorous physical activity (MVPA) (number) | 4 weeks after randomization | |
Primary | Physical activity and exercise | Accelerometer reading of moderate-vigorous physical activity (MVPA) (number) | 8 weeks after randomization | |
Primary | Physical activity and exercise | Accelerometer reading of moderate-vigorous physical activity (MVPA) (number) | 16 weeks after randomization | |
Primary | Physical activity and exercise | Accelerometer reading of moderate-vigorous physical activity (MVPA) (number) | 24 weeks after randomization | |
Primary | Reading speed of near vision chart | Number of words per minute | Baseline (before randomization | |
Primary | Reading speed of near vision chart | Number of words per minute | 24 weeks after randomization | |
Primary | Reading speed of the provided materials (prescription label and newspaper) | Number of words per minute | Baseline (before randomization) | |
Primary | Reading speed of the provided materials (prescription label and newspaper) | Number of words per minute | 24 weeks after randomization | |
Primary | Reading speed of the given book | Number of pages per hour | Baseline (before randomization) | |
Primary | Reading speed of the given book | Number of pages per hour | 8 weeks after randomization | |
Primary | Reading speed of the given book | Number of pages per hour | 16 weeks after randomization | |
Primary | Reading speed of the given book | Number of pages per hour | 24 weeks after randomization | |
Primary | 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) | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | |
Primary | 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) | |
Primary | 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 | Intraocular pressure (IOP) | Measurement of intraocular pressure (mmHg) using Goldman Applanation Tonometry(Haag-Street International, UK) | Baseline (before randomization) | |
Secondary | Intraocular pressure (IOP) | Measurement of intraocular pressure (mmHg) using Goldman Applanation Tonometry(Haag-Street International, UK) | 8 weeks after randomization | |
Secondary | Intraocular pressure (IOP) | Measurement of intraocular pressure (mmHg) using Goldman Applanation Tonometry(Haag-Street International, UK) | 16 weeks after randomization | |
Secondary | Intraocular pressure (IOP) | Measurement of intraocular pressure (mmHg) using Goldman Applanation Tonometry(Haag-Street International, UK) | 24 weeks after randomization | |
Secondary | Retinal nerve fiber layer thickness (RNFL) | Measurement of RNFL thickness (mm) using HD Cirrus Optical Coherent Tomography (Carl Zeiss) Mesurement of RNFL thickness using HD Cirrus Optical Coherent Tomography (Carl Zeiss, US) | Baseline (before randomization) | |
Secondary | Retinal nerve fiber layer thickness (RNFL) | Measurement of RNFL thickness (mm) using HD Cirrus Optical Coherent Tomography (Carl Zeiss) Mesurement of RNFL thickness using HD Cirrus Optical Coherent Tomography (Carl Zeiss, US) | 8 weeks after randomization | |
Secondary | Retinal nerve fiber layer thickness (RNFL) | Measurement of RNFL thickness (mm) using HD Cirrus Optical Coherent Tomography (Carl Zeiss) Mesurement of RNFL thickness using HD Cirrus Optical Coherent Tomography (Carl Zeiss, US) | 24 weeks after randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05564091 -
Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma
|
N/A | |
Recruiting |
NCT02792803 -
A Comparison of Xalatan (Latanoprost) to Apo-latanoprost and Co-latanoprost in the Treatment of Glaucoma
|
Phase 4 | |
Terminated |
NCT02801617 -
Non-inferiority of PRO-067 Ophthalmic Solution vs GAAP Ofteno® in Glaucoma or Ocular Hypertension
|
Phase 3 | |
Completed |
NCT01384149 -
EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA
|
Phase 1 | |
Completed |
NCT00300079 -
Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension
|
Phase 4 | |
Enrolling by invitation |
NCT00221923 -
African Descent and Glaucoma Evaluation Study
|
||
Recruiting |
NCT05605743 -
Alternate Nostril Breathing Training in Geriatrics With Glaucoma and High Blood Pressure
|
N/A | |
Completed |
NCT04828057 -
Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting
|
||
Completed |
NCT01442896 -
STudy to Assess Rapid Disease Progression by Clinical and Genetic Factors In Glaucoma patientS That Are High Risk
|
||
Enrolling by invitation |
NCT05557721 -
Uddevalla Skövde Transscleral Micropulse Study
|
||
Recruiting |
NCT04595227 -
Glaucoma Screening Using Dynamic Analysis of Computerized Pupillary Light Reflex Assessment Device
|
||
Terminated |
NCT04141865 -
Effect of Xen Implantation on the Aqueous Humor Proteome
|
||
Completed |
NCT01979913 -
An Open, Non-randomized Pilot Study on the Effect of Preservative Free Tafluprost (Saflutan® Augentropfen) in Patients With Ocular Hypertension or Primary Open Angle Glaucoma With an Uncontrolled Intraocular Pressure of 30 mmHg and More
|
Phase 4 | |
Completed |
NCT01943721 -
A Study of the VISION5 Product in Patients With Glaucoma or Ocular Hypertension
|
Phase 1 | |
Completed |
NCT02023242 -
Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
|
N/A | |
Completed |
NCT01769521 -
Relationship Between 24-hour IOP Pattern and the 24-hour Blood Pressure Pattern in Patients With POAG
|
N/A | |
Not yet recruiting |
NCT01711177 -
Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma
|
N/A | |
Recruiting |
NCT00773123 -
Efficacy of Retinal Nerve Fiber Layer (RNFL) / Ganglion Cell Layer Thickness Ratio by RT-View Utilizing Spectral -Domain Technology as a Diagnostic Predictor of Glaucoma.
|
N/A | |
Recruiting |
NCT00773877 -
Comparison of Retinal Nerve Fiber Layer (RNFL) Thickness Measurements by Time-Domain and Spectral-Domain OCT In Glaucoma Patients
|
N/A | |
Completed |
NCT02544646 -
Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG
|
N/A |