- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05278299
Asia Glaucoma Registry
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Glaucoma remains a leading cause for irreversible visual impairment and blindness worldwide and it disproportionately affects people residing in Asia [Tham et al, 2014]. It is well established that the epidemiology and natural history of glaucoma in patients in the Asia region is different from its western counterparts. Compared with the other parts of the world, the prevalence of primary angle closure glaucoma (PACG) was highest in Asia [Tham et al, 2014]. The prevalence of PACG was higher in East Asia than South East Asia, while the burden of primary open angle glaucoma (POAG) was projected to be the highest in South-Central Asia by 2040 [Chan et al, 2016]; this suggests that ethnic differences within Asia may be a contributing factor to the differences in the prevalence of different types of glaucoma. Furthermore, studies have suggested the prevalence of normal pressure glaucoma is also higher in Asians than Caucasians [ Chen et al , 2020 ] Given the disproportionate burden of glaucoma in Asia, there is a need to ensure optimal management of the disease in patients with glaucoma. The ability to estimate the rates of structural and functional loss in patients with glaucoma will enable clinicians to identify those with rapidly deteriorating conditions or those at-risk, and to therefore provide timely treatment to these patients.
Despite this, there are currently several challenges in identifying rapid-progressors in glaucoma, including lack of consensus on the definition of 'rapid' progression and what rates of change of visual field (VF) encompass clinically significant deterioration relevant to the patients. As such, the Asia Glaucoma Registry is intended to collect data to advance the understanding of glaucoma and its progression in Asia and to understand the management patterns of glaucoma in Asia. The Registry will also provide research data for future collaborative scientific research projects. Glaucoma remains a leading cause for irreversible visual impairment and blindness worldwide and it disproportionately affects people residing in Asia [Tham et al, 2014]. It is well established that the epidemiology and natural history of glaucoma in patients in the Asia region is different from its western counterparts. Compared with the other parts of the world, the prevalence of primary angle closure glaucoma (PACG) was highest in Asia [Tham et al, 2014]. The prevalence of PACG was higher in East Asia than South East Asia, while the burden of primary open angle glaucoma (POAG) was projected to be the highest in South-Central Asia by 2040 [Chan et al, 2016]; this suggests that ethnic differences within Asia may be a contributing factor to the differences in the prevalence of different types of glaucoma. Furthermore, studies have suggested the prevalence of normal pressure glaucoma is also higher in Asians than Caucasians [ Chen et al , 2020 ] Given the disproportionate burden of glaucoma in Asia, there is a need to ensure optimal management of the disease in patients with glaucoma. The ability to estimate the rates of structural and functional loss in patients with glaucoma will enable clinicians to identify those with rapidly deteriorating conditions or those at-risk, and to therefore provide timely treatment to these patients.
Despite this, there are currently several challenges in identifying rapid-progressors in glaucoma, including lack of consensus on the definition of 'rapid' progression and what rates of change of visual field (VF) encompass clinically significant deterioration relevant to the patients. As such, the Asia Glaucoma Registry is intended to collect data to advance the understanding of glaucoma and its progression in Asia and to understand the management patterns of glaucoma in Asia. The Registry will also provide research data for future collaborative scientific research projects.
References:
Chan EW, et al. Glaucoma in Asia: regional prevalence variations and future projections. Br J Opthalmol 2016;100(1):78-85.
Chen MJ. Normal tension glaucoma in Asia : Epidemiology, pathogenesis, diagnosis, and management. Taiwan J Ophthalmo ;10 250-4. He M, et al. Angle-closure glaucoma in East Asian and European people. Different diseases? Eye (Lond) 2006;20(1):3-12.
Tham Y, et al. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and metaanalysis. Ophthalmology 2014;121(11):2081-90.
Yip JLY, Foster PJ. Ethnic differences in primary angle-closure glaucoma. Curr Opin Ophthalmol 2006;17(2):175-80.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
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Hong Kong, Hong Kong
- Leung Kai Shun
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients with a diagnosis of POAG or PACG
- Age ≥18 years at diagnosis.
- Have reliable VF tests obtained from Humphrey Field Analyzer (HFA) using the same testing strategy on average once a year over 6-7 years backward in at least one eye (the included eye must have evidence of glaucoma as defined above). A reliable VF test has fixation losses ≤20% and false positive errors ≤15%. All criteria mentioned above must be met for inclusion into the study. Both eyes will be included if both eyes meet the inclusion criteria.
Exclusion Criteria:
- Secondary causes of glaucoma (e.g. uveitic glaucoma, neovascular glaucoma, traumatic glaucoma, exfoliative glaucoma, pigmentary glaucoma, phacomorphic glaucoma, malignant glaucoma)
- Any neurological disease that may result in VF loss (e.g. stroke)
- History of optic neuropathy other than glaucoma (including those related to thyroid eye disease);
- Prior retinal surgery.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The proportion of fast progressors among patients with POAG or PACG and the risk factors for fast progression
Tidsramme: 1 year
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1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The severity and spectrum of glaucoma in different ethnic groups in Asia and the practice patterns of glaucoma management in Asia
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kai Shun, Christopher Leung, The University of Hong Kong
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UW 21-664
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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