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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040351
Receipt No. R000046045
Scientific Title Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
Date of disclosure of the study information 2020/05/10
Last modified on 2020/05/10

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Basic information
Public title Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
Acronym Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
Scientific Title Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
Scientific Title:Acronym Inhaled corticosteroid as a risk of glaucoma: systematic review and meta-analysis
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Pneumology Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Inhaled corticosteroid (ICS) has been accepted as the first-choice treatment option for stable asthma and asthma chronic obstructive pulmonary disease overlap (ACO)[GINA2020, GINA-GOLD2017]. Corticosteroid, which is directly delivered to the airway via inhaler devices, effectively ameliorates inflammation of the respiratory system. Compared to oral corticosteroids, ICS cause less systemic side effect since small portion of ICS is absorbed into systemic circulation. Nonetheless, some systemic adverse events were recognized including hypothalamic-pituitary-adrenal axis, decreased bone mineral density, and dermal thinning[PMID 10326936]. Attention should be also pay for ocular effects such as cataract and glaucoma. Regarding cataract, two meta-analyses published in 2006 and 2009 consistently revealed that ICS treatment resulted in increased risk of cataract [PMID 19740259, 16671966]. Regarding glaucoma, a large-scale case control study with 9793 patients and 38325 controls by Garbe et al. showed that prolonged administration of high doses of inhaled glucocorticoids increased the risk of ocular hypertension or open-angle glaucoma[PMID: 9042844]. Their report raised a serious concern for physicians who take care of patients with asthma and ACO since glaucoma is a lifelong eye disease that can lead to vision loss if not controlled. However, many subsequent researches did not confirm the link between ICS and glaucoma. Furthermore, no meta-analysis that assessed how ICS impacts on risk of glaucoma and ocular hypertension has been published. This systematic review and meta-analysis aimed to evaluate whether ICS increases the risk of glaucoma and increased intraocular pressure (IOP).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome was glaucoma frequency in the form of an unadjusted odds ratio (OR) between ICS and non-ICS population.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria In a case-control studies, cases should have glaucoma. Glaucoma need not be specified as open-angle, closed-angle, or normal-tension glaucoma.
In a cohort study and an RCT, ICS-treated patients with any respiratory diseases including asthma and ACO may be included. No limitation was set for dosage, frequency, or timing of ICS-treatment.
Key exclusion criteria None
Target sample size

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name city
Last name Horita
Organization Yokohama City University School of Medicine
Division name Department of Pulmonology
Zip code 236-0032
Address 3-9 fukuura kanazawaku
TEL 0457872700
Email horitano@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Horita
Organization Yokohama City University School of Medicine
Division name Department of Pulmonology
Zip code 236-0004
Address 3-9 fukuura kanazawaku yokohama
TEL 0457872800
Homepage URL
Email horitano@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization not applicable
Address not applicable
Tel not applicable
Email not applicable

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2020 Year 05 Month 10 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study search
We willsearch for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection on May 10th, 2020.

Publication type
Case-control studies, cohort studies, and randomized controlled trials will be included when each study provided data to compare glaucoma frequencies between ICS and non-ICS population in the form of odds ratio (OR).
Studies that offered information concerning only the secondary endpoints will be also included.
Non-English language article and conference abstract were allowed.

Treatment
ICS with any type of inhaler device and any type of glucocorticoid will be allowed. If patients in ICS arm are simultaneously administered muscarine antagonist, the patients in non-ICS arm should be also treated with the same muscarine antagonist because muscarine antagonist is a known cause of glaucoma.

Primary outcome
The primary outcome will be glaucoma frequency in the form of an unadjusted odds ratio (OR) between ICS and non-ICS population.

Secondary outcome.
The secondary outcomes includes (i) glaucoma frequency in the form of adjusted odds ratio (OR) between ICS and non-ICS population, (ii) intraocular pressure (IOP) change from the baseline, mmHg mean, difference (MD), (iii) single-measured IOP, mmHg, MD.

Quality assessment
Newcastle-Ottawa Scale (NOS) will be used to assess the risk of bias of each study.

Subgroup analysis
Subgroup analysis based on study designs will be conducted.


Management information
Registered date
2020 Year 05 Month 10 Day
Last modified on
2020 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046045

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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