UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000040351
Receipt number	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	2021/12/20 12:23:37

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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

Glaucoma

Classification by specialty

Pneumology Ophthalmology

Classification by malignancy

Others

Genomic information

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 or person

Institute

Yokohama City University School of Medicine

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Published

Result