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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039255
Receipt No. R000044767
Scientific Title Prognostic value of Hutchinson's sign for ocular complications in herpes zoster ophthalmicus: a systematic review and meta-analysis
Date of disclosure of the study information 2020/01/29
Last modified on 2020/07/25

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Basic information
Public title Prognostic value of Hutchinson's sign for ocular complications in herpes zoster ophthalmicus: a systematic review and meta-analysis
Acronym Prognostic value of Hutchinson's sign for ocular complications in herpes zoster ophthalmicus: a systematic review and meta-analysis
Scientific Title Prognostic value of Hutchinson's sign for ocular complications in herpes zoster ophthalmicus: a systematic review and meta-analysis
Scientific Title:Acronym Prognostic value of Hutchinson's sign for ocular complications in herpes zoster ophthalmicus: a systematic review and meta-analysis
Region
Japan

Condition
Condition herpes zoster ophthalmicus
Classification by specialty
Medicine in general Ophthalmology Dermatology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This systematic review and meta-analysis aimed to investigate the prognostic value of Hutchinson's sign for ocular complications of herpes zoster ophthalmicus.
Basic objectives2 Others
Basic objectives -Others N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of ocular involvement, defined as a sign of ocular manifestation (e.g. conjunctivitis, superficial keratitis, episcleritis, stromal keratitis, dendritic ulcer, scleritis, uveitis, vasculitis, optic neuritis, chorioretinitis, acute retinal necrosis).

Time point for analysis will be defined as 4 weeks or the closest time point to 4 weeks in a time span of 2 weeks to 6 months if data are not available.
Key secondary outcomes Occurrence of severe ocular involvement (intraocular involvement: e.g. scleritis, uveitis, vasculitis, optic neuritis, chorioretinitis, acute retinal necrosis)

Time point for analysis will be defined as 4 weeks or the closest time point to 4 weeks in a time span of 2 weeks to 6 months if data are not available.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria were as follows: published and unpublished observational studies with a control, or controlled clinical studies, including only Abstracts or Letters; studies in any language, from any country, and including length of follow-up; and outpatients or inpatients suspected or diagnosed with acute herpes zoster ophthalmicus.
Key exclusion criteria Exclusion criteria were as follows: case reports and case series; children and patients with existing uveitis, glaucoma, corneal, and retinal diseases.
Target sample size 0

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Mizuta
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Dermatology
Zip code 1838524
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL +81423235111
Email t.miz.cof.lif2120@gmail.com

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Mizuta
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Dermatology
Zip code 1838524
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL +81423235111
Homepage URL
Email t.miz.cof.lif2120@gmail.com

Sponsor
Institute SRWS-PSG
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization N/A
Address N/A
Tel N/A
Email N/A

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 01 Month 29 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 01 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2022 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information [Search method]
Electronic search
MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL)

Other resources
World Health Organization International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov

Guidelines
1. European consensus-based (S2k) guideline on the management of Herpes Zoster - guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV), Part 1: Diagnosis.
2. International Association for the Study of Pain (IASP) recommendations on management of herpes zoster

We will search for references in identified articles, and relevant authors will be contacted, if information is insufficient in the reports.

[Data extraction / Risk of bias assessment]
Two authors will independently extract data and assess risk of bias using the QUIPS tool (Hayden 2013).

[Meta-analysis]
We will implement using STATA. We will use random effects model.

We will create a "Summary of findings" table and will use the grades of recommendation, assessment, development, and evaluation (GRADE) approach to grade the certainty of the evidence.

We will include the following outcomes in the "Summary of findings" table:
1. Occurrence of ocular involvement
2. Ocular involvement: uveitis

[Subgroup analysis]
Perform the following subgroup analyses:
1. Patients' immune competence (HIV infection absent or present)
2. Point of first contact (up to and including 72 h from the onset of rash or longer than 72 h from the onset of rash)
3. Point of starting initial systemic antiviral drugs (up to and including 72 h from the first patient contact or longer than 72 h from the first patient contact)

[Sensitivity analysis]
Perform the following sensitivity analyses for the primary outcome:
1. Exclusion of unpublished studies (full reports versus Abstracts or unpublished articles)
2. Exclusion of studies defining Hutchinson's sign as the presence of rash only on the tip of the nose

Management information
Registered date
2020 Year 01 Month 25 Day
Last modified on
2020 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044767

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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