UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039255 |
|---|---|
| Receipt number | 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 12:30:27 |
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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
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
t.miz.cof.lif2120@gmail.com
Sponsor or person
Institute
SRWS-PSG
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044767
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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