UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000942 |
|---|---|
| Receipt number | R000001127 |
| Scientific Title | infection of chlamydia pneumoniae and normal-tension glaucoma |
| Date of disclosure of the study information | 2007/12/15 |
| Last modified on | 2009/06/09 10:17:37 |
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Basic information
Public title
infection of chlamydia pneumoniae and normal-tension glaucoma
Acronym
C.pneumoniae and glaucoma
Scientific Title
infection of chlamydia pneumoniae and normal-tension glaucoma
Scientific Title:Acronym
C.pneumoniae and glaucoma
Region
| Japan |
Condition
Condition
normal-tension glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigated the possibility of an association between exposure to C.pneumoniae infection and the risk of normal-tension glaucoma.
Basic objectives2
Others
Basic objectives -Others
We made a hypothesis that C.pneumoniae infection to the vessels of optic nerve head trigger cascade in target cells, leading to endothelial activation, inflammation, thrombosis, vascular dysregularion of the optic nerve circularion. And C.pneumoniae infection causes the decrease of ocular blood flow and glaucomatous optic neuropathy without a high intraocular pressure. We investigated the possibility of an association between exposure to C.pneumoniae infection and the risk of normal-tension glaucoma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
opticlal density unit measured by ElISA for C.pneumoniae antigen
Key secondary outcomes
Base
Study type
Observational
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive patients with newly diagnosed untreated normal tension glaucoma attending the Glaucoma clinic of Keio University Hospital.All subjects underwent a complete ophthalmic examination including best corrected visual acuity measurements, slit lamp biomicroscopy, pentacam corneal thickness evaluation (Oculus Inc, Germany), Goldmann applanation tonometry, gonioscopy, funduscopy, and optic disc evaluation with a 90-diopter lens (Zeiss, Tokyo, Japan). In addition, Humphrey visual field testing was conducted with a Humphrey field analysis using the 30-2 Swedish Interactive Threshold Algorithm Standard Strategy (Zeiss, Tokyo, Japan).Definite normal-tension glaucoma cases were required to meet the following criteria: 1)angles were open and not occludable in both eyes on the basis of gonioscopy, 2)visual field defects were present and consistent with glaucomatous optic neuropathy in the visual field tests, 3)All the IOPs measured by goldmann applanation tonometry at least twice at the day time were under 21 mmHg.
Key exclusion criteria
Subjects with other ophthalmic conditions such as angle closure glaucoma, pigment dispersion glaucoma, exfoliative glaucoma, trauma, any other type of secondary glaucoma, subjects with high myopia exceeding -10D or hyperopia below +3D, subjects below 40 or over 85 years of age, were excluded. None of these patients and controls had been taking steroids or immunosupressive agents. Other exclusion criteria for both groups were smoking and a history of any chronic systemic disease including diabetes mellitus, hypertension and auto-immune disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kenya yuuki |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
shinanomachi35,shinjyuku-ku,tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Department of Ophthalmology
Division name
glaucoma group
Zip code
Address
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
Keio University School of Medicine,Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology
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
Address
Tel
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
| 2007 | Year | 12 | Month | 15 | 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
Completed
Date of protocol fixation
| 2007 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
none
Management information
Registered date
| 2007 | Year | 12 | Month | 09 | Day |
Last modified on
| 2009 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001127
