UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007226 |
|---|---|
| Receipt number | R000008511 |
| Scientific Title | Department of Ophthalmology, Gifu University Graduate School of Medicine, Gifu, Japan |
| Date of disclosure of the study information | 2012/02/10 |
| Last modified on | 2015/02/05 20:16:42 |
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Basic information
Public title
Department of Ophthalmology, Gifu University Graduate School of Medicine, Gifu, Japan
Acronym
Intraocular pressure alterations after visual field testing
Scientific Title
Department of Ophthalmology, Gifu University Graduate School of Medicine, Gifu, Japan
Scientific Title:Acronym
Intraocular pressure alterations after visual field testing
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the intraocular pressure is significantly altered after visual field testing in eyes with open-angle glaucoma
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
intraocular pressure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Glaucoma
Key exclusion criteria
none
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Sawada |
Organization
Gifu University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-1 Yanagido, Gifu-shi , Japan.
TEL
058-230-5287
sawadaa-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Sawada |
Organization
Gifu University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
1-1 Yanagido, Gifu-shi , Japan.
TEL
058-230-5287
Homepage URL
sawadaa-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The baseline refractive error (spherical equivalent) was 4.13 +/- 3.61 diopters (D) in the right eye (OD) and 4.05 +/- 3.63 D in the left eye (OS). The average VF testing time was 7.5 +/- 1.4 minutes for both eyes. The average baseline IOP was 12.8 +/- 2.9 mmHg OD and 12.6 +/- 2.8 mmHg OS. After the VF testing of the right eye, the average IOP of the right eye decreased significantly to 12.3 +/- 2.6 mmHg (p = 0.001), but the IOP (12.5 +/- 2.6 mmHg) of the left eye was not significantly unchanged (p = 0.190). Following the VF testing of the left eye, the IOP in the right was 12.2 +/- 2.6 mmHg (p = 0.252) and that in the left eye was 12.4 +/- 2.7 mmHg (p = 0.487). An elevation of more than 2 mmHg in the IOP after the VF testing was found in 2.8% of the right eyes and 0.9% of the left eyes. The refractive error was not significantly changed after the VF testing. Multivariate analysis showed statistically significant correlations between the IOP decrease after the VF testing and the baseline IOP (p = 0.000) and the central corneal thickness (p = 0.034).
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
| 2008 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 03 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 03 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 03 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2012 | Year | 02 | Month | 04 | Day |
Last modified on
| 2015 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008511
