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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001554 |
Receipt No. | R000001879 |
Scientific Title | Investigation of the anterior eye by polarization sensitive optical coherence tomography |
Date of disclosure of the study information | 2008/12/05 |
Last modified on | 2009/12/07 |
Basic information | ||
Public title | Investigation of the anterior eye by polarization sensitive optical coherence tomography | |
Acronym | Polarization sensitive OCT of anterior eye | |
Scientific Title | Investigation of the anterior eye by polarization sensitive optical coherence tomography | |
Scientific Title:Acronym | Polarization sensitive OCT of anterior eye | |
Region |
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Condition | ||
Condition | Glaucoma | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Investigate the image contrasts of the tissues in the anterior eye by polarization sensitive optical coherence tomography |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I,II |
Assessment | |
Primary outcomes | The visibility of individual tissues in PSOCT images are graded by multiple graders with discrete score levels. |
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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The subjects who were explained about this study and then agreed with this study.
The subject may contain normal healthy subjects, subjects who are suffered by anterior and or posterior eye disorders. |
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Key exclusion criteria | The subjects without informed consent will be rejected from this study. | |||
Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | University of Tsukuba | ||||||
Division name | Institute of Applied Physics | ||||||
Zip code | |||||||
Address | Tennodai 1-1-1, Tsukuba, Ibaraki, Japan | ||||||
TEL | 029-853-5217 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | University of Tsukuba | ||||||
Division name | Institute of Applied Physics | ||||||
Zip code | |||||||
Address | Tennodai 1-1-1, Tsukuba, Ibaraki, Japan | ||||||
TEL | 029-853-5217 | ||||||
Homepage URL | |||||||
yasuno@optlab2.bk.tsukuba.ac.jp |
Sponsor | |
Institute | University of Tsukuba |
Institute | |
Department |
Funding Source | |
Organization | Japan Science and Technology Agency |
Organization | |
Division | |
Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Tokyo medical university |
Name of secondary funder(s) | Tomey Corporation |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | The visibility of trabecular meshwork is significantly improved by PSOCT in comparison to that of standard OCT. (Optics and Photonics Japan 2008) |
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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information | A trabecular meshwork is visualized as a bending pattern in the phase retardation optical coherence tomography images.
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001879 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |