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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000027826 |
Receipt No. | R000031835 |
Scientific Title | Effect of brimonidine on the ocular circulation |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2017/06/19 |
Basic information | ||
Public title | Effect of brimonidine on the ocular circulation | |
Acronym | Effect of brimonidine on the ocular circulation | |
Scientific Title | Effect of brimonidine on the ocular circulation | |
Scientific Title:Acronym | Effect of brimonidine on the ocular circulation | |
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 | To evaluate the effect of brimonidine on the ocular circulation |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Retinal blood flow |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Measurement of the retinal blood flow by Doppler optical coherence tomography (DOCT)
(Before start brimonidine and 3 months after start brimonidine) |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Subjects able to understand the written informed consent and willing to participate evidenced by signing the informed consent
2)Glaucomatous changes in the fundus 3)Abnormal glaucomatous visual field according to the Anderson-Patella classification in the Swedish interactive threshold algorithm (SITA)-standard strategy of the 30-2 program of the Humphrey field analyzer (HFA) 4)Subjects administered with additional brimonidine |
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Key exclusion criteria | 1)Cataract and previous cataract surgery
2)High ametropia 3)Subjects with cardiovascular disease such as untreated hypertension and diabetes mellitus 4)Previous ocular surgery 5)Difficulty for perform examination |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Asahikawa Medical University | ||||||
Division name | Ophthalmology | ||||||
Zip code | |||||||
Address | 2-1-1-1 Midorigaoka Higashi Asahikawa, Hokkaido, Japan | ||||||
TEL | 0166-68-2543 | ||||||
nby@asahikawa-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Asahikawa Medical University | ||||||
Division name | Ophthalmology | ||||||
Zip code | |||||||
Address | 2-1-1-1 Midorigaoka Higashi Asahikawa, Hokkaido, Japan | ||||||
TEL | 0166-68-2543 | ||||||
Homepage URL | |||||||
t-kamiya@asahikawa-med.ac.jp |
Sponsor | |
Institute | Asahikawa Medical University |
Institute | |
Department |
Funding Source | |
Organization | Asahikawa Medical University |
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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
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=R000031835 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |