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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000016897 |
Receipt No. | R000017495 |
Scientific Title | Examination of eye diseases with adaptive optics scanning laser ophthalmoscopy |
Date of disclosure of the study information | 2015/03/24 |
Last modified on | 2015/03/24 |
Basic information | ||
Public title | Examination of eye diseases with adaptive optics scanning laser ophthalmoscopy | |
Acronym | AO-SLO for eye diseases | |
Scientific Title | Examination of eye diseases with adaptive optics scanning laser ophthalmoscopy | |
Scientific Title:Acronym | AO-SLO for eye diseases | |
Region |
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Condition | ||
Condition | Diabetic retinopathy, age-related macular degeneration, retinitis pigmentosa, the other retinal diseases | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine photoreceptor and retinal blood vessels in retinal diseases with AO-SLO |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Correlation between cone mosaic, dynamic state of blood flow and visual function in retinal dieases |
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 | Diagnosis | |
Type of intervention |
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Interventions/Control_1 | Adaptive Optics Scanning Laser Ophthalmoscopy | |
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)Patient group: Patients with diabetes retinopathy, age related macular degeneration, retina pigment denaturation, other retina diseases in Kyushu University Hospital ophthalmology.
Control group: Person who do not have any retinal disease in Kyushu University Hospital ophthalmology, and there is not the systemic disease including diabetes and hypertension. (2) Person who can understand this study plan enough, and the agreement by the person is possible. (3) Age at the time of the agreement acquisition; one 20 years or older. |
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Key exclusion criteria | (1) Person with the past which is a side effect (hyperesthesia and the eyes pressure rise) to mydriasis eye drop.
(2) Person with shallow anterior chamber (3) Person who id judged that he is not suitable as a subject by a researcher. |
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Target sample size | 220 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyushu University | ||||||
Division name | Ophthalmology | ||||||
Zip code | |||||||
Address | 3-1-1 Maidashi Higashi-ku Fukuoka | ||||||
TEL | 81-92-642-5648 | ||||||
snakao@med.kyushu-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyushu University | ||||||
Division name | Department of Ophthalmology | ||||||
Zip code | |||||||
Address | 3-1-1 Maidashi Higashi-ku Fukuoka | ||||||
TEL | 81-92-642-5648 | ||||||
Homepage URL | |||||||
snakao@med.kyushu-u.ac.jp |
Sponsor | |
Institute | Kyushu University |
Institute | |
Department |
Funding Source | |
Organization | JSPS KAKENHI, Grant-in-Aid for Young Scientists (A) No. 25713057 |
Organization | |
Division | |
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Other related organizations | |
Co-sponsor | Canon Inc. |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 | Enrolling by invitation | ||||||
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 of closure to data entry |
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Date trial data considered complete | |||||||
Date analysis concluded |
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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=R000017495 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |