UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051944 |
|---|---|
| Receipt number | R000059281 |
| Scientific Title | Study of alcohol and ocular blood flow in patients with normal tension glaucoma |
| Date of disclosure of the study information | 2023/08/23 |
| Last modified on | 2023/08/23 12:42:19 |
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Basic information
Public title
Study of alcohol and ocular blood flow in patients with normal tension glaucoma
Acronym
Study of alcohol and ocular blood flow in patients with normal tension glaucoma
Scientific Title
Study of alcohol and ocular blood flow in patients with normal tension glaucoma
Scientific Title:Acronym
Study of alcohol and ocular blood flow in patients with normal tension glaucoma
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Before and after drinking alcoholic and non-alcoholic beverages, normal-tension glaucoma patients underwent ocular blood flow measurements using LSFG, ophthalmologic examinations, and whole-body examinations, and examined whether there was a difference in ocular fundus blood flow changes from that in healthy controls. Consider the effect of alcohol on the fundus.
Basic objectives2
Others
Basic objectives -Others
ocular blood flow
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences between normal-tension glaucoma and healthy subjects in parameters obtained by LSFG and other ophthalmologic examinations
Key secondary outcomes
Blood pressure, pulse, intraocular pressure, skin blood flow, nail bed capillary examination
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
beer intake
Take 20g of pure alcohol in about 10 minutes.
Interventions/Control_2
Drinking non-alcoholic beer
Consume within 10 minutes.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Name of disease: Patients with normal tension glaucoma
2. Disease stage, stage Early to mid-term
3. Age 20 years old or older, 60 years old or younger (at the time of registration)
4. Gender 10 men and 100 women in each group
Key exclusion criteria
1. Those who show alcohol intolerance in the alcohol questionnaire and alcohol patch test
2. Those who have serious dysphagia and have difficulty in drinking alcohol
3. Alcoholics and drug addicts
4. Those who have received corticosteroids within 1 month
5. Those who are taking oral medicines that affect lifestyle-related diseases and hemodynamics
6. People with liver disease or gastrointestinal disorder
7. Eye drops that are expected to affect ocular circulation (b-blockers, a-agonists, etc.)
8. Those who have been diagnosed with angle-closure glaucoma and have difficulty with mydriasis
9. Those who cannot perform a visual field test or OCT, or those who cannot see through the fundus with SLO due to difficulty in fundus examination.
10. Those with severe visual impairment (requires assistance in daily life due to visual impairment)
11. Those who are judged by the principal investigator or co-investigator to be unsuitable for participating in the research
12. Pregnant women, breastfeeding women, and those who wish to become pregnant during the research period
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai,Miyagi 980-8574,Japan
TEL
022-717-7294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai,Miyagi 980-8574,Japan
TEL
022-717-7294
Homepage URL
ishikawa-m@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi 980-8574, Japa
Tel
022-717-3867
med-kenkyo@grp.tohoku.ac.jp
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
| 2023 | Year | 08 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059281
