UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027660 |
|---|---|
| Receipt number | R000031686 |
| Scientific Title | Evaluation of ocular circulation after vitreous surgery for macular diseases. |
| Date of disclosure of the study information | 2017/06/07 |
| Last modified on | 2018/06/07 13:46:43 |
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Basic information
Public title
Evaluation of ocular circulation after vitreous surgery for macular diseases.
Acronym
Ocular circulation after macular surgery.
Scientific Title
Evaluation of ocular circulation after vitreous surgery for macular diseases.
Scientific Title:Acronym
Ocular circulation after macular surgery.
Region
| Japan |
Condition
Condition
Macular hoe, Epi-retinal membrane, Macular edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in ocular circulation pre and after vitreous surgery for macular diseases using laser speckle flowgraphy (LSFG).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the optic nerve head circulation using LSFG at pre, 1 month and 3month after vitreous surgery for macular disease.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Comparison of surgical times by multiple surgions.
Interventions/Control_2
Comparison of concentration of adrenaline in vitreous reflux fluid (0.3 ml, 0.5 ml, 1.0 ml) during vitreous surgery.
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
In patients with mauclar hole, epi-retinal membrane, macular edema.
Key exclusion criteria
In patients with severe cataract, history of any vitreous surgery, and arrhythmia.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Shiba |
Organization
School of Medicine, Toho University
Division name
Ophthalmology
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3761-4151
tomoaki-s@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Shiba |
Organization
School of Medicine, Toho University
Division name
Ophthalmology
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3761-4151
Homepage URL
tomoaki-s@med.toho-u.ac.jp
Sponsor or person
Institute
School of Medicine, Toho University
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2017 | Year | 06 | Month | 07 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 07 | Day |
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
| 2017 | Year | 06 | Month | 06 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031686
