UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035703 |
|---|---|
| Receipt number | R000040605 |
| Scientific Title | Posterior Vitreous Detachment of healthy young eyes by Swept source-OCT. |
| Date of disclosure of the study information | 2019/01/30 |
| Last modified on | 2020/01/20 20:43:26 |
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Basic information
Public title
Posterior Vitreous Detachment of healthy young eyes by Swept source-OCT.
Acronym
PVD of healthy young eyes by SS-OCT
Scientific Title
Posterior Vitreous Detachment of healthy young eyes by Swept source-OCT.
Scientific Title:Acronym
PVD of healthy young eyes by SS-OCT
Region
| Japan |
Condition
Condition
posterior vitreous detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We observe posterior vitreous detachment(PVD) in young healthy eyes.
Basic objectives2
Others
Basic objectives -Others
We consider that relation of PVD and axial lengths, refraction, age and sex, and character in young healthy eyes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posterior Vitreous Detachment (only examination day)
Key secondary outcomes
axial lengths, refraction, visual aquity, ocular tension(only examination day)
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
| Device,equipment |
Interventions/Control_1
We take OCT images for healthy eyes in twenties and thirties.
We also measure the ocular axial length and refraction.
we take OCT only examination day.
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Best corrected visual acuity(BCVA) is over 1.0.
BCVA will be measured with a Landolt chart.
Key exclusion criteria
Eyes which BCVA is less than 1.0 with other intraocular diseases, such as uveitis, retinopathy, glacoma or significant media opacities were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Takagi |
Organization
Saint Marianna medical university
Division name
ophthalmology
Zip code
216-8511
Address
2-16-1 Sugao Miyamaeku Kawasakishi Kanagawa
TEL
0449778111
r2sekine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Reio |
| Middle name | |
| Last name | Sekine |
Organization
St. Marianna medical university
Division name
ophthalmology
Zip code
216-8511
Address
2-16-1 Sugao Miyamaeku Kawasakishi Kanagawa
TEL
0449778111
Homepage URL
r2sekine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna medical university
Institute
Department
Personal name
Funding Source
Organization
St. Marianna medical university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna medical university
Address
2-16-1 Sugao Miyamaeku
Tel
0449778111
r2sekine@marianna-u.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
| 2019 | Year | 01 | Month | 30 | 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
| 2019 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 01 | Month | 28 | Day |
Last modified on
| 2020 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040605
